The Safety of Hand Surgery in the Anticoagulated Patient

Hand Surgery Clinical Trial

Official title:

The Safety of Hand Surgery in the Anticoagulated Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954928
• Other study ID #: 09-0567
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: June 26, 2015
• Start date: June 2009
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hand Surgery

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative hematoma		2 week, 4 week	Yes
Secondary	2 point discrimination		2 week, 4 week	Yes
Secondary	patient rated pain		2 week, 4 week	No
Secondary	patient rated function		2 week, 4 week	No
Secondary	ecchymosis		2week , 4 week	No
Secondary	joint range of motion		2 week, 4 week	No