Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
NCT ID: NCT02507180
Last Updated: 2020-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
366 participants
OBSERVATIONAL
2015-09-30
2022-01-31
Brief Summary
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Detailed Description
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A prospective cohort diagnostic management study in pregnant women with suspected DVT, with three-month follow-up for symptomatic VTE will take place in multiple centres throughout Canada and Europe.
After obtaining informed consent, all patient will have the LEFt clinical decision rule applied by the attending physician and will have D-Dimer testing (D-Dimer results of test performed within 24 hours will be accepted and do not need to be repeated).
Patients with an "unlikely" LEFt score of 0 or 1 point and a negative D-dimer will not undergo diagnostic imaging.
Patients with either a "likely" LEFt score of 2 or 3 points or a positive D-dimer will undergo either a single complete leg vein compression ultrasound (CCUS) (Day 1) or a serial proximal leg vein (CUS) (Day 1 and Day 7).
All patients will be followed for 3 months for symptomatic VTE.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women with suspected DVT
Pregnant women presenting with suspected DVT will have the LEFt clinical decision rule applied by the attending physician and will have a clinical D-dimer test done.
LEFt clinical decision rule
The LEFt rule
Predictor Points Left leg symptoms +1 Extremity swelling (≥ 2 cm difference in calf circumference +1 First trimester symptom onset +1
Clinical probability Unlikely: 0 or 1 point Likely: \> 1 point
Interventions
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LEFt clinical decision rule
The LEFt rule
Predictor Points Left leg symptoms +1 Extremity swelling (≥ 2 cm difference in calf circumference +1 First trimester symptom onset +1
Clinical probability Unlikely: 0 or 1 point Likely: \> 1 point
Eligibility Criteria
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Inclusion Criteria
2. Suspected acute symptomatic deep vein thrombosis, defined as:
1. New leg swelling or edema with onset in the last month or,
2. New leg pain (buttock, groin, thigh or calf) with onset in the last month.
Exclusion Criteria
2. Baseline imaging (imaging done after a minimum of 3 months of treatment for prior proximal DVT) not available if suspected recurrence in the same leg as prior
3. Unable or unwilling to provide informed consent
4. Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)
5. Therapeutic anticoagulant more than 48 hours.
16 Years
FEMALE
No
Sponsors
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University Hospital, Geneva
OTHER
Leiden University Medical Center
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Marc Rodger, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Marc Righini, MD
Role: PRINCIPAL_INVESTIGATOR
Hopitaux Universitaires de Geneve
Locations
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Intermountain Healthcare, Inc.
Murray, Utah, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Medical Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Leiden University Medical Center
Leiden, , Netherlands
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Scott Stevens, MD
Role: primary
Jessica Lee, BA
Role: primary
Alissa Kazakoff, BSc
Role: backup
Shauna Littlefair, RN
Role: primary
Frannie MacKenzie
Role: primary
Blaine Gallant, RN
Role: primary
Carolyn Webb, RN
Role: primary
Veronica Whitham, BSc
Role: primary
Carla Strulovitch, RN
Role: primary
Erik Klok, MD
Role: primary
Louise Riberdy, MD
Role: primary
Other Identifiers
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20150546-01H
Identifier Type: -
Identifier Source: org_study_id
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