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Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer (LEaD)

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ClinicalTrials.gov Identifier: NCT02507180
Recruitment Status : Unknown
Verified February 2020 by Ottawa Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : July 23, 2015
Last Update Posted : February 27, 2020
Sponsor:
Collaborators:
University Hospital, Geneva
Leiden University Medical Center
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date July 22, 2015
First Posted Date July 23, 2015
Last Update Posted Date February 27, 2020
Actual Study Start Date September 2015
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2019)
Number of VTE diagnosed in patients deemed DVT "unlikely" [ Time Frame: 3 months after presentation ]
The primary outcome will be the number of VTE (distal or proximal DVT, sub-segmental or greater pulmonary embolism (PE), death attributable to VTE) documented during the three-month follow-up in those patients left untreated for DVT on the basis of the study's initial diagnostic management (see Figure 2) i.e. not doing CUS on patients with an "unlikely" LEFt score (0 or 1 points) and a negative D-dimer
Original Primary Outcome Measures
 (submitted: July 22, 2015)
Number of VTE, in patients deemed DVT "unlikely" [ Time Frame: 3 months after presentation ]
The primary outcome will be the number of VTE (any DVT (distal or proximal), PE (sub-segmental or greater PE), death attributable to VTE) documented during the three-month follow-up in those patients left untreated for DVT on the basis of the study's initial diagnostic management (see Figure 2) i.e. not doing CUS on patients with an "unlikely" LEFt score (0 or 1 points) and a negative D-dimer
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2019)
  • Number of VTE diagnosed in all patients [ Time Frame: 3 months after presentation ]
    The number of major VTE events (any proximal DVT, segmental or greater PE, death attributable to VTE) documented during the 3-month follow-up in all patients. Some clinicians may not treat distal DVT or sub-segmental PE in pregnancy, instead following these patients with serial US imaging, and hence may prefer to focus on this outcome that excludes distal DVT and sub-segmental PE.
  • Proportion of women requiring CUS [ Time Frame: Baseline ]
    The proportion of women requiring CUS using the study's diagnostic strategy (i.e. no imaging in patients with an "unlikely" LEFt score (0 or 1 points) and a negative D-dimer). We anticipate that an important proportion (>40%) of women will be able to avoid the need for CUS imaging based on safely excluding DVT on the basis of an "unlikely" LEFt (0 or 1) and a negative D-dimer. However, if this proportion is very low (<5%) this may argue against the widespread adoption of our proposed diagnostic management strategy even if it proves to be safe.
  • Average number of CUS in pregnant women with suspected DVT [ Time Frame: 7 days from initial presentation ]
    The mean number of ultrasounds per patient with suspected DVT. In the study by Chan, validating serial CUS in pregnancy, the mean number of US per patient was 2.8630. We anticipate that we will be able to reduce this by >40% with our diagnostic approach.
Original Secondary Outcome Measures
 (submitted: July 22, 2015)
  • Number of VTE, in all patients [ Time Frame: 3 months after presentation ]
    The number of major VTE events (any proximal DVT, segmental or greater PE, death attributable to VTE) documented during the 3-month follow-up in the patients. Some clinicians may not treat distal DVT or sub-segmental PE in pregnancy, instead following these patients with serial US imaging, and hence may prefer to focus on this outcome that excludes distal DVT and sub-segmental PE.
  • Proportion of women requiring CUS [ Time Frame: Baseline ]
    The proportion of women requiring CUS using the study's diagnostic strategy (i.e. no imaging in patients with an "unlikely" LEFt score (0 or 1 points) and a negative D-dimer). We anticipate that an important proportion (>40%) of women will be able to avoid the need for CUS imaging based on safely excluding DVT on the basis of an "unlikely" LEFt (0 or 1) and a negative D-dimer. However, if this proportion is very low (<5%) this may argue against the widespread adoption of our proposed diagnostic management strategy even if it proves to be safe.
  • Average number of CUS in pregnant women with suspected DVT [ Time Frame: 7 days from initial presentation ]
    The mean number of ultrasounds per patient with suspected DVT. In the study by Chan, validating serial CUS in pregnancy, the mean number of US per patient was 2.8630. We anticipate that we will be able to reduce this by >40% with our diagnostic approach.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Official Title Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer: the LEaD Study. A Prospective Cohort Study.
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.
Detailed Description

VTE is a leading cause of maternal death in the developed world. Suspected DVT in pregnancy is a common clinical problem faced by clinicians daily. The only validated method to exclude DVT in pregnancy requires leg vein CUS imaging. This imaging modality is costly and has limited availability (only available in radiology departments and, usually, only during weekday daytime hours) often necessitating referral to the emergency room for initiation of heparin injections until leg vein CUS can be obtained. A simple and seemingly powerful clinical decision rule (LEFt) and a simple blood test (D-dimer) may be promising to exclude DVT in pregnancy without the need for diagnostic imaging. Validating the safety of a simple, non-invasive, widely available approach to suspected DVT in pregnancy would be an important advance in maternal health.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
At presentation, a blood sample will be collected for clinical D-dimer tested in real time and a sample will be collected and the plasma will be frozen for analysis at the end of study using Vidas D-dimer on all patient samples.
Sampling Method Probability Sample
Study Population Unselected pregnant women presenting with suspected deep vein thrombosis
Condition
  • Pregnancy
  • Deep Vein Thrombosis
Intervention Other: 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

Study Groups/Cohorts 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.
Intervention: Other: LEFt clinical decision rule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 22, 2015)
366
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Netherlands,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02507180
Other Study ID Numbers 20150546-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Ottawa Hospital Research Institute
Original Responsible Party Same as current
Current Study Sponsor Ottawa Hospital Research Institute
Original Study Sponsor Same as current
Collaborators
  • University Hospital, Geneva
  • Leiden University Medical Center
Investigators
Principal Investigator: Marc Rodger, MD Ottawa Hospital Research Institute
Principal Investigator: Marc Righini, MD Hopitaux Universitaires de Geneve
PRS Account Ottawa Hospital Research Institute
Verification Date February 2020