Status:
COMPLETED
Plasma Transfusion in Major Vascular Surgery
Lead Sponsor:
Naestved Hospital
Collaborating Sponsors:
Statens Serum Institut
Conditions:
Aortic Aneurysm, Abdominal
Arterial Occlusive Diseases
Eligibility:
All Genders
41-99 years
Brief Summary
BACKGROUND * Major blood loss is frequent in open repair of ruptured and intact abdominal aortic aneurysm (AAA) as well as in aorto-bifurcated prosthesis insertion due to aortoiliac occlusive disease...
Detailed Description
STATISTICAL ANALYSIS PLAN The primary analysis will be a stratified cox regression model. STRATIFICATION: * type of surgery/condition (ruptured AAA vs intact AAA vs aorto-iliac occlusive disease, s...
Eligibility Criteria
Inclusion
- Open abdominal aortic repair with the insertion of prosthesis for either
- intact (elective or symptomatic) AAA
- ruptured AAA
- aorto-iliac occlusive disease
- Requiring massive transfusion defined as 10 units or more of any blood product(\*) transfused on the same date (source DTDB)
- (\*) = Allogeneic packed RBCs, FFP, cryoprecipitate, or platelets. Cryoprecipitate will account for 4 units of FFP in the FFP:RBC ratio.
Exclusion
- Surgery time limited to \< 50 minutes (DVR)
- No prosthesis inserted (DVR) AND operation date (DVR) equal to the death date (CPR)
- Excluding patients with surgery time less than 50 minutes or cases where no prosthesis has been inserted is expected to minimize survival bias from patients exsanguinating in the operation theater before blood products can be delivered. Intentionally, it may also exclude cases where surgery was considered futile and halted.
Key Trial Info
Start Date :
January 1 1997
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
17000 Patients enrolled
Trial Details
Trial ID
NCT04514575
Start Date
January 1 1997
End Date
December 31 2018
Last Update
January 28 2021
Active Locations (1)
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1
Slagelse Hospital
Slagelse, Region Sjælland, Denmark, 4200