Whole-leg Ultrasound in Pregnant Patients

NCT01319474 | Unknown

• 1 other identifier: 950359
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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

Keywords

Deep vein thrombosis; Pulmonary embolism; Ultrasound; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Symptomatic VTE

  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.

  Three months

Secondary Outcomes (1)

• Isolated iliac DVT

  At enrollment

Study Arms (1)

Ultrasound for suspected DVT

OTHER

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

Interventions

Whole-leg compression ultrasound OTHER

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.

Ultrasound for suspected DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermoutain Medical Center

Murray, Utah, 84157, United States

RECRUITING

Related Publications (4)

• Wells PS, Anderson DR. Modern approach to diagnosis in patients with suspected deep vein thrombosis. Haemostasis. 1999 Dec;29 Suppl S1:10-20. doi: 10.1159/000054107.

  PMID: 10629399 BACKGROUND

• Chan WS, Lee A, Spencer FA, Crowther M, Rodger M, Ramsay T, Ginsberg JS. Predicting deep venous thrombosis in pregnancy: out in "LEFt" field? Ann Intern Med. 2009 Jul 21;151(2):85-92. doi: 10.7326/0003-4819-151-2-200907210-00004.

  PMID: 19620161 BACKGROUND

• 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: 15197015 BACKGROUND

• Johnson SA, Stevens SM, Woller SC, Lake E, Donadini M, Cheng J, Labarere J, Douketis JD. Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA. 2010 Feb 3;303(5):438-45. doi: 10.1001/jama.2010.43.

  PMID: 20124539 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Scott M Stevens, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston, MBA, RT

CONTACT

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

Scott Stevens, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transitional Year Program Director

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 21, 2011
• Study Start: February 1, 2011
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)