Minimization of Bleeding Complications Through Utilization of Perioperative Tranexamic Acid in Breast Surgery: A Randomized Double-blinded Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 800
- 主要终点
- Incidence of hematoma or seroma formation in breast surgical site as assessed by clinical examination.
研究概览
简要总结
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.
详细描述
Background:
Aberrant bleeding is an important consideration in breast surgery, which can involve large resections of soft tissues in the breasts. Hematomas and/or seromas are common complications with these procedures, and can lead to further complications, such as flap necrosis. Seromas, perhaps the commonest complication, are documented to occur at rates as high as 85% in certain breast procedures. Hematoma rates are typically lower than that of seroma, ranging from 1% to 2% in mastectomy procedures and 5% to 8% in reduction mammaplasty. These bleeding complications pose an obvious risk to patient safety, and their management can result in significant costs to patients and healthcare alike.
Tranexamic acid (TXA), also known by the brand name Cyklokapron® from Pfizer™, is a lysine analogue used to prevent and/or treat bleeding by competitively blocking the activation of plasminogen to plasmin, thereby preventing plasmin from binding to blood clots. Tranexamic acid is used safely in several medical and surgical settings, such as cone biopsies, epistaxis and hyphaema control, and dental surgery. This antifibrinolytic medication is commonly used in many surgical procedures, namely cardiac and orthopedic surgery, for the purposes of preventing blood loss. TXA has been demonstrated to effectively reduce perioperative blood loss and transfusion rates in many different surgical procedures, such as cardiac, urology, gynecology, and orthopedic surgeries, without any significant safety concerns.
Despite these findings, there is a clear paucity of studies on TXA in breast surgery. There are currently no studies exploring perioperative TXA use in breast reduction, and only one study in breast surgery overall. This study by Oertli et al. looked at the use of TXA in mastectomy or lumpectomy with axial dissection, in a randomized placebo-controlled trial (RCT). Seroma rate was shown to be reduced by 10% with a reduction in TXA versus placebo. However, due to a low power of the study, Oertli et al. were unable to determine statistical significance.
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tranexamic Acid
Tranexamic acid will be provided as an intravenous infusion (1g in 100mL 0.9% NaCl solution [1% TXA] at 5 ml/min) 20 minutes pre-operatively, followed by an additional intravenous dose of the same dosing parameters postoperatively. Oral tablet doses containing 1 g of TXA (2x 500mg tablets) per dose will be administered to the patient to be taken orally by the patient according to a standard regimen; the first tablet dose will be taken on the same day as the surgery, in the evening. The patient will then take one tablet dose three times a day for a total of five days following the surgery (one dose in the morning, one dose mid-day, and one dose in the afternoon) for a 6 day total regimen.
干预措施: Tranexamic Acid (Drug)
Placebo Control
Placebo control will be either 100 ml of 0.9% NaCl solution or tablets of similar appearance containing no medicinal ingredients; placebo will be administered according to the same regimen as the intervention group.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of hematoma or seroma formation in breast surgical site as assessed by clinical examination.
时间窗: 12 weeks following the operation
Hematoma or seroma formation in the breast surgical site(s) will be identified by surgeon on clinical examination during patient follow-up within 12 weeks post-operatively.
次要结局
- Incidence of additional procedures following initial breast operation to address hematoma or seroma(12 weeks following the operation)
- Drainage volume as measured from Jackson-Pratt drain or percutaneous drainage(12 weeks following the operation)
- Blood transfusion volume(During surgical operating time, during post-operative hospital admission time (1-7 days on average).)
- Number of days spent in hospital(12 weeks following the operation)
- Cost associated with bleeding complications(12 weeks following the operation)
- Tranexamic Acid Adverse Events:(12 weeks following the operation)
- Incidence of secondary breast operation(12 weeks following the operation)