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The Safety of Hand Surgery in the Anticoagulated Patient

The Safety of Hand Surgery in the Anticoagulated Patient

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00954928
Enrollment
398
Registered
2009-08-07
Start date
2009-06-30
Completion date
2015-06-30
Last updated
2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Surgery

Keywords

hand, wrist, anticoagulation, surgery, patients on anticoagulant medication

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.

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults over 18 years of age * Taking daily anti-coagulant medication * Having hand or wrist surgery

Exclusion criteria

* Surgery proximal to wrist * Pregnant females * INR \> 3.5

Design outcomes

Primary

MeasureTime frame
postoperative hematoma2 week, 4 week

Secondary

MeasureTime frame
2 point discrimination2 week, 4 week
patient rated pain2 week, 4 week
patient rated function2 week, 4 week
ecchymosis2week , 4 week
joint range of motion2 week, 4 week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026