A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation

BACKGROUND: Virus inactivation of pooled fresh-frozen plasma (FFP) by the s olvent/detergent (SD) method results in a loss of approximately 20 percent of factor VIII. This study aimed to assess the efficacy of SD-treated plasm a in correcting the coagulopathy associated with liver disease and liver tr ansplantation. STUDY DESIGN AND METHODS: Forty-nine patients with coagulation deficits due to liver disease, who required FFP for invasive procedures or liver transp lantation, were randomly assigned to receive either FFP or SD-treated plasm a. Patients were assessed for side effects, correction of coagulopathy over 24 hours, and seroconversion for viral markers 6 to 18 months after treatm ent. RESULTS: In the liver disease group, equal correction of clotting factors a nd partial thromboplastin time was seen with FFP and SD-treated plasma, wit h a similar return to baseline values over 24 hours. There was greater corr ection of the International Normalised Ratio in patients receiving SD-treat ed plasma (p = 0.037), but this patient group had higher baseline values th an recipients of FFP (p = 0.024). Liver transplant patients also showed equ ivalent correction of coagulopathy with the same dose of FFP and SD-treated plasma. The use of other blood components during transplantation was ident ical in the two treatment groups. No seroconversions were seen for HIV or h epatitis B or C virus. One patient who had received FFP seroconverted for h uman parvovirus B19. Apparent seroconversion for hepatitis A virus seen at 9 to 13 months in four other patients was probably due to detection of pass ively transferred antibodies, as later testing of these patients gave negat ive results. Minor side effects were rare in both groups. CONCLUSION: SD-treated plasma is an efficacious source of coagulation facto rs for patients with liver disease who are undergoing biopsy or transplanta tion. Assessment of seroconversion for viral markers in recipients of plasm a-derived products and plasma components should include consideration of th e possibility that passively transferred antibodies were detected.