FResh frozen plasma, Omniplasma & SDP comparison of Transfusion reactions, Efficacy & DVT study (FROSTED)
Plasma transfusions are indicated in cases of massive bleeding, Thrombotic Thrombocytopenia Purpura (TTP), Hemolytic-Uremic Syndrome (HUS), liver disease, deficiencies in clotting factors for which concentrates do not exist (e.g. Factor V), and a few other disease states. The two most commonly used forms of plasma for transfusion are Quarantine Fresh Frozen Plasma (Q-FFP) and Solvent/Detergent treated Plasma (SDP). Q-FFP is a one-donor to one-recipient product in which the donor is first tested (for HIV I/II, HVB, HVC, syphilis and, in the case of first-time donors, HTLV I/II) before the plasma is frozen in quarantine. Following this quarantine period, the donor is retested (given the window period of the concerned pathogens) before the product is released for use. SDP, on the other hand, is a pooled product made from around a thousand units of FFP also first tested for viral markers but for which the donors do not undergo secondary testing. Thus it must endure a robust pathogen reduction process to ensure its safety.
As of 2013, a form of Solvent/Detergent treated Plasma (SDP) known as Omniplasma™ is available for use in the Netherlands. It is a pooled, detergent treated product, prion filtered and made exclusively from Dutch donor plasma 1) and has replaced Q-FFP as the standard plasma used for plasma transfusions in the Netherlands. The rationale behind this switch is the expected reduction in risk of transfusion reactions 1-8) and prion infections, and the increase in efficacy 7-8) as compared to Quarantined Fresh Frozen Plasma (Q-FFP). These improvements have been seen in other countries switching from Q-FFP to SDP. However some studies suggest SDP also carries a higher risk of Deep Venous Thrombosis (DVT) 9-10) and hyperfibrinolysis 11-12) than Q-FFP.
To compare Omniplasma™ and Quarantine Fresh Frozen Plasma (Q-FFP) with regard to cost effectiveness and safety, specifically transfusion reactions, in patients receiving plasma transfusions in the Netherlands during the course of the study.
FROSTED is a non-experimental study organized by the Sanquin Blood Foundation, the Dutch haemovigilance organization TRIP (Transfusion and transplantation Reactions In Patients), and the Leiden University Medical Centre department of Clinical Epidemiology, in collaboration with both academic and peripheral hospitals throughout the Netherlands. Data will be collected from hospital records and the existing national databases designed to record transfusion reactions and incidents in the transfusion chain, and used to evaluate the safety, efficacy, and cost effectiveness of the two products.
All patients receiving a plasma transfusion (either Omniplasma™ or Q-FFP) in the Netherlands during the period of the study.
Main study endpoints
The main study endpoints are the types and number of transfusion reactions, along with type and number of units of plasma and erythrocytes used and details regarding the patient population receiving the products.
We will compare incidences of transfusion reactions, effectiveness, and price of treatment for each of the two products. Given similar research performed in other countries, we expect the switch to Omniplasma™ to decrease both adverse events and the total volume of plasma transfused nationally.
1. Omniplasma. (2013). Retrieved November 8, 2013, from http://www.sanquin.nl/producten-diensten/plasmaproducten/producten/omniplasma/
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