drugset / Trial / NCT02542306
Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 25 mg/kg | — |
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 50 mg/kg | — |