Tranexamic Acid for Alloplastic Breast Reconstruction

Phase 3

• Conditions: Tranexamic Acid; Breast Cancer; Hematoma Postoperative
• Interventions: Drug: Normal Saline; Drug: Tranexamic acid

• Registration Number: NCT04918589
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06
• Study Start: 2022-08
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	40 mL topical of 0.9% normal saline
Tranexamic Acid	Tranexamic acid	3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline

Primary Outcome Measures

Name	Time	Method
Seroma	2 weeks	Incidence rate of seroma
Hematoma	2 weeks	Incidence rate of hematoma

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	2 weeks	Number of repeat operations required for patient related to complication
Imaging findings	2 weeks	Ultrasound findings of hematoma or seroma, if applicable
Drain output	24 hours	Total drain output (mL) at 24 hours
Days with drains	2 weeks	Total number of days drains in situ with standard discharge criteria
Reintervention rate	2 weeks	Rate of subsequent interventions including aspiration, repeat drain insertion or other

Trial Locations

Locations (3)

St. Joseph's Healthcare, King Campus; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Healthcare, Charlton Campus; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital, Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada