Phase 4 N=97 Randomized Quadruple-blind Prevention

Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

Bleeding · Surgical Blood Loss

Bottom Line

View on ClinicalTrials.gov: NCT03376061 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Median Volume of Mediastinal Fluid Collected From Participants — 500; 540 mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Population Health Research Institute
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Volume of Mediastinal Fluid Collected From Participants	500; 540	—
SECONDARY Number of Participants With Seizures	0; 1	—
SECONDARY Number of Participants With Mortality	1; 1	—
SECONDARY Number of Participants With RBC Transfusion	19; 23	—
SECONDARY Number of Participants With Re-operation for Bleeding or Tamponade	0; 1	—
SECONDARY Median Number of Hours Participants Spent in ICU	23; 26	—
SECONDARY Mean Concentration of TxA in Plasma Collected From Participants	0.58; 1.10	—

Summary

The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.

Eligibility Criteria

Inclusion Criteria

Male or female >= 18 years old
Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
Provide written informed consent

Exclusion Criteria

Poor (English) language comprehension
Minimally invasive valve surgery
Off-pump procedures
Emergency operations
Known history of increased bleeding disorder
Thromboembolic disease
Allergy to tranexamic acid
Severe renal impairment (eGFR <30 mL/min/1.73m2 )

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03376061). 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.