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CompletedNCT00954928Updated Jun 29, 2015

The Safety of Hand Surgery in the Anticoagulated Patient

An observational study in Hand Surgery, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-29.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
398
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hand Surgery

Keywords

  • hand
  • wrist
  • anticoagulation
  • surgery
  • patients on anticoagulant medication
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Surgery proximal to wrist
  • Pregnant females
  • INR > 3.5
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
398 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. postoperative hematoma

    Time frame: 2 week, 4 week

Secondary outcomes

  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

07

Study locations

1 site
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
08

References and documents

Publications

  • Lindsley RC. Perioperative management of systemic oral anticoagulants in patients having outpatient hand surgery. J Hand Surg Am. 2008 Sep;33(7):1205-7. doi: 10.1016/j.jhsa.2008.05.026. PubMed 18762121 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00954928
Lead sponsor
Washington University School of Medicine
Responsible party
Ryan Calfee, MD (Associate Professor of Orthopaedic Surgery, Washington University School of Medicine) — Principal investigator
First posted
Aug 7, 2009
Start date
Jun 2009
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 29, 2015

Study contacts

Ryan Calfee, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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