NCT00333697

Brief Summary

To determine the rate of thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld on the basis of a negative comprehensive duplex ultrasound examination. Participants are followed for three months after a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis develop. Any such symptoms are verified by objective tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 21, 2011

Status Verified

March 1, 2011

Enrollment Period

5.2 years

First QC Date

June 2, 2006

Last Update Submit

March 17, 2011

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosisDuplex ultrasoundPulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Symptomatic VTE

    The rate of objectively-confirmed thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld based on a single, negative comprehensive duplex ultrasound.

    Three months

Interventions

Comprehensive Duplex Ultrasound (diagnostic study)OTHER

A sigle duplex ultrasound examination of the deep venous system of the leg(s) suspected of deep vein thrombosis. Deep veins of the leg are examined for evidence of thrombosis from the inguinal ligament to the level of the malleolus.

Eligibility Criteria

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

You may qualify if:

  • Be referred for suspected first ipsilateral episode of acute DVT of the lower extremities.
  • Be \> 18 y.o.
  • Provide written informed consent

You may not qualify if:

  • Pregnant.
  • Compression ultrasonography cannot be performed due to physical or technical reasons.
  • Long-term follow-up will not be possible due to geographic inaccessibility, homelessness or lack of a telephone.
  • Therapeutic doses of an anticoagulant have been received for more than 24 hours before enrollment.
  • Informed consent cannot be obtained.
  • Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermoutain Medical Center

Murray, Utah, 84157, United States

Location

LDS Hospital

Salt Lake City, Utah, 84093, United States

Location

Related Publications (4)

  • Stevens SM, Elliott CG, Chan KJ, Egger MJ, Ahmed KM. Withholding anticoagulation after a negative result on duplex ultrasonography for suspected symptomatic deep venous thrombosis. Ann Intern Med. 2004 Jun 15;140(12):985-91. doi: 10.7326/0003-4819-140-12-200406150-00007.

    PMID: 15197015BACKGROUND

  • Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, Kovacs G, Mitchell M, Lewandowski B, Kovacs MJ. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003 Sep 25;349(13):1227-35. doi: 10.1056/NEJMoa023153.

    PMID: 14507948BACKGROUND

  • Schellong SM, Schwarz T, Halbritter K, Beyer J, Siegert G, Oettler W, Schmidt B, Schroeder HE. Complete compression ultrasonography of the leg veins as a single test for the diagnosis of deep vein thrombosis. Thromb Haemost. 2003 Feb;89(2):228-34.

    PMID: 12574800BACKGROUND

  • Elias A, Mallard L, Elias M, Alquier C, Guidolin F, Gauthier B, Viard A, Mahouin P, Vinel A, Boccalon H. A single complete ultrasound investigation of the venous network for the diagnostic management of patients with a clinically suspected first episode of deep venous thrombosis of the lower limbs. Thromb Haemost. 2003 Feb;89(2):221-7.

    PMID: 12574799BACKGROUND

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Scott M Stevens, MD

    Intermountain Medical Center

    PRINCIPAL INVESTIGATOR

  • Charles G Elliott, MD

    Intermountain Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 21, 2011

Record last verified: 2011-03

Locations

US(2)