Whole-leg Ultrasound in Pregnant Patients (CLOT-3)
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.
|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|
- 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.
- 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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01319474
|United States, Utah|
|Intermoutain Medical Center||Recruiting|
|Murray, Utah, United States, 84157|
|Contact: Scott M Stevens, MD 801-507-3310 firstname.lastname@example.org|
|Principal Investigator: Scott M Stevens, MD|
|Principal Investigator:||Scott M Stevens, MD||Intermountain Health Care, Inc.|