Bloodtranfusions After Aortic Surgery

Phase 4

Terminated

• Conditions: Hemorrhage; Thoracic Aneurysm
• Interventions: Drug: Haemocomplettan P; Drug: Placebo

• Registration Number: NCT02299947
• Lead Sponsor: St. Antonius Hospital

Brief 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.

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2018-04-26
• Study Completion: 2018-04-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haemocomplettan P	Haemocomplettan P	Study patients that receive Haemocomplettan P
NaCl 0.9%	Placebo	Study patients that receive NaCl 0.9%

Primary Outcome Measures

Name	Time	Method
Number of transfused blood products	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Mortality	30 day mortality
Blood loss	24 hours after surgery
Re-operation	30 day after surgery

Trial Locations

Locations (1)

St Antonius hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands