Cardiac Surgery - Efficacy of Octaplas® and Fresh Frozen Plasma

Effects of octaplas and FFP on hemostasis and fibrinolysis in complex coagulopathy following
open‐heart surgery¹

Prospective open-label study in post-operative, open heart surgery patients who required plasma transfusion for acute bleeding or for risk of bleeding
Study was not powered to detect a difference in efficacy

STUDY OBJECTIVES: ASSESS EFFICACY AND TOLERABILITY OF OCTAPLAS IN PATIENTS UNDERGOING CARDIAC SURGERY
	Octaplas	FFP
N (Male/Female)	36 (20/16)	31 (17/14)
Median age (range)	69.5 years (34-79)	72 years (55-86)
Dosage (mL)	600	600
Median dosage (range)	8.5 mL/kg (5.5-14.2)	8.5 mL/kg (5.5-12.2)

Conclusions

Clinical hemostasis evaluation revealed no significant difference between octaplas and FFP. No adverse reactions were reported.

Reference:

Haubelt H, Blome M, Kiessling AH, et al. Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery. Vox Sang 2002; 82:9-14.

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

FOR U.S. HEALTHCARE PROFESSIONALS ONLY

The information on this website has been specifically created for U.S. healthcare professionals (HCPs)