Cardiac Surgery Clinical Trial
Official title:
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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