Plasmafabriek Sanquin

Omniplasma

A pooled, SD treated and prion filtered plasma

Description

Omniplasma is a pooled, SD treated and prion reduced plasma which was added to Sanquin’s range of products in 2013.

On the advice of the Medical Advisory Board (Medische Adviesraad, MAR), Omniplasma was included in the range of products to replace quarantine plasma as the standard plasma medication for transfusions. Important considerations in this respect included the reduction of the risk of transmission of blood transmissible agents such as viruses and prions, and the further reduction of allergic reactions and the number of TRALI cases. In the National Users Council (Landelijke Gebruikersraad) of 7 November 2013, Sanquin announced that the stock of Omniplasma was sufficient to start phasing out the supply of quarantine plasma. This was, moreover, communicated in writing to the heads of all the blood transfusion laboratories.

Omniplasma is made from the plasma of voluntary and unpaid Dutch donors. The plasma is collected by Sanquin and converted by the producer into Omniplasma (diagram). One batch of Omniplasma consists of approximately 600 -1200 donations. As Omniplasma is a pooled product, it has a constant composition of coagulation factors and other plasma proteins.

Verpakking Omniplasma

Product information

  • The Falsified Medicines Directive also applies to Omniplasma

    •    New European Regulation has come into effect
    •    The Omniplasma product label has been changed and now has a 2D matrix (barcode) with an FMD code
    •    The scanning order of barcodes on the product label has changed
    •    Omniplasma bearing the new label will be introduced in phases
    •    Coordination with hospital pharmacists is necessary

    As of 9 February 2019, the Falsified Medicines Directive (FMD; 2016/161/EC) became effective. This European regulation must prevent falsified medicines entering the legal distribution chain (and, therefore, reaching patients). The FMD also applies to the medicine Omniplasma.

    The FMD is legislative and prescribes that medicines have two safety features:
    1) A unique identification feature, in the form of a 2D matrix, on the basis of which the authenticity and identity of the individual packaging of a medicine can be established. 
    2) A seal.

    The unique identifier contains the product code, serial number, batch number and the expiry date. The producer registers the serial numbers in a central database. Each serial number must be checked and deregistered from the database before being delivered to a patient.

    The intention of the FMD is to prevent counterfeit products being supplied to a patient. It is not necessary to link the serial number of the product to the patient!

    The 2D matrix is placed on the Omniplasma product label on a removable flag label. The changes to the label have consequences for the order of the barcodes. Currently, from left to right and from top to bottom, the Unit Identification Number (1), the blood group (2), the product code (3) and the shelf life (4) are displayed. On the new label the order is: 3-2-1-4. An example of the new label is shown below. 

    The second safety feature, the seal, is always present on Omniplasma; as this is the foil in which the unit is wrapped.

    Currently, Omniplasma is still being supplied which was produced and released before 9 February 2019, i.e. before the FMD came into effect. These products are covered by a transitional arrangement and may be used; they neither have to nor can be deregistered in the central database. It is anticipated that the first batches with the new label will be supplied at the end of 2019. The time of introduction will vary for each blood group. Blood group B may not be introduced until the end of 2020. This means that there is a transitional period in which the activities around Omniplasma differ for each blood group.

    Omniplasma is a medicine. As is the case for all medicines, the pharmacist or hospital pharmacist is responsible for complying with all the necessary actions. Therefore, in conjunction with the pharmacist or hospital pharmacist, agreements must be made in respect of the use and deregistration of Omniplasma with reference to the FMD.


    During production, purple elements are printed on the label.

  • Q & A serialisation Omniplasma

    What exactly is the Falsified Medicines Directive?
    The Falsified Medicines Directive (FMD; 2016/161/EC) became effective on 9 February 2019. This European regulation is intended to prevent falsified medicines entering the legal distribution chain (and, therefore, reaching patients).

    Does the Falsified Medicines Directive also apply to Omniplasma?
    The FMD applies to medicines which are only available on prescription and therefore also applies to Omniplasma.

