Phase 4
Completed N=97
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Bleeding · Surgical Blood Loss
Source: ClinicalTrials.gov NCT03376061 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Median Volume of Mediastinal Fluid Collected From Participants — 500; 540 mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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 )
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. Informational only — not medical advice.