Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

University of Virginia

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer; Blood Loss, Surgical

Treatments: Drug: Placebo; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06428682

HSR220370

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

TXA group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo