Recruiting

LEFt with D-Dimer

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02507180

Conditions

Pregnancy

Deep Vein Thrombosis

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

Interventions

LEFt clinical decision rule

Study Details

Brief summary:

This is prospective cohort study in pregnant women who present with signs and symptoms of possible deep vein thrombosis (DVT). All patients will have the same method of assessment of their DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.

Conditions

Pregnancy

Deep Vein Thrombosis

Study ID

NCT02507180

Start date

Sep, 2015

Status verified date

Feb, 2020

Completion date

Jan, 2022

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with
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:

1. Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada)
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.

Study Design

Enrollment

366 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Number of VTE diagnosed in patients deemed DVT "unlikely" [ Time Frame: 3 months after presentation ]

Central Contacts and Locations

Central contacts

Marc A Rodger, MD

514-843-1578marc.rodger@mcgill.ca

Veronica Bates, BSc

613-737-8899vebates@ohri.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Principal Investigator:

Paul Gibson, MD

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada

Principal Investigator:

Rshmi Khurana, MD

Children's and Women's Health Centre of British Columbia

Recruiting

Vancouver, British Columbia, Canada

Principal Investigator:

Wee-Shian Chan, MD

Queen Elizabeth II Health Science Centre

Recruiting

Halifax, Nova Scotia, Canada

Principal Investigator:

Sudeep Shivakumar, MD

Hamilton Health Sciences Centre

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Shannon Bates, MD

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

Marc Rodger, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Principal Investigator:

Susam Kahn, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 27, 2020

Last verified

Feb, 2020

Keywords

  • Clinical Decision Rule
  • Ultrasound
  • Suspected Deep Vein Thrombosis
  • D-Dimer
  • LEFt

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-02-27.