Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Trial Title: Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

NCT ID: NCT06428682

Condition: Breast Cancer
Blood Loss, Surgical

Conditions: Official terms:
Blood Loss, Surgical
Tranexamic Acid

Conditions: Keywords:
Autologous breast reconstruction
Free Flap
Tranexamic Acid

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Tranexamic acid
Description: 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.
Arm group label: TXA group

Intervention type: Drug
Intervention name: Placebo
Description: Control group will receive same volume equivalent of saline intravenously at the time of their surgery.
Arm group label: Placebo group

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).

Criteria for eligibility:
Criteria:
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

Gender: Female

Gender based: Yes

Gender description: Biological females

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Virginia Medical Center

Address:
City: Charlottesville
Zip: 22902
Country: United States

Status: Recruiting

Contact:
Last name: Rachel H Park, MD

Phone: 571-428-7278
Email: rhp7gu@hscmail.mcc.virginia.edu

Start date: May 13, 2024

Completion date: May 13, 2026

Lead sponsor:
Agency: University of Virginia
Agency class: Other

Source: University of Virginia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06428682