     “Advanced therapy medical products which consist or are composed of tissue or cell material,’’ are not considered to be subject to the FMD in all pharmaceutical forms and concentrations. Is it possible to include Omniplasma in this category?
    Omniplasma does not fall under the category “Advanced therapy medical products (ATMP) which consist or are composed of tissue or cell material’’. Examples of ATMPs are: products for tissue manipulation, gene and somatic cell therapy. Omniplasma is a medicine which has plasma as its raw material. A large number of donor plasma units are pooled whereby cells and cell debris are removed. Subsequently, the pharmaceutical production process consists of Solvent Detergent treatment, removal of these chemicals and a prion reduction step. All this qualifies Omniplasma as a medicine. In this sense, it is, for example, comparable to IVIg and prothrombin complex concentrate. Medicines made from plasma are subject to the FMD. 

    Which safety features are added to the medicine?
    1) A unique identification feature, in the form of a 2D matrix, on the basis of which the authenticity and identity of the individual packaging of a medicine can be established. 
    2) A seal.

    Where is the 2D-matrix code placed?
    The 2D matrix is placed on a removable flag label which is, in turn, placed on the Omniplasma product label. 
    See the figure below, this shows:

    the product code
    the blood group
    the unit identification number
    the shelf-life
    the 2D matrix on the removable flag label























    What does the label look like for each blood group and which elements are included in the 2D matrix code?
    Example label bloedgroep A
    Example label bloedgroep B
    Example label bloedgroep AB
    Example label bloedgroep 0

    When reading out the 2D matrix code, the following features are cited:
    (01) the Global Trade Identification Number, GTIN
    (21) the Serial number
    (10) the Batch number
    (17) the Expiry date

    How was the position of the 2D matrix code determined?
    The manufacturer and the registration holder, Octapharma, submitted two proposals. These two proposals took account of: (i) the FMD and (ii) the technical feasibility. These two proposals were submitted to the working party Technology and Logistics (Techniek en Logistiek) of the National Users Council (Landelijke Gebruikersraad) and to the Dutch Hospital Pharmacists' Association (Nederlandse Vereniging van Ziekenhuisapothekers, NVZA). On the basis of these proposals, a decision was taken to place the 2D-matrix code on a removable flag label. The decisive factor was the flexibility the removable flag label offers.

    What information is shown on the 2D matrix code?
    The unique identifier contains the product code, serial number, batch number and the expiry date. The producer registers the serial numbers in a central database. Each serial number must be checked and deregistered from the database before being delivered to a patient.

    The new label does not have a separate code with the ZI-number, can this be found in another way?
    The 2D matrix code includes the GTIN (Global Trade Identification Number) associated with the product. In the pharmacists’ system (G-standard), a link has been made between the GTIN and the ZI-number.

    Is the unit identification number not sufficient?
    The EIN code is not sufficient, this does not include the elements required for the FMD, nor is it registered in the database. Moreover, this relates to another code (linear code, ISBT128).

    Does Omniplasma also have a seal?
    Each unit of Omniplasma is wrapped in sealed foil. This measure is sufficient.

    How does implementing the FMD in respect of Omniplasma affect the customers?
    • There is an additional action: deregistering the unit from the European database. This requires an ICT solution. 
    • The lay-out of the label has been changed and the linear codes corresponding to the EIN and the expiry date are no longer in the usual position. This could impact the scan order. 
    • It may be necessary to adjust the internal SOPs and to review the existing agreements with pharmacists and hospital pharmacists.

    When should Omniplasma be deregistered?
    The law states that the product should be deregistered when it is handed over (delivered to the patient or his/her representative). In practice, many pharmacists prefer deregistering it when they add it to their stock. 

    In respect of Omniplasma, account should be taken of the following:
    • The 2D matrix is attached to a part of the primary bag’s label. On delivery that bag is frozen and (therefore) not slippery. In addition, the primary bag is sealed in foil.
    • Only after thawing are the bag and primary label released. For the purposes of deregistration, the part that contains the 2D matrix is removable.

    There are two ways a unit can be deregistered:
    1: When it is frozen, in which case the 2D matrix has to be scanned through the foil. 
    2: After being thawed, when the product label can be scanned directly or when the flag label can be attached to a document and subsequently scanned. 

