NCT00954928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

6 years

First QC Date

August 5, 2009

Last Update Submit

June 26, 2015

Conditions

Hand Surgery

Keywords

handwristanticoagulationsurgerypatients on anticoagulant medication

Outcome Measures

Primary Outcomes (1)

  • postoperative hematoma

    2 week, 4 week

Secondary Outcomes (5)

  • 2 point discrimination

    2 week, 4 week

  • patient rated pain

    2 week, 4 week

  • patient rated function

    2 week, 4 week

  • ecchymosis

    2week , 4 week

  • joint range of motion

    2 week, 4 week

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adults over 18 years of age
  • Taking daily anti-coagulant medication
  • Having hand or wrist surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related 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.

    PMID: 18762121BACKGROUND

Study Officials

  • Ryan Calfee, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

US(1)