PregnancyLEaDNCT02507180
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
An observational study of Pregnancy and Deep Vein Thrombosis, run by Ottawa Hospital Research Institute at 12 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pregnancy, Deep Vein Thrombosis
- What is being tested?
- LEFt clinical decision rule
- How many people
- 366 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2015to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Unselected pregnant women presenting with suspected deep vein thrombosis
Who may be able to join
- Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with
- Suspected acute symptomatic deep vein thrombosis, defined as:
- New leg swelling or edema with onset in the last month or,
- New leg pain (buttock, groin, thigh or calf) with onset in the last month.
Who cannot join
- Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada)
- 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
- Unable or unwilling to provide informed consent
- Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)
- Therapeutic anticoagulant more than 48 hours.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Canada9 sites, 7 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Jessica Lee, BA
Alissa Kazakoff, BSc
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta
Shauna Littlefair, RN
Rshmi Khurana, MD
- Recruiting
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia
Blaine Gallant, RN
Sudeep Shivakumar, MD
- Recruiting
Hamilton Health Sciences Centre
Hamilton, Ontario
Carolyn Webb, RN
Shannon Bates, MD
- Withdrawn
London Health Sciences Centre
London, Ontario
- Recruiting
Jewish General Hospital
Montreal, Quebec
Carla Strulovitch, RN
Susam Kahn, MD
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario
Veronica Whitham, BSc
Marc Rodger, MD
- Withdrawn
Sunnybrook Medical Hospital
Toronto, Ontario
- Recruiting
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia
Frannie MacKenzie
Wee-Shian Chan, MD
United States1 site, 1 recruiting
- Not yet recruiting
Intermountain Healthcare, Inc.
Murray, Utah
Scott Stevens, MD
Scott Stevens, MD
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
Erik Klok, MD
Erik Klok, MD
Switzerland1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Geneve
Geneva
Louise Riberdy, MD
Marc Righini, MD
About this study
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.
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.
Read the 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.
- Conditions
- Pregnancy, Deep Vein Thrombosis
- Being tested
- LEFt clinical decision rule
- Keywords
- Clinical Decision Rule, Ultrasound, Suspected Deep Vein Thrombosis, D-Dimer, LEFt
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEFt clinical decision ruleOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: LEFt clinical decision rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of VTE diagnosed in patients deemed DVT "unlikely"
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
Measured: 3 months after presentation
Secondary outcomes (3)
Number of VTE diagnosed in all patients
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.
Measured: 3 months after presentation
Proportion of women requiring CUS
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.
Measured: Baseline
Average number of CUS in pregnant women with suspected DVT
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.
Measured: 7 days from initial presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Marc Rodger, MD, Principal investigator, Ottawa Hospital Research InstituteMarc Righini, MD, Principal investigator, Hopitaux Universitaires de Geneve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507180
- Sponsor's protocol ID
- 20150546-01H
- Acronym
- LEaD
- Status last verified
- Feb 2020
- First submitted
- 22 Jul 2015
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02507180
- Acronym / sponsor ID
- LEaD / 20150546-01H
- Conditions
- Pregnancy, Deep Vein Thrombosis
- Keywords
- Clinical Decision Rule, Ultrasound, Suspected Deep Vein Thrombosis, D-Dimer, LEFt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Leiden University Medical Center
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with suspected DVT | – | Other: LEFt clinical decision rulePregnant 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Unselected pregnant women presenting with suspected deep vein thrombosis
Key inclusion criteria (4 listed)
- Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with
- Suspected acute symptomatic deep vein thrombosis, defined as:
Key exclusion criteria (5 listed)
- Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada)
- 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
- Unable or unwilling to provide informed consent
- Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)
- Therapeutic anticoagulant more than 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEFt clinical decision ruleThe 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 | Other | Pregnant women with suspected DVT |
Primary outcome
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
3 secondary outcomes
Number of VTE diagnosed in all patients
Time frame: 3 months after presentation
Proportion of women requiring CUS
Time frame: Baseline
Average number of CUS in pregnant women with suspected DVT
Time frame: 7 days from initial presentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Rodger, MD principal investigator
Ottawa Hospital Research Institute
Marc Righini, MD principal investigator
Hopitaux Universitaires de Geneve
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Deep Vein Thrombosis, run by Ottawa Hospital Research Institute at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc A Rodger, MD (514-843-1578, marc.rodger@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of VTE diagnosed in patients deemed DVT "unlikely" (time frame: 3 months after presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.