Bloodtranfusions After Aortic Surgery (FIBTEG)

St. Antonius Hospital

Status and phase

Terminated

Phase 4

Conditions

Hemorrhage

Thoracic Aneurysm

Treatments

Drug: Haemocomplettan P

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02299947

NL45370.100.14

Details and patient eligibility

About

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

Full description

Cardiothoracic surgery (CTC) is associated with blood loss and an increased risk for impaired coagulation by the use of a CBP. Coagulation is a process of primary hemostasis by adhesion of trombocytes and aggregation, followed by secondary coagulation and fibrin formation. During CTC fibrinogen is the first coagulation factor which reaches critical concentration necessary for clotting. Point of Care clotting assay with thromboelastography (TEG) provides qualitative information on coagulation factors and clot strength. Specific coagulation factor correction of impaired clotting improves clot strength and may reduces the number of perioperative allogeneic blood transfusions, resulting in possible reduction of postoperative blood loss and reduction of the risk of re-operation in the short and long term. The hypothesis of this study is that a single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions in patients with clinically impaired clotting, verified by TEG.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elective surgery for thoracic aneurysm

Exclusion criteria

Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration <1g/L