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

Hematoma Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441592
• Other study ID #: HUM00210979
• Status: Recruiting
• Phase: Phase 4
• 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
• 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)

Related Conditions & MeSH terms

• Hematoma
• Hematoma Postoperative

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