Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

NCT06428682 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HSR220370
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).

Conditions

Breast Cancer; Blood Loss, Surgical

Keywords

Autologous breast reconstruction; Free Flap; Tranexamic Acid

Outcome Measures

Primary Outcomes (2)

• Delta Hemoglobin

  Post-op day 1 Hemoglobin - Pre-op Hemoglobin

  1 day after surgery

• Transfusion rate

  Transfusion rate during hospital stay

  Typically 0-72 hours after surgery

Secondary Outcomes (2)

• Surgical complications

  30 days after surgery

• Length of Stay

  typically 2-4 days

Study Arms (2)

TXA group

EXPERIMENTAL

Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

Drug: Tranexamic acid

Placebo group

PLACEBO COMPARATOR

Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline

Drug: Placebo

Interventions

Tranexamic acid DRUG

Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery.

TXA group

Placebo DRUG

Control group will receive same volume equivalent of saline intravenously at the time of their surgery.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

You may not qualify if:

• Subjects with ages \<18 years
• Allergy to TXA
• Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
• Subjects who have anemia (defined as baseline hemoglobin \<8 g/dL
• Subjects who cannot read or understand English
• Subjects who are pregnant

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22902, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• John Stranix, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Park, MD

CONTACT

5714287278; RHP7GU@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Plastics Surgery

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: May 13, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

US (1)