Tranexamic Acid for Bleeding in Breast Surgery

Sponsored by Ottawa Hospital Research Institute

About this trial

Last updated 10 years ago

Study ID

20150264-01H

Status

Unknown

Type

Interventional

Phase

Phase 4

Placebo

Yes

Accepting

18+ Years

Female

Trial Timing

Ended 7 years ago

What is this trial about?

Bleeding is an important consideration in breast surgeries that involve large resections of soft tissues in the breast. Inappropriate bleeding during or after surgery, can lead to uncomfortable fluid buildup in the breasts known as a hematoma or seroma, which may require additional procedures or reoperation. Patients may experience a great deal of discomfort and additional costs as a result; additional hospital time and procedures also burdens health care spending. Tranexamic acid (TXA) is commonly used drug in many medical settings to reduce excessive bleeding; however, no such drug is standard practice in breast surgery. The aim of this study is to determine if TXA is superior to placebo in reducing the bleeding complications in breast surgeries, including reduction mammaplasty, mastectomy with and without immediate tissue expander and implant-based reconstruction, and oncoplastic breast surgery. This study is a randomized, double-blind, placebo-controlled trial. Patients undergoing these procedures will be randomly allocated to receive either TXA or placebo. Patients will be placed on a drug/placebo regimen of 3 doses/day for 6 days starting on the day of their surgery. The primary outcome is the incidence of hematoma and/or seroma formation following breast surgery. Cost analysis of the intervention will also be performed.

What are the participation requirements?

Inclusion Criteria

* Patient requires and is a candidate for any of the following surgical procedures: Reduction mammaplasty, mastectomy with and without immediate tissue expander and implant-based reconstruction, oncoplastic breast surgery.

* Patient has OHIP approval for surgery.

* Patient is willing and able (ie. English/French-speaking and cognitively intact) to read and complete patient diaries, demographic forms, and consent forms and be followed-up for a 2 weeks, 6 weeks, 12 weeks postoperatively.

* Patient is 18 years of age or older

Exclusion Criteria

* Patient is allergic to tranexamic acid

* Patient has a history or present laboratory signs of bleeding disorders (abnormal platelet counts, prothrombin time, partial thromboplastin time, etc.), coagulopathy or thromboembolic events

* Patient is being treated for a stroke

* Patient has a history of bleeding in the brain

* Patient has an acquired disturbance of colour vision

* Patient has a history of myocardial infarction within the last year

* Patient is presenting with unstable angina or severe coronary disease

* Patient has reduced renal function with plasma creatinine levels above 250 umol/L ix.

* Patient has haematuria

* Patient is currently using a form of birth control that contains estrogen and a progestin

* Patient has irregular menstrual bleeding of unknown cause

* Patient is unable to complete required forms due to language and cognitive problems

* Patient is not capable of communicating in, and understanding, English or French

* Patient is currently pregnant and is expected to be pregnant during any point of the study