    Can the flag label be detached easily?
    After being thawed, the removable labels are easy to detach. And, at that moment, part of the label can be removed, you could try that beforehand.

    How long can the units without a 2D-matrix code still be used?
    Omniplasma which was produced and released before 9 February 2019, i.e. before the FMD came into effect, is subject to a transitional arrangement. These products neither have to be nor can be deregistered in the central database. As long as the shelf-life permits, a product can be used.

    Who is responsible for deregistering Omniplasma?
    Omniplasma is a medicine. As is the case for all medicines, the pharmacist or hospital pharmacist is responsible for complying with all the required actions. Actions may be delegated, but not the responsibility.

    Can Sanquin not deregister Omniplasma itself?
    Although Sanquin acts as a wholesaler, there is no opportunity for Sanquin to deregister the product prior to delivery. The regulation does not allow this.

    Is it possible to deregister via the LIMS?
    There are various ICT solutions which hospitals have chosen. LIMS is not, as a standard, equipped to deregister medicine. The responsibility for the deregistration lies with the pharmacist or hospital pharmacist. It is advisable to agree with the pharmacist, or hospital pharmacist, what the most suitable institution is locally and whether the LIMS is one of the options. If this is an option, the possibilities should be examined with the supplier of the LIMS.

    What happens if the Omniplasma is not deregistered?
    Medicines are not intended to be administered if their identity and authenticity have not been checked. The FMD is a European regulation that prescribes that certain actions must be carried out. Units which are not deregistered remain in the database. Eventually, medicines whose shelf-life has expired will be cleared out. 

    What happens if the Omniplasma is - accidentally - deregistered twice?
    Deregistration will cause an error message in the European database.

    When will the first batches with the 2D matrix code be delivered?
    Currently, Omniplasma is still being supplied which was produced and released before 9 February 2019, i.e. before the FMD came into effect. These products are covered by a transitional arrangements and may be used; they neither have to be nor can be deregistered in the central database. It is anticipated that the first batches with the new label will be delivered at the end of 2019. The time of introduction will vary for each blood group. Blood group B may not be introduced until the end of 2020. This means that there is a transitional period in which the activities around Omniplasma differ for each blood group.

    Should a unit of Omniplasma which cannot be administered (for example due to damage, leakage, flakes) also be deregistered?
    All units have to be deregistered.

  • Product information

    What is Omniplasma?
    Omniplasma is a pooled, SD treated and prion-reduced plasma

    Why is Omniplasma being added to Sanquin’s range of products?
    Omniplasma has been added to the product assortment on the advice of the Medical Advisory Board (MAR). Important considerations in this respect included the reduction of the risk of transmission of blood transmissible agents such as viruses and prions, and the further reduction of allergic reactions and the number of TRALI cases.  

    In this way, Sanquin is satisfying the wishes of its customers. On the basis of the MAR’s considerations, Sanquin decided to introduce Omniplasma as the preferred plasma for transfusions. In addition, the Q-plasma will remain available for certain symptoms.

    What are the differences between the current Q-plasma and Omniplasma?
    table has been drawn up to illustrate the differences between the two.

    What can I use Omniplasma for?
    Omniplasma is a pooled plasma, the indications are the same as those for Q-plasma. Omniplasma is a medicine and detailed information in respect of the indications, contraindications, warnings, storage and shelf-life are included in the specification of the product characteristics. When only a small volume is required, for example in the case of young children, you can also make use of the split Q-plasma units. Q-plasma is used for exchange transfusions.

    Why is Omniplasma a medicine?
    Omniplasma is a pooled product and has also undergone an industrial treatment process. On that basis, it qualifies as a medicine.

    Is Omniplasma the same as the previously supplied ESDEP?
    ESDEP was supplied by Sanquin in the period 1996-2002. This was a pooled SD-treated plasma. There was no prion reduction step in this process. At the time, the absence of a prion reduction step was the reason given for stopping the distribution of this product.

    What is the difference between Octaplas, Octaplas LG and Omniplasma?
    Octaplas is a pooled SD-treated plasma, the plasma comes from paid and unpaid donors who live abroad.

    Octaplas LG is a pooled SD-treated plasma that has undergone a prion reduction step, the plasma comes from paid and unpaid donors who live abroad.

