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Search / Trial NCT05554211

Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage

Launched by NORTHWESTERN UNIVERSITY · Sep 21, 2022

Trial Information

Current as of April 29, 2025

Withdrawn

Keywords

Mastectomy Tranexamic Acid

ClinConnect Summary

This clinical trial is studying the use of a medication called tranexamic acid (TxA) during a surgery known as a bilateral mastectomy, which is often done to prevent breast cancer. The researchers want to see if applying TxA directly to the surgical site can reduce fluid buildup and bleeding after the surgery, which could mean shorter time with drainage tubes and a smoother recovery. Participants will have one breast treated with TxA and the other with a saline solution (a simple saltwater) for comparison.

To participate, you must be a woman aged 18 or older who is scheduled for a bilateral mastectomy. However, this trial is not for everyone; men, women who have had previous mastectomies, and those with certain medical conditions or allergies to TxA cannot join. If eligible, you can expect to have the TxA applied during your surgery, and the study will help determine its effectiveness for future patients. This could be an important step in improving recovery experiences for women undergoing similar procedures.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Female aged 18 years or older
  • Scheduled or plans to schedule a bilateral mastectomy
  • Able to understand informed consent and sign it voluntarily
  • Exclusion Criteria:
  • Male without breasts
  • Females who have previously undergone either unilateral or bilateral mastectomy as they do not have breasts on which the drug could be tested
  • Patients with a hypersensitive or allergic reaction to TxA
  • Patients with an active clotting disorder
  • Patients with a subarachnoid hemorrhage within the past 3 months of screening
  • Patients on chronic, extracorporeal renal replacement therapy

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Robert L Walton, MD

Principal Investigator

Northwestern Feinberg School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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