Role of TXA in Patients Undergoing Breast Free Flap Reconstruction

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Virginia

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TXA groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Delta Hemoglobin

Post-op day 1 Hemoglobin - Pre-op Hemoglobin

Time frame
1 day after surgery
2

Transfusion rate

Transfusion rate during hospital stay

Time frame
Typically 0-72 hours after surgery

Secondary outcomes

1

Surgical complications

Thromboembolic event, hematoma, seroma, flap compromise/ failure

Time frame
30 days after surgery
2

Length of Stay

Total length of stay after surgery

Time frame
typically 2-4 days

Other outcomes

Sponsors and contacts

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