Recruiting

TXA

Sponsor:

University of Virginia

Code:

NCT06428682

Conditions

Breast Cancer

Blood Loss, Surgical

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid

Placebo

Study Details

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

Study ID

NCT06428682

Start date

May 13, 2024

Status verified date

Jun, 2024

Completion date

May 13, 2026

Anticipated

Primary completion date

May 13, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TXA group

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

placebo comparator: Placebo group

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

Interventions

Tranexamic acid

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.

Placebo

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

Primary outcome measure

  • Delta Hemoglobin [ Time Frame: 1 day after surgery ]
  • Transfusion rate [ Time Frame: Typically 0-72 hours after surgery ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22902

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Jun 5, 2024

Last verified

Jun, 2024

Keywords

  • Autologous breast reconstruction
  • Free Flap
  • Tranexamic Acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-06-05.