    Omniplasma undergoes the same production process as Octaplas LG, except that in its case the plasma comes from voluntary and unpaid donors living in the Netherlands.

    During the production process of Octaplas LG and Omniplasma, the duration of the SD-treatment is shorter, this has a favourable effect on the protein S and alpha2-antiplasmin which are labile to SD chemicals. The shortened SD-treatment does not lead to any reduction in viral safety.

    My experience of using Octaplas has been good and I would like to continue using it, will it remain in your product range?
    No, Omniplasma will replace Octaplas. Omniplasma is prepared according to the same production process as the successor to Octaplas, the Octaplas LG, only the source of the plasma is different.

    Can I still order Q-plasma?
    There is only a limited quantity of quarantine plasma available for specific applications, for example paediatric administration, exchange transfusions for neonates and lgA-deficient patients.

    What additional measures are being taken to prevent viral transmissions?

    Each donor is screened, just as is applicable for the Q plasma supplied by Sanquin. In addition, NAT-tests are carried out for hepatitis A and Parvovirus B19. In the case of Parvovirus B19, the NAT-test does not have to be negative, but a value has been set for the permitted content of Parvovirus B19 DNA. Prior to production, the production pool is tested for Parvovirus B19, ultimately these pools may contain no more than 10 IU/µl Parvovirus B19 DNA.

    An SD treatment is applied during the Omniplasma preparation process. This treatment is effective and makes the lipid enveloped viruses, for example HIV, HCV, HBV, inactive (West Nile virus also belongs to these types of viruses).

    Neutralised antibodies against HAV and Parvovirus B19 are also present as pooled products.

    What additional measures are being taken to prevent prion transmission?
    The same exclusion criteria apply to Omniplasma as those for donors when it relates to a stay in the United Kingdom, use of growth hormones, cornea and cerebral membrane transplants, family members with Creutzfeld-Jacob disease. Additionally, in the Omniplasma preparation process, an affinity chromatography step is performed with a prion-specific ligand.

    What additional measures are being taken in respect of bacteria and parasites?
    The policy regarding travel to countries where there is malaria remains the same for Omniplasma. In addition, a sterile filtration (0.45 µm and 0.2 µm) is used as filling in the Omniplasma preparation process.  

  • Practical information

    Can Omniplasma be delivered to the clinical chemical laboratory?
    Yes, that is possible. Sanquin has focussed its way of working on supplying clinical chemical laboratories. To this end, an agreement between a hospital pharmacist and a clinical chemical laboratory is required. The hospital can draw this up itself or make use of an existing format . The text in this format cannot be changed. As Omniplasma is a medicine, the hospital pharmacist remains responsible. 

    Why is Omniplasma supplied per 10 units?
    A frozen product is fragile. By carefully packaging and delivering Omniplasma in an outer box (containing 10 units), the chance of breakage is reduced.

    What are the dimensions of the outer box and individual packages?

     

     

     

     

     

     

     

    Outer box: 
    26 x 15.5 x 20 cm
    Single package:  
    15 x 13 x 3 cm

    The Omniplasma labels differ from the labels for short-life blood products, does this have consequences?
    The labelling of the Omniplasma units meets the requirements of the Medicines Act (Geneesmiddelenwet) and (in respect of bar coding) meets the requirements of ISBT 128.
    Compared to the structure of the labels that Sanquin uses for short-life blood products, there are therefore a few differences, both in the layout and in the content of the bar codes. It is important that the software is designed for this, both for your laboratory system and product scanners.

    Coding of the units
    Below is an example of the label for a unit of fresh, frozen (quarantine) plasma.
    This label has six (6) bar codes, namely (from left to right and from top to bottom):
    1. The EIN (donation number);
    2. The blood group code;
    3. The collection date;
    4. The product code;
    5. The expiry date;
    6. The extra feature.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Below is an example of an Omniplasma label. This label has five (5) bar codes. The content is, from left to right and from top to bottom: (numbering in accordance with the Quarantine plasma label).
    1. EIN (unit number)
    2. The blood group code; this is encrypted: (blood group ABO) (Rhesus unknown) because Omniplasma has no RhD
    4. The product code
    5. The expiry date
    7. The medicine code

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    The differences and similarities are as follows:

     

     

     

     

     

     

     

     

     

    Coding of the boxes
    Sanquin supplies Omniplasma to hospitals in outer boxes of 10 pieces. Each box has a box label that states:

    The EINs of the 10 units in the box
    The box number
    There is a label on the box which corresponds to the units in the box; this displays the data of the batch in an ISBT 128 bar code (blood group, batch number, expiry date).

