The Safety of Hand Surgery in the Anticoagulated Patient

June 26, 2015 updated by: Ryan Calfee, MD, Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults over 18 years of age having hand surgery while on anti-coagulant medication. Control subjects undergoing hand and wrist surgery without anticoagulant medications will be enrolled if they are over 18 years of age and able to consent to research participation. Patients on Coumadin with INR values less than or equal to 3.5 will be eligible for study inclusion.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative hematoma
Time Frame: 2 week, 4 week
2 week, 4 week

Secondary Outcome Measures

Outcome Measure
Time Frame
2 point discrimination
Time Frame: 2 week, 4 week
2 week, 4 week
patient rated pain
Time Frame: 2 week, 4 week
2 week, 4 week
patient rated function
Time Frame: 2 week, 4 week
2 week, 4 week
ecchymosis
Time Frame: 2week , 4 week
2week , 4 week
joint range of motion
Time Frame: 2 week, 4 week
2 week, 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-0567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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