Status:
COMPLETED
Fibrinogen and Bleeding After Cardiac Surgery
Lead Sponsor:
Sahlgrenska University Hospital
Conditions:
Complications
Bleeding
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 fibrin...
Eligibility Criteria
Inclusion
- 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
- 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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00968045
Start Date
April 1 2009
End Date
May 1 2015
Last Update
May 20 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiothoracic Surgery unit, Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden, 41345