NCT02299947

Bloodtranfusions After Aortic Surgery

Comparison of a Single Dose Fibrinogen With Placebo and the Number of Blood Transfusions After Ascending Aorta Surgery (FIBTEG Study)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Hemorrhage
• Thoracic Aneurysm

Interventions

Type	Name	Description
DRUG	Haemocomplettan P
DRUG	Placebo

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-04-26
• Completion: 2018-04-26
• First posted: 2014-11-24
• Last updated: 2019-05-10

Locations

1 site across 1 country: Netherlands