Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2026-05-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Breast Cancer Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TXA group

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

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type 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.

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No