The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery.

The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.

Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amphia Hospital
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

Inclusion Criteria:

• Gender; male/ female

• Age: ≥ 18 year

• Elective cardiac surgical patients

• Coronary artery bypass graft (CABG) (conventional, E.CCO)

• Aortic valve replacement (AVR) (conventional)

• Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)

• Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)

• Bentall

• Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)

Exclusion Criteria:

• MVR/MPL (minimal invasive, Port Access Surgery)

• Maze (minimal invasive, via Thoracoscopy)

• AVR (minimal invasive, via mini Sternotomy)

• off-pump procedures

• Emergency operations

• Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)