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

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University of Michigan

Status and phase

Enrolling
Phase 4

Conditions

Hematoma Postoperative

Treatments

Drug: Tranexamic acid injection
Other: No additional irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT05441592
HUM00210979

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Irrigation that contains tranexamic acid (TXA)
Experimental group
Treatment:
Drug: Tranexamic acid injection
No additional irrigation usual care
Other group
Treatment:
Other: No additional irrigation

Trial contacts and locations

1

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Central trial contact

Jenni Hamill, MPH; Sherry Tang, MD

Data sourced from clinicaltrials.gov

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