Neoplasms

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Breast Neoplasms

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Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline

Tranexamic acid

Normal Saline

Minh Huynh, MD

Mark McRae, MD, FRCSC

Sophoceles Voineskos, MD, FRCSC

Ronen Avram, MD, FRCSC

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.

In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.

If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.

One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).

The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo).

Intervention: Topical application of 3 grams of tranexamic acid (30 mL of 100 mg/mL) diluted in 10 mL of normal saline in the breast.

Placebo: Topical application of 40 mL of 0.9% normal saline to the breast.

Patients will be randomized on the REDCap system. Their assignment will be made available to research team member, which will be preparing syringes with either TXA or placebo.

Tranexamic Acid for Alloplastic Breast Reconstruction

Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial

Total number of days drains in situ with standard discharge criteria

Number of repeat operations required for patient related to complication

Rate of subsequent interventions including aspiration, repeat drain insertion or other

Ultrasound findings of hematoma or seroma, if applicable

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tranexamic Acid for Alloplastic Breast Reconstruction	NCT04918589	Hematoma Postop... Breast Cancer Tranexamic Acid	Tranexamic acid Normal Saline	18 Years - 99 Years	McMaster University
Tranexamic Acid for Alloplastic Breast Reconstruction	NCT04918589	Hematoma Postop... Breast Cancer Tranexamic Acid	Tranexamic acid Normal Saline	18 Years - 99 Years	McMaster University

Spots Global Cancer Trial Database for alloplastic breast reconstruction