Tranexamic Acid for Alloplastic Breast Reconstruction

McMaster University

Status and phase: Not yet enrolling; Phase 3

Conditions: Breast Cancer; Hematoma Postoperative; Tranexamic Acid

Treatments: Drug: Tranexamic acid; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04918589

13104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are 18 years or older;
• Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

Exclusion criteria

• Taking therapeutic anticoagulation;
• Taking antiplatelet drugs;
• Pregnant or breast feeding;
• Allergic to TXA;
• Cannot provide informed consent;
• Alloplastic reconstruction is not performed immediately after mastectomy;
• Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Normal Saline

Placebo Comparator group

Description:

40 mL topical of 0.9% normal saline

Treatment:

Drug: Normal Saline