Haemocomplettan® P During Elective Complex Cardiac Surgery

Phase 2/3 Completed 120 enrolled Isala CSL Behring · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

Timeline

Start: 2011-02
Primary completion: 2014-12
Completion: 2014-12

Outcome

Missed primary endpoint

paper administration of fibrinogen concentrate, compared with placebo, resulted in no significant difference in the amount of intraoperative blood loss. PMID 28241354 ↗

Publications

Bilecen S, de Groot JA, Kalkman CJ, Spanjersberg AJ, Brandon Bravo Bruinsma GJ, Moons KG, Nierich AP. Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial. JAMA. 2017 Feb 21;317(7):738-747. doi: 10.1001/jama.2016.21037.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrinogen Concentrate Human	Protein / enzyme biologic	—	Intravenous