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OpenTrials
Completed

NCT Number: NCT00954928

The Safety of Hand Surgery in the Anticoagulated Patient

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2009
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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