FIBRINOGEN AND BLEEDING AFTER CARDIAC SURGERY
- Conditions
- 60 patients undergoing coronary artery bypass surgeryMedDRA version: 9.1Level: LLTClassification code 10011077Term: Coronary artery bypass
- Registration Number
- EUCTR2007-007157-31-SE
- Lead Sponsor
- Sahlgrenska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
•Males and females; age 18 years and above
•Patients eligible for a first-time coronary artery bypass graft (CABG) surgery with a preoperative fibrinogen plasma concentration < 3.7 g/L.
•Signed informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients undergoing reoperation
•Clinical or laboratory signs of known bleeding disorder,
•Clinical or laboratory signs of significant liver disease, or other significant disease or condition which in the investigators judgment may interfere with hemostasis
•Any medication with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel och warfarin are withdrawn at least five days before surgery. Heparin and low-molecular heparin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
•Administration of other investigational drugs within eight weeks preceding the pre-entry examination
•Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method