The Safety of Hand Surgery in the Anticoagulated Patient
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Anticoagulated patients Those patients taking Coumadin, Plavix, Aspirin, Lovenox. |
|
| Control patients Those patients having hand or wrist surgery who do not take any anticoagulant medication. |
Outcome Measures
Primary Outcome Measures
- postoperative hematoma [2 week, 4 week]
Secondary Outcome Measures
- 2 point discrimination [2 week, 4 week]
- patient rated pain [2 week, 4 week]
- patient rated function [2 week, 4 week]
- ecchymosis [2week , 4 week]
- joint range of motion [2 week, 4 week]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults over 18 years of age
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Taking daily anti-coagulant medication
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Having hand or wrist surgery
Exclusion Criteria:
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Surgery proximal to wrist
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Pregnant females
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INR > 3.5
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Ryan Calfee, MD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 09-0567