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

Recruiting
18 years of age
Both
Phase 4

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Overview

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.

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 details

Hematoma Postoperative

NCT05441592

University of Michigan

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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