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

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05441592

Collaborator

(none)

500

Enrollment

Location

Arms

21.6

Anticipated Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematoma Postoperative	Drug: Tranexamic acid injection Other: No additional irrigation	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irrigation that contains tranexamic acid (TXA)	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 usual care	Other: No additional irrigation There will be no additional irrigation after the standard surgical procedure.

Arm

Intervention/Treatment

Experimental: Irrigation that contains tranexamic acid (TXA)

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 usual care

Other: No additional irrigation

There will be no additional irrigation after the standard surgical procedure.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Edwin Wilkins, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Edwin G. Wilkins, Professor of Surgery, University of Michigan

ClinicalTrials.gov Identifier:

NCT05441592

Other Study ID Numbers:

HUM00210979

First Posted:

Jul 1, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Edwin G. Wilkins, Professor of Surgery, University of Michigan

Breast reduction

Gender-affirming mastectomy

Tranexamic Acid

Additional relevant MeSH terms:

Hematoma

Tranexamic Acid

Study Results

No Results Posted as of Aug 18, 2022