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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05441592
Other study ID # HUM00210979
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 15, 2022
Est. completion date June 2024

Study information

Verified date July 2023
Source University of Michigan
Contact Sherry Tang, MD
Phone 734-936-5895
Email syqtang@med.umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy - For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable. - For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable Exclusion Criteria: - Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion - Current use of systemic anticoagulation - Hypersensitivity to tranexamic acid - Concomitant use of combined hormonal contraceptives - Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid - History of acquired defective color vision - History of subarachnoid hemorrhage - Pregnancy - History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid injection
The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
Other:
No additional irrigation
There will be no additional irrigation after the standard surgical procedure.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA Up to approximately 4 weeks after surgery
Secondary Number of participants experiencing a major thromboembolic event related to the study drug Major thromboembolic events include, but are not limited to: deep vein thrombosis, pulmonary embolism, stroke Up to approximately 4 weeks after surgery
Secondary Number of participants experiencing major complications other than hematoma Major complications include, but are not limited to: infection, seroma, hypersensitivity reaction to TXA, renal impairment Up to approximately 4 weeks after surgery
See also
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Completed NCT04947514 - Use of Tranexamic Acid in Reduction Mammoplasty Phase 4
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Completed NCT04559646 - Application of the "Haemoblock" in Pacemaker Patients
Recruiting NCT03535116 - The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery Phase 4
Not yet recruiting NCT04918576 - Topical Tranexamic Acid for Bilateral Breast Reduction Surgery Phase 3
Not yet recruiting NCT04918589 - Tranexamic Acid for Alloplastic Breast Reconstruction Phase 3
Active, not recruiting NCT04554407 - Study to Evaluate the Performance of a Sustained Vacuum System N/A