Whole-leg Ultrasound in Pregnant Patients (CLOT-3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Intermountain Health Care, Inc.
Sponsor:
Information provided by (Responsible Party):
Scott M. Stevens, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01319474
First received: March 17, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

This study seeks to determine the rate of thromboembolic complications (blood clots), including death attributed to thromboembolic disease, when anticoagulation (blood thinner) therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a whole-leg compression ultrasound shows no DVT. Patients are followed for three months after the ultrasound to determine if a blood clot is diagnosed during that time.


Condition Intervention
Deep Vein Thrombosis
Other: Whole-leg compression ultrasound

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of Whole-leg Ultrasound for Diagnosis of Deep Vein Thrombosis in Pregnant Patients

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Symptomatic VTE [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    The primary outcome measure will be DVT or PE, or death attributable to thromboembolic disease confirmed by objective testing in the 3 months following enrollment.


Secondary Outcome Measures:
  • Isolated iliac DVT [ Time Frame: At enrollment ] [ Designated as safety issue: Yes ]
    The exact rate of isolated iliac vein DVT identified on futher testing performed on the basis of suspicious doppler ultrasound findings.


Estimated Enrollment: 268
Study Start Date: February 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ultrasound for suspected DVT
Enrolled subjects suspected to have deep vein thrombosis undergo whole-leg compression ultrasound. Those with a normal result undergo clinical follow-up for thrombotic outcomes over the following three months.
Other: Whole-leg compression ultrasound
Duplex ultrasound assessment of the venous system of the leg(s) suspected of deep vein thrombosis. Assessment occurs from the most proximal assessable portion of the common femoral vein (usually at the inguinal ligament) to the level of the malleolus.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be suspected by the referring medical provider to have a first episode of acute DVT of the lower extremities.
  • Be presenting for the initial diagnostic ultrasound for the present symptom complex.
  • Pregnancy confirmed by an objective test.
  • Be > 18 years old.
  • Provide written informed consent.

Exclusion Criteria:

  • Compression ultrasonography cannot be performed due to physical or technical reasons.
  • The patient has a prior history of DVT in the ipsilateral leg.
  • Previous venous ultrasound has been performed during the same pregnancy.
  • The patient is suspected by the referring clinician to have symptomatic pulmonary embolism.
  • 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.
  • Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).
  • Informed consent cannot be obtained.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319474

Locations
United States, Utah
Intermoutain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Scott M Stevens, MD    801-507-3310    scott.stevens@imail.org   
Principal Investigator: Scott M Stevens, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Scott M Stevens, MD Intermountain Health Care, Inc.
  More Information

Publications:
Responsible Party: Scott M. Stevens, Transitional Year Program Director, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01319474     History of Changes
Other Study ID Numbers: 950359
Study First Received: March 17, 2011
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Deep vein thrombosis
Pulmonary embolism
Ultrasound
Pregnancy

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014