The Safety of Hand Surgery in the Anticoagulated Patient

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00954928
First received: August 5, 2009
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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
Hand Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Safety of Hand Surgery in the Anticoagulated Patient

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • postoperative hematoma [ Time Frame: 2 week, 4 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 2 point discrimination [ Time Frame: 2 week, 4 week ] [ Designated as safety issue: Yes ]
  • patient rated pain [ Time Frame: 2 week, 4 week ] [ Designated as safety issue: No ]
  • patient rated function [ Time Frame: 2 week, 4 week ] [ Designated as safety issue: No ]
  • ecchymosis [ Time Frame: 2week , 4 week ] [ Designated as safety issue: No ]
  • joint range of motion [ Time Frame: 2 week, 4 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954928

Locations
United States, Missouri
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
  More Information

Publications:
Responsible Party: Ryan Calfee, MD, Washigton University School of Medicine
ClinicalTrials.gov Identifier: NCT00954928     History of Changes
Other Study ID Numbers: 09-0567
Study First Received: August 5, 2009
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
hand
wrist
anticoagulation
surgery
patients on anticoagulant medication

Additional relevant MeSH terms:
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014