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

Phase 4

Recruiting

• Conditions: Hematoma Postoperative
• Interventions: Other: No additional irrigation; Drug: Tranexamic acid injection

• Registration Number: NCT05441592
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-07-01
• Study Start: 2022-08-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No additional irrigation usual care	No additional irrigation	-
Irrigation that contains tranexamic acid (TXA)	Tranexamic acid injection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants experiencing a major thromboembolic event related to the study drug	Up to approximately 4 weeks after surgery	Major thromboembolic events include, but are not limited to: deep vein thrombosis, pulmonary embolism, stroke
Number of participants experiencing major complications other than hematoma	Up to approximately 4 weeks after surgery	Major complications include, but are not limited to: infection, seroma, hypersensitivity reaction to TXA, renal impairment

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States