Liver Disease and Transplantation - Efficacy of Octaplas® and FFP

Effects of octaplas and FFP in the management of coagulopathy in liver disease and liver transplantation^1,2

Prospective, single-blind, randomized study was designed to investigate the safety and efficacy of octaplas compared with standard FFP in adult patients with coagulopathies due to liver disease or liver transplantation
Study was not powered to detect a difference in efficacy

STUDY OBJECTIVES: ASSESS EFFICACY AND TOLERABILITY OF OCTAPLAS IN CORRECTING THE COAGULOPATHY ASSOCIATED WITH LT AND LD
	Octaplas	FFP
N (Male/Female)	LT: 12 (5/7) LD: 13 (10/3)	LT: 13 (7/6) LD: 11 (8/3)
Median age (range)	LT: 47 years (20-66) LD: 50 years (30-69)	LT: 51 years (23-67) LD: 52 years (26-66)
Median dosage (range)	LT: 44 mL/kg (25-104) LD: 12 mL/kg (11-15)	LT: 44 mL/kg (7-98) LD: 13 mL/kg (11-17) Conclusions

LT = Liver Transplant, LD = Liver Disease.

Conclusions

Similar correction of increased international normalized ratio (INR) and prolonged aPTT values achieved by 24 hours post-treatment
Similar number of blood components transfused with both octaplas and FFP
No viral transmission or infections reported. No febrile reactions observed. One patient had a mild reaction to octaplas (nausea and pruritus)

References:

Williamson LM, Llewelyn NC, Fisher JP, et al. A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation. Transfusion 1999; 39:1227-1234.
Freeman, JW, Williamson LM, Llewelyn C, et al. A randomized trial of solvent/detergent and standard fresh-frozen plasma in the treatment of the coagulopathy seen during orthotopic liver transplantation. Vox Sang 1998; 74(suppl 1):225- 229.

Indications and Important Safety Information for octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion

Please see octaplas full Prescribing Information.

Indications and Important Safety Information for octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion

Please see octaplas full Prescribing Information.

Indications and Usage

Octaplas^® is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

Contraindications

Octaplas is contraindicated in patients with immunoglobulin A (IgA) deficiency; severe deficiency of protein S; history of hypersensitivity to fresh frozen plasma or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to octaplas.

Warnings and Precautions

Transfusion reactions can occur with ABO blood group mismatches. Administration of octaplas must be based on ABO-blood group compatibility. High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure. Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin (also named plasmin inhibitor). Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with volumes exceeding one milliliter of octaplas per kg per minute. octaplas is made from human plasma and may carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions

The most common adverse reactions observed in ≥ 1% of patients included pruritus, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension.

Please see octaplas full Prescribing Information

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