Comparison of a single dose fibrinogen with placebo and the number of blood transfusions after ascending aorta surgery (FIBTEG study)

Phase 4

Completed

• Conditions: 10064477; 10046973; 10002363; loss of functionality of the thoracic aorta; postoperative coagulopathy

• Registration Number: NL-OMON41387
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 82

Inclusion Criteria

* > 18 years
* Competent
* Scheduled for ascending aorta replacement using CPB
* Signed informed consent

Exclusion Criteria

* Presence thrombosis or previous myocardial infarction
* Severe recorded atherosclerosis
* Hypersensitivity to any component of FC
* Congenital or acquired impaired clotting
* Hypofibrinogenemia (<1 g / l)
* The use of vitamin K antagonists, direct thrombin inhibitors, antiplatelet or in the last 5 days before surgery
* Previous cardiothoracic surgery
* Perioperative exclusion; CPB time <90 minutes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of transfused allogenic blood products, up to 24 hours after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Postoperative blood loss (= thoracic drainage volume) up to 24 hours after<br /><br>surgery.<br /><br>* Re-operation during postoperative hospitalization.<br /><br>* Admission time in Intensive Care Unit (ICU) and hospital.<br /><br>* Hospital mortality</p><br>