NCT01895101

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

The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Amphia Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Loss
• Tranexamic Acid
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	2 gr tranexamic acid	This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).
DRUG	Saline	This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-07-10
• Last updated: 2015-05-20
• Results posted: 2015-04-10

Locations

1 site across 1 country: Netherlands