Fibrinogen and Bleeding After Cardiac Surgery (Fibro-3)

Sahlgrenska University Hospital

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Complications

Bleeding

Treatments

Drug: Fibrinogen

Study type

Interventional

Funder types

Other

Identifiers

NCT00968045

EudraCT-nr:2007-007157-31

Fibro 01/07

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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