    This data is provided on the box for convenience and traceability, the information about the units in the box can be scanned and read without the box having to be opened. The units in the box can be quickly added to the stock, and the box as a whole can be kept in stock.

    What is the DBC code for Omniplasma?
    Since 1 January 2014, the healthcare validity code (zorgactiviteitcode) 190470 has been valid specifically for Omniplasma. Until that time, it was best to use 190404, so that it was clear that it related to plasma (that was not 190489, which was the residual group).

    Contact details
    Unit of Transfusion Medicine (UTG)
    The Transfusion Medicine Unit is part of the Sanquin Blood Bank division and provides advice to doctors, pharmacists, medical specialists and clinical chemists. Professionals can consult doctors from the UTG by telephone 24 hours a day, 7 days a week.

    Please contact UTG

    Account management

    If you have any questions or comments about the labelling, you should refer these to your account manager - preferably by email.

    Account managers:
    Utrecht, North Holland, Friesland and Groningen: Petra Hilarius
    Tel. +31 (0) 622765319 / Email: p.hilarius@sanquin.nl

    South Holland, Zeeland and West-Brabant, Marga van Hulst
    Tel. +31 (0) 651174125 / Email: m.vanhulst@sanquin.nl

    Limburg, East-Brabant, Gelderland, Overijssel and Drenthe: Esther van Ommen
    Tel. +31 (0) 651003127 / Email: e.vanommen@sanquin.nl

    Other questions and pharmaceutical complaints 
    Sanquin Plasma Products: marketing@sanquin.nl, telephone +31 (0) 20 512 38 80

    Under what conditions should Omniplasma be stored?
    Omniplasma has a shelf-life of four (4) years after being prepared. 

    How long can Omniplasma be stored once it is thawed?The SPC stipulates that after thawing, Omniplasma can be stored for five (5) days at +2 to +8°C and eight (8) hours at room temperature (+ 20 tot + 25°C). Medicines must be used in accordance with the SPC.
    Recently, a number of articles have been published about the thawed status of Octaplas LG (same process, different plasma source) and the effect on the coagulation factors.

     

  • Ordering, delivery and invoicing

    Where can I order Omniplasma?
    Omniplasma can be ordered from Sanquin Blood Bank, where the short-life blood products are also ordered. The product can be delivered to a clinical chemical laboratory, provided there is an agreement between the hospital pharmacy and the clinical chemical laboratory. 

    What are the product codes of Omniplasma?
    In contrast to the short-life blood products, Omniplasma has an individual product code per blood group.
    The table below provides an overview of the codes and descriptions:

     

     

     

     

    Z-index nummers Omniplasma

    15835111        omniplasma infvlst bloedgroep      0 bag 200ml
    15835073        omniplasma infvlst bloedgroep      a bag 200ml
    15835081        omniplasma infvlst bloedgroep      a+b bag 200ml
    15835103        omniplasma infvlst bloedgroep      b bag 200ml

    Can Omniplasma be delivered in emergency situations?
    Just like the short-life products, urgent delivery is possible. The smallest quantity that can be ordered is a box of ten pieces. Due to the longer shelf-life of Omniplasma, the risk that a product must be destroyed is low.

    What does Omniplasma cost?
    The price of Omniplasma is stipulated in the Sanquin Blood Bank price list. Because Omniplasma is a medicine, VAT must be levied. The low rate of VAT is applicable for medicines.

    How is Omniplasma invoiced?
    Omniplasma deliveries are invoiced once a month. You will receive a separate invoice for Omniplasma, even if the delivery takes place simultaneously with other products (erythrocytes, for example).

