Bloodtranfusions After Aortic Surgery

Hemorrhage Clinical Trial

— FIBTEG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02299947
• Other study ID #: NL45370.100.14
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2014
• Est. completion date: April 26, 2018

Study information

• Verified date: May 2019
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 26, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm, Thoracic
• Hemorrhage
• Thoracic Aneurysm

Intervention

Drug:
• Haemocomplettan P

• Placebo

Locations

Country	Name	City	State
Netherlands	St Antonius hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of transfused blood products		24 hours after surgery
Secondary	Blood loss		24 hours after surgery
Secondary	Re-operation		30 day after surgery
Secondary	Mortality		30 day mortality