Phase 3
N=44
Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01519245 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood). — 632; 789 mL — p=0.0493
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Drug); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Saskatchewan
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood). |
632; 789 | 0.0493 sig |
| PRIMARY Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery |
0; 0 | — |
| SECONDARY Volume of Blood Loss at 6 Hours |
342; 417 | 0.1876 |
| SECONDARY Volume of Blood Loss After 12 Hours |
464; 570 | 0.0930 |
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.
Eligibility Criteria
Inclusion Criterion:
- Patients scheduled for elective or urgent CABG of two to six vessels
Exclusion Criteria
Preoperative:
- Hemoglobin of less than 110g/L
- Under 18 years of age
- Body mass less than 75kg
- Presence of an intra-aortic balloon pump
- Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team
- Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure)
- Ejection fraction (EF) of less than 50%, as determined by echocardiogram or angiography
- Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg (as estimated by right ventricular systolic pressure (RVSP))
- Presence of infectious endocarditis
- Hepatic failure with impaired liver function, including International Normalized Ratio (INR) greater than 1.5
- Known diagnosed bleeding disorder
- History of heparin induced thrombocytopenia and thrombosis (HITT)
- Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10ml/hour
- Allergy to tranexamic acid
- Pregnancy
Intraoperative:
- Discovery of infectious endocarditis
- Need for cardiac surgical intervention in addition to planned coronary CABG
- Development of allergic reaction to tranexamic acid following intravenous infusion
Data sourced from ClinicalTrials.gov (NCT01519245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.