  • Medical questions about Omniplasma

    I have a question about using Omniplasma, where can I direct my question?
    The Transfusion Medicine Unit (UTG) is part of the Sanquin Blood Bank division and provides medical advice to doctors, pharmacists, medical specialists and clinical chemists. Professionals can consult doctors from the UTG by telephone 24 hours a day, 7 days a week.

    Please contact UTG

    I want to report a side-effect of Omniplasma, do I have to report this to Octapharma or IGZ?
    Although Omniplasma is classified by law as a drug, it is used as a transfusion product in clinical practice. The TRIP reporting system applies to transfusion products. This system also applies to Omniplasma. There is an agreement between TRIP and Sanquin and between TRIP and Lareb to ensure that reports of possible side effects end up with the appropriate authorities and are, as such, reported to the authorities, if necessary. In addition to TRIP, you can of course always report any side-effects to Sanquin or Lareb.

    What are the contraindications of Omniplasma?
    These are listed in the SPC:

    • IgA deficiency with documented antibodies against IgA.
    • Hypersensitivity to the active ingredient, and to any of the excipients or residues from the manufacturing process.
    • Serious protein S- deficiency.

    In a number of these situations, it is possible to switch to Q-plasma. In case of IgA deficiency, Sanquin has special plasma available from IgA-deficient donors.

    Why is serious protein S deficiency a contraindication?
    Just as the plasmin inhibitor alpha2-antiplasmin, Protein S is labile for the SD chemicals used. Therefore, the SD treatment has an effect on the concentration of these proteins. By adapting the duration of the SD treatment in the Omniplasma production process, the values of these two proteins have improved considerably compared to those of Octaplas in the past.

    Can Omniplasma be used in the apheresis of a TTP patient?
    Omniplasma can be used in the treatment of TTP. The indication is included in the SPC. In addition, there is literature about the composition of the product specifically for ADAMTS13 concentration and activity as well as factor H for the treatment of atypical HUS.

    Edel et al. Efficacy and Safety Profile of Solvent/Detergent Plasma in the Treatment of Acute Thrombotic Thrombocytopenic Purpura: A Single-Center Experience.  Transfus Med Hemother 2010;37:13–19 

    Heger et al. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sanguinis
    (2007) 92, 206–212

    To what extent should the volume difference between Q-plasma and Omniplasma be taken into account?
    A unit of Omniplasma contains 200 ml and Q-plasma contains 310 ml. Experience in Finland shows that a 15% increase was witnessed in a number of units. That would mean that generally the number of units suffices. Where dosing is by ml, as with TTP for example, more units will be needed.

    What are the benefits of a pooled product?
    Pooling results in a product with a standardised composition, which makes the clinical effect more predictable. In addition, there are also advantages with regard to transfusion reactions:

    • TRALI: by pooling both male and female plasma, any HLA and HNA antibodies are diluted and/or neutralised. Hemovigilance databases in other countries have not reported any
    • TRALIs when using Octaplas.
    • Allergic reactions: allergens are also diluted in the pool. Based on the Austrian hemovigilance database, a reduction of 15.6% has been seen in allergic reactions. N.B. reactions due to anti-IgA can also occur with this product, use should then be made of IgA-deficient Q-plasma.
  • Omniplasma documents

  • Publications

    Blood-borne infections
    Biesert L, et al. Solvent/Detergent Treatment of Human Plasma – A Very Robust Method for Virus Inactivation. Validated Virus Safety of Octaplas®, Vox Sang 1998; 74, Suppl. 1: 207-212

    Rollag H, et al. Viral Safety of Blood Derivatives by Immune Neutralization. Vox Sang. 1998;74 Suppl 1:213-7.

    Solheim B, et al. Viral safety of solvent / detergent-treated plasma. Transfusion.  2000 Jan; 40(1):84-90.

    Neisser-Svae A. et al. Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG ® Vox Sang. 2009 Oct;97(3):226-33.

