Recruiting

Observational Study

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT01319474

Conditions

Deep Vein Thrombosis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole-leg compression ultrasound

Study Details

Brief summary:

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.

Conditions

Deep Vein Thrombosis

Study ID

NCT01319474

Start date

Feb, 2011

Status verified date

Aug, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Jul 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

268 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

  • Symptomatic VTE [ Time Frame: Three months ]

Central Contacts and Locations

Central contacts

Valerie Aston, MBA, RT

(801) 507-4606valerie.aston@imail.org

Scott Stevens, MD

(801) 507- 3747Scott.Stevens@imail.org

Locations

Intermoutain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Scott M Stevens, MD

801-507-3310scott.stevens@imail.org

Principal Investigator:

Scott M Stevens, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Aug 7, 2019

Last verified

Aug, 2019

Keywords

  • Deep vein thrombosis
  • Pulmonary embolism
  • Ultrasound
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2019-08-07.