Coagulopathy during surgery for the repair of Extent 4 Thoraco-Abdominal Aortic Aneurysms - feasibility study of the use of Fibrinogen Concentrate by infusion in place of Fresh Frozen Plasma. - Fibrinogen as an alternative to FFP in aortic surgery.
Phase 1
- Conditions
- Coagulation disturbance during thoracoabdominal aneurysm repair.
- Registration Number
- EUCTR2009-016709-41-GB
- Lead Sponsor
- HS Lothian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Undergoing elective extent 4 thoracoabdominal aneurysm repair.
2. Over 18 years of age.
3. Able to give written informed consent.
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
Exclusion Criteria
1. Re-do surgery.
2. Surgery for ruptured aneurysm.
3. Pregnancy.
4. Females of child-bearing age (less than 45 years) not using medically approved method of contraception.
5. Congenital coagulopathy.
6. Known allergy to study drug.
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