    Heger A. et al. Removal of prion infectivity by affinity ligand chromatography during OctaplasLG® manufacturing – results from animal bioassay studies. Vox Sang. 2012 May;102(4):294-301

    Heger A. Biochemical quality of the pharmaceutically licensed plasma OctaplasLG® after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time. Vox Sang. 2009 Oct;97(3):219-25

    Hellstern P. et al. The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma. Transfus Med Hemother 2011;38:65–70

    Composition
    Heger A, et al. A biochemical comparison of a pharmaceutically licensed coagulation active plasma (Octaplas®) with a universally applicable development product (Uniplas) and single-donor FFPs subjected to methylene-blue dye and white-light treatment. Transfusion and Apheresis Science 35 (2006) 223–233

    Freeman J.W. A randomized trial of Solvent/Detergent-treated and Standard Fresh Frozen Plasma in the Treatment of the Coagulopathy seen during Orthotopic Liver Transplantation. Vox Sang. 1998;74 Suppl 1:225-9.

    Hellstern P. Solvent/detergent-treated plasma: composition, efficacy and safety. Curr Opin Hematol 11:346–350.

    Lawrie A.S. et al. The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables. Vox Sang. 2010 Oct;99(3):232-8.

    TRALI and HLA antibodies
    Sinnott P. et al. Presence of HLA antibodies in single-donor-derived fresh frozen plasma compared with pooled, solvent detergent-treated plasma (Octaplas®). Eur J Immunogenet. 2004 Dec;31(6):271-4.

    Sachs U.J.H. et al. White blood cell–reactive antibodies are undetectable in solvent/detergent plasma. Transfusion. 2005 Oct;45(10):1628-31.

    Sachs U.J.H. Pathophysiology of TRALI: current concepts. Intensive Care Med (2007) 33[Suppl 1]:S3–S11

    Wallis J.P. Transfusion-related acute lung injury (TRALI): presentation, epidemiology and treatment. Intensive Care Med (2007) 33[Suppl 1]:S12–S16

    Sachs U.J.H. Pathogenesis of transfusion-related acute lung injury and how to avoid this serious adverse reaction of transfusion. Transfusion and Apheresis Science 37 (2007) 273-282

    Chapman C. E. et al. Ten years of hemovigilance reports of transfusion-related acute lung injury in the United Kingdom and the impact of preferential use of male donor plasma. Transfusion. 2009 Mar;49(3):440-52

    Hemovigilantie/farmacovigilantie
    Flesland O. A comparison of complication rates based on published haemovigilance data. Intensive Care Med (2007) 33[Suppl 1]:S17–S21

    Baudoux et al. Hemovigilance: clinical tolerance of solvent-detergent treated plasma. Vox Sang. 1998;74 Suppl 1:237-9.

    Wiersum-Ossleton J.C. et al. Male-only fresh-frozen plasma for transfusion-related acute lung injury prevention: before-and-after comparative cohort study. Transfusion. 2011 Jun;51(6):1278-83.

    Torsvik Steinsvåg C. et al. Eight years with haemovigilance in Norway. What have we learnt? Transfus and Apher Sci 49 (2013) 548–552

    Chapman C. E. et al. Ten years of hemovigilance reports of transfusion-related acute lung injury in the United Kingdom and the impact of preferential use of male donor plasma. Transfusion. 2009 Mar;49(3):440-52

    TTP
    Scully M. et al. Cryosupernatant and solvent detergent fresh-frozen plasma (Octaplas) usage at a single centre in acute thrombotic thrombocytopenic purpura. Vox Sang. 2007 Aug;93(2):154-8.

    Kentouche K. et al. Remission of thrombotic thrombocytopenic purpura in a patient with
    compound heterozygous deficiency of von Willebrand factor-cleaving protease by infusion of solvent/detergent plasma
    .
     Acta Peadiatr 2002; 91: 1056-1059.

    Harrison C.N. et al. Plasma exchange with solvent/detergent-treated plasma of resistant thrombotic thrombocytopenic purpura. Br J Haematol. 1996 Sep;94(4):756-8.

    Evans G. et al. Solvent/detergent fresh frozen plasma as primary treatment of acute thrombotic thrombocytopenic purpura. Clin Lab Haematol. 1999 Apr;21(2):119-23.

