CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Tranexamic Acid 20mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01519245
NCT01519245Phase 3Completed
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Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery

University of Saskatchewan·interventional·Posted Jan 26, 2012·Updated Jul 2, 2013

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid and normal saline for Coronary Artery Disease. Completed, enrolled 44 participants.

Detailed Summary

The goal of this project is to determine whether the use of tranexamic acid, a clot-promoting drug, applied topically over the heart in coronary artery bypass graft surgery (CABG) will reduce post operative blood loss. The investigators' hypothesis is that the use of a tranexamic acid-containing cardiac bath prior to chest closure will result in a statistically significant reduction in blood loss and transfusion requirements in patients who undergo CABG.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
Countries--
CollaboratorsSaskatoon Health Region

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2012
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.4 years ago

Interventions

Tranexamic Aciddrug

Solution containing 2 grams (20mL) tranexamic acid + normal saline (50mL), for a total volume of 70mL poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction.

normal salinedrug

A total volume of 70mL of normal saline poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction. Identical in appearance to the trial drug, and is visually indistinguishable.