Tranexamic Acid in Gender Mastectomy

NCT04372940 | Withdrawn Phase 4 DMC FDA Drug

• 3 other identifiers: 2019-0410-GMA539730SMPH/SURGERY/DENTL-PLASTC SRGY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively.

Conditions

Surgery

Keywords

gender mastectomy; top surgery

Outcome Measures

Primary Outcomes (1)

• Days until drain removal

  up to 30 days post-op

Secondary Outcomes (8)

• Total drain output in mL for total time drain is in place

  up to 30 days post-op

• Drain fluid output in mL/day

  up to 30 days post-op

• Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery

  up to 30 days post-op

• Amount of fluid evacuated (mL) - hematomas

  up to 30 days post-op

• Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery

  up to 30 days post-op

Study Arms (2)

Intervention Side: TXA Irrigation

EXPERIMENTAL

2.5% tranexamic acid will be applied directly to the wound via bulb irrigation and left in place for 5 minutes in the wound bed

Drug: Tranexamic Acid Irrigation

Control Side: Saline Irrigation

PLACEBO COMPARATOR

Contralateral side will serve as a control

Other: Saline Irrigation

Interventions

Tranexamic Acid Irrigation DRUG

Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.

Also known as: TXA

Intervention Side: TXA Irrigation

Saline Irrigation OTHER

Saline will serve as the control.

Control Side: Saline Irrigation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: transgender males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing gender mastectomy
• English speaking

You may not qualify if:

• History of thrombotic event (ie deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
• genetic disorder that increases risk of thrombosis
• use of estrogens at time of surgery
• pregnancy

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Katy Gast, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: TXA would be randomized to one side with the other acting as a control

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)