    Efficacy and Safety Profile of Solvent/Detergent
    Edel E. et al. Plasma in the Treatment of Acute Thrombotic Thrombocytopenic Purpura: A Single-Center Experience. Transfus Med Hemother 2010;37:13–19

    Heger A. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sang. 2007 Apr;92(3):206-12.

    Coagulopathie
    Freeman J.W. A randomized trial of Solvent/Detergent-treated and Standard Fresh Frozen Plasma in the Treatment of the Coagulopathy seen during Orthotopic Liver Transplantation. Vox Sang. 1998;74 Suppl 1:225-9.

    Williamson L.M. A randomized trial of Solvent/Detergent-treated and Standard Fresh Frozen Plasma in the Coagulopathy of liver disease and liver transplantation. Transfusion. 1999 Nov-Dec;39(11-12):1227-34.

    Inbal A. et al. Evaluation of Solvent/Detergent-treated Plasma in the management of patients with hereditary and acquired coagulation disorders. Blood Coagul Fibrinolysis. 1993 Aug;4(4):599-604.

    Salooja N. Severe factor V deficiency and neonatal intracranial haemorrhage: a case report. Haemophilia (2000), 6, 44-46

    De Jonge J. et al. Fibrinolysis During Liver Transplantation Is Enhanced by Using Solvent/Detergent Virus-Inactivated Plasma (ESDEP®). Anesth Analg 2002;94:1127–31

    Haugaa H et al. Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent Treated Plasma. Clin Med Res. 2014 Jan 10. [Epub ahead of print]

    Thawing and storing once thawed
    Buchta C. et al. Stability of coagulation factors in thawed, solvent/detergent treated plasma during storage at 4 °C for 6 days. Vox Sang. (2004) 87, 182–186

    Heger A. et al. Stability of solvent/detergent-treated plasma and single-donor fresh-frozen plasma during 48 h after thawing. Transfus Apher Sci. 2005 Nov;33(3):257-67. Epub 2005 Oct 3.

    Keller M.K. et al. Clotting factor activity in thawed Octaplas® LG during storage at 2–6 °C for 6 days from a quality assurance point of view. Transfusion and Apheresis Science 46 (2012) 129–136

    Keller M.K. et al. Thawed solvent/detergent-treated plasma: too precious to be wasted after 6 hours? Blood Transfus 2012; 10: 360-7

    Beck K.H. et al. Thawing of Fresh Frozen Plasma and Virus-Inactivated Plasma – Suitability of Microwave Oven Infusion Therapy and Transfusion Medicine 01/2002; 29(6):313-317

    Heger A. et al. A biochemical quality study of a pharmaceutically licenced coagulation active plasma (Octaplas®) thawed by the SAHARA-III dry tempering system compared to the regular use of a water bath Vox Sang. 2008 Jan;94(1):48-55

    Heger A. et al. Thawing of Pooled, Solvent/Detergent-Treated Plasma octaplasLG®: Validation Studies Using Different Thawing Devices. Transfus Med Hemother. 2017 Apr; 44(2): 94-98.

    A. Neisser-Svae et al. Five‐day stability of thawed plasma: solvent/detergent‐treated plasma comparable with fresh‐frozen plasma and plasma frozen within 24 hours Transfusion 2016; 56; 404-409

    Use for children
    Chekrizova V. Solvent–detergent plasma: use in neonatal patients, in adult and paediatric patients with liver disease and in obstetric and gynaecological emergencies. Transfusion Medicine, 2006, 16, 85–91

    Haller W. et al. Successful Isolated Liver Transplantation in a Child with Atypical Hemolytic Uremic Syndrome and a Mutation in Complement Factor H. American Journal of Transplantation 2010; 10: 2142–2147

    Salooja N. Severe factor V deficiency and neonatal intracranial haemorrhage: a case report. Haemophilia (2000), 6, 44-46

    Witt V. et al. Total plasma exchange using Octaplas; safety and coagulation parameters in children (abstract). Journal of Clinical Apheresis 28 (2013), 129

    Camazine MN et al. Outcomes Related to the Use of Frozen Plasma or Pooled Solvent/Detergent-Treated Plasma in Critically Ill Children. Pediatr Crit Care Med. 2017 May;18(5):e215-e223