COMPLETED

A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

Talk to us

Conditions

Hematoma PostoperativeBreast reductionGender-affirming mastectomyTranexamic Acid

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

Quick Facts

Study Start:2022-08-15
Study Completion:2024-10-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05441592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
  2. * For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
  3. * For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
  1. * Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
  2. * Current use of systemic anticoagulation
  3. * Hypersensitivity to tranexamic acid
  4. * Concomitant use of combined hormonal contraceptives
  5. * Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
  6. * History of acquired defective color vision
  7. * History of subarachnoid hemorrhage
  8. * Pregnancy
  9. * History of renal impairment or serum Creatinine \>1.5 milligrams per deciliter (mg/dL)

Contacts and Locations

Principal Investigator

Edwin Wilkins, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Edwin Wilkins, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-15
Study Completion Date2024-10-22

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2024-10-22

Terms related to this study

Keywords Provided by Researchers

  • Breast reduction
  • Gender-affirming mastectomy
  • Tranexamic Acid

Additional Relevant MeSH Terms

  • Hematoma Postoperative