The effect on blood loss of topical and intravenous tranexamic acid in cardiac surgery patients: a randomized placebo-controlled trial

Phase 4

Completed

• Conditions: post-operative blood loss; 10007593

• Registration Number: NL-OMON38995
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

* Gender; male/ female
* Age: * 18 year
* Elective cardiac surgical patients
o Coronary artery bypass graft (CABG) (conventional, E.CCO)
o Aortic valve replacement (AVR) (conventional)
o Mitral valve replacement/ Mitral valve repair (MVR/MPL) (conventional)
o Tricuspid valve replacement/ Tricuspid valve repair (TVR/ TPL)
o Bentall
o Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/MAZE)

Exclusion Criteria

* MVR/ MPL (minimal invasive)
* Maze (minimal invasive)
* AVR (minimal invasive)
* off-pump procedures
* Acute patients
* patient with increased or decreased bleeding tedency (FV leiden, prot C, S deficiency,
anti-thrombin deficiency, prothrombinmutation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is 12 hours post-operative blood loss and is<br /><br>assessed by 12 hours post-operative chest tube production. post-operative chest<br /><br>tube production 12 hours after surgical procedure</p><br>