The Safety of Hand Surgery in the Anticoagulated Patient
|ClinicalTrials.gov Identifier: NCT00954928|
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : June 29, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||398 participants|
|Observational Model:||Case Control|
|Official Title:||The Safety of Hand Surgery in the Anticoagulated Patient|
|Study Start Date :||June 2009|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
Those patients taking Coumadin, Plavix, Aspirin, Lovenox.
Those patients having hand or wrist surgery who do not take any anticoagulant medication.
- postoperative hematoma [ Time Frame: 2 week, 4 week ]
- 2 point discrimination [ Time Frame: 2 week, 4 week ]
- patient rated pain [ Time Frame: 2 week, 4 week ]
- patient rated function [ Time Frame: 2 week, 4 week ]
- ecchymosis [ Time Frame: 2week , 4 week ]
- joint range of motion [ Time Frame: 2 week, 4 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954928
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ryan Calfee, MD||Washington University School of Medicine|