drugset / Trial / NCT02542306

Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest

NCT02542306

Phase 2 Unknown 150 enrolled Hongjia Zhang Beijing Anzhen Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown. Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below 1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the non-FC-treated group.

Timeline

Start
2013-07
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 25 mg/kg
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 50 mg/kg

Indications