Fibrinogen and Bleeding After Cardiac Surgery

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Criteria

Inclusion Criteria:

• Males and Females

• Age 18 years and above

• Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L

• Signed informed consent to participate in the study

Exclusion Criteria:

• Patients undergoing redo surgery

• Clinical or laboratory signs of bleeding disorder

• Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis

• Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.

• Administration of other investigational drugs within eight weeks preceding the preentry examination

• Pregnant or lactating women