The Safety of Hand Surgery in the Anticoagulated Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954928
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):
Ryan Calfee, MD, Washington University School of Medicine

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
Hand Surgery

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
Actual Enrollment : 398 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Safety of Hand Surgery in the Anticoagulated Patient
Study Start Date : June 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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.

Primary Outcome Measures :
  1. postoperative hematoma [ Time Frame: 2 week, 4 week ]

Secondary Outcome Measures :
  1. 2 point discrimination [ Time Frame: 2 week, 4 week ]
  2. patient rated pain [ Time Frame: 2 week, 4 week ]
  3. patient rated function [ Time Frame: 2 week, 4 week ]
  4. ecchymosis [ Time Frame: 2week , 4 week ]
  5. joint range of motion [ Time Frame: 2 week, 4 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954928

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Ryan Calfee, MD Washington University School of Medicine

Responsible Party: Ryan Calfee, MD, Associate Professor of Orthopaedic Surgery, Washington University School of Medicine Identifier: NCT00954928     History of Changes
Other Study ID Numbers: 09-0567
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Ryan Calfee, MD, Washington University School of Medicine:
patients on anticoagulant medication

Additional relevant MeSH terms: