Comparison of Solvent/Detergent-Inactivated Plasma and Fresh Frozen Plasma under Routine Clinical Conditions

Abstract

Background: Reduced levels of protein S (PS) and α₂-antiplasmin α₂-AP) in solvent/detergent virus-inactivated plasma (S/D-VIP) might induce an imbalance of plasma coagulation factors and inhibitors in patients transfused. We investigated 40 patients (23 fresh frozen plasma (FFP), 17 S/D-VIP, random distribution by a list calculated by statisticians) who suffered from dilution coagulopathy, liver disease, disseminated intravascular coagulation (DIC), polytrauma or were connected to extracorporeal circulation. Study Design and Methods: The following markers of activated coagulation (MAC) were measured: Prothrombin fragment F1+2 (F1+2), fibrin monomers (FM), D-dimers (DD), thrombin-antithrombin (TAT) and plasmin-antiplasmin (PAP) complexes as well as fibrinogen degradation products (FgDP), and additionally antithrombin III (antithrombin), protein C (PC), PS and α₂-AP. Blood was taken only just before and 1 h after the first plasma replacement (2 units). No additional blood products were transfused before the second blood withdrawal. Pre- and posttransfusion (pre/post) values of all parameters measured were compared within the same group and between both groups. Statistical evaluation of the data was done by Wilcoxon’s paired test for data in the same plasma group and by the test of Mann and Whitney for data comparison between both plasma groups. Results: Average pretransfusion values of all inhibitors for both plasma groups were in the same range and increased after transfusion, except for PS in both groups. Whereas the pre/post values did not differ significantly in the FFP group, antithrombin (p = 0.02), PC (p = 0.0005), and α₂-AP (p = 0.02) showed a significantly higher increase in the S/D-VIP group. Considering the pre/post differences between both plasma groups, there were no significant differences. The same was true for MAC measured pre- and posttransfusion. Conclusion: Data showed no significant difference between both plasma groups, indicating that S/D-VIP plasma behaves as FFP under the study conditions employed.

Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials

“…One study was identified that compared FFP with a pathogen‐inactivated formulation of FFP in a clinically heterogeneous group of 35 patients with DIC (criteria for diagnosis not defined), dilution coagulopathy, or trauma (Beck et al , 2000). Outcome measures in this trial were laboratory based.…”

“…Outcome measures in this trial were laboratory based. No significant differences in the levels of different markers of coagulation factors were reported (Beck et al , 2000). An additional RCT comparing FFP with platelet transfusion in patients receiving massive transfusion was identified (Reed et al , 1986).…”

“…Although the outcome measures in many trials covered clinical endpoints, in a small number of RCTs no clinically relevant outcomes were defined (Liu et al , 1994; Deorari et al , 1995; Boyd et al , 1996; Beck et al , 2000). As highlighted in the text, for those clinical outcomes reported in identified trials comparing FFP with no FFP or with potentially ‘active’ controls (e.g.…”

“…FFP is recommended (BCSH, 1992(BCSH, , 2004a for both prevention and treatment of bleeding (Kurtz, 1995). Six trials evaluating FFP administration in patients with liver disease were identified [one (Beck et al, 2000) has been included in the later, more representative section]. Most commonly, these Gazzard et al (1975) FFP 300 ml/ 6 h (600 ml if prothrombin time ratio >7), cross-over trial (n ¼ 10)…”

“…Of the three identified trials, two described methods of random allocation (Gross et al, 1982;Beck et al, 2000), and one incorporated blinding to clinicians and patients (Reed et al, 1986). No clear primary outcomes were defined in any of the three studies.…”