Tranexamic acid injection for Hematoma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Michigan, Ann Arbor, MI
Hematoma+1 More
Tranexamic acid injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.

Eligible Conditions

  • Hematoma

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to approximately 4 weeks after surgery

Week 4
Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA
Number of participants experiencing a major thromboembolic event related to the study drug
Number of participants experiencing major complications other than hematoma

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Irrigation that contains tranexamic acid (TXA)
1 of 1
Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: Tranexamic acid injection · No Placebo Group · Phase 4

Irrigation that contains tranexamic acid (TXA)
Drug
Experimental Group · 1 Intervention: Tranexamic acid injection · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid injection
2018
Completed Phase 4
~1730

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 4 weeks after surgery
Closest Location: University of Michigan · Ann Arbor, MI
Photo of university of michigan comprehensive cancer center 1Photo of university of michigan comprehensive cancer center 2Photo of university of michigan comprehensive cancer center 3
2022First Recorded Clinical Trial
2 TrialsResearching Hematoma
1005 CompletedClinical Trials

Who is running the clinical trial?

University of MichiganLead Sponsor
1,597 Previous Clinical Trials
6,328,557 Total Patients Enrolled
Edwin Wilkins, MDPrincipal InvestigatorUniversity of Michigan

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Any skin incision pattern or pedicle is acceptable.
For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.