The Safety of Hand Surgery in the Anticoagulated Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- postoperative hematoma
研究概览
简要总结
If operating on the anticoagulated patient has been safe for one of the investigators' surgeons for the past 10 years then providing prospective data that substantiates this could prevent complications related to the discontinuation of anticoagulation for hand surgery patients in the future.
详细描述
All eligible patients will be offered study enrollment pre-operatively. Demographic data collected during clinical interaction that will be gathered for research purposes and will included patient height, weight, age, anticoagulant medication(s) used with dosage/duration of use, indication for anticoagulant medication, and current INR if on warfarin. Preoperative examination will include measures of 2 point discrimination in the digits, distance of the fingertips from the distal palmar crease upon flexion, and the patient-based outcome surveys that are to be collected after surgery (Quick DASH, SF-12, Visual Analog Scales pain/swelling). These patients will then undergo the appropriate surgical procedure without discontinuing their anticoagulant medication.
To ensure that patients are not being placed at increased risk, this study's protocol will not alter the surgical practices of the attending surgeons involved. Specifically, all surgeons perform their hand and wrist surgery under tourniquet control but differ in whether the tourniquet is deflated prior to wound closure. Each surgeon will be free to manage the tourniquet as they feel appropriate. The placement of would drains will remain at the discretion of the attending surgeon on a case-by-case basis.
Local anesthetics may be injected but none will be mixed with epinephrine.
Procedures: (if applicable) Obtaining pre-operative INR values when appropriate, and performing surgery while continuing anticoagulants is already standard care for one faculty member. All post-operative care except the completion of the Quick DASH and Short Form 12, and visual analog ratings is part of standard clinical care. Research questionnaires should take no more than 20 minutes to complete per visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age
- •Taking daily anti-coagulant medication
- •Having hand or wrist surgery
排除标准
- •Surgery proximal to wrist
- •Pregnant females
- •INR > 3.5
结局指标
主要结局
postoperative hematoma
时间窗: 2 week, 4 week
次要结局
- patient rated pain(2 week, 4 week)
- patient rated function(2 week, 4 week)
- 2 point discrimination(2 week, 4 week)
- ecchymosis(2week , 4 week)
- joint range of motion(2 week, 4 week)
研究者
Ryan Calfee, MD
Associate Professor of Orthopaedic Surgery
Washington University School of Medicine
