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临床试验/NCT00954928
NCT00954928已完成不适用

The Safety of Hand Surgery in the Anticoagulated Patient

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2009年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Calfee, MD

Associate Professor of Orthopaedic Surgery

Washington University School of Medicine

研究点 (1)

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