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Performance of a new, structured diagnostic algorithm for suspected pulmonary embolism in pregnant patients


- candidate number24529
- NTR NumberNTR5913
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2016
- Secondary IDsP13.151  
- Public TitlePerformance of a new, structured diagnostic algorithm for suspected pulmonary embolism in pregnant patients
- Scientific TitleAdvanced diagnostic management of suspected pulmonary embolism in pregnant patients n a multicenter multinational project
- ACRONYMThe Artemis study
- hypothesisTo evaluate the safety and efficiency of a new diagnostic strategy for pregnant patients with suspected pulmonary embolism
- Healt Condition(s) or Problem(s) studiedDiagnosis, Pulmonary embolism, Pregnancy
- Inclusion criteria- Pregnant patient with suspected (recurrent) pulmonary embolism
- age 18 years
- Exclusion criteria- treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin that was initiated 24 hours or more prior to eligibility assessment
- treatment with vitamin K antagonists (coumarin derivates)
- Ultrasonography proven symptomatic proximal DVT
- unable to give consent
- contraindication to helical CT because of allergy to intravenous iodinated contrast or renal insufficiency (creatinin clearance < 30 ml/min)
- impossibility to return for follow-up
- life expectancy < 3 months
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 16-sep-2013
- planned closingdate1-jul-2019
- Target number of participants400
- InterventionsProspective multicenter management study of consecutive pregnant patients with suspected (recurrent) PE. Participants will be evaluated according to the study algorithm consisting of three items of the original Wells rule (clinical signs DVT, hemoptysis, "PE most likely diagnosis") and a D-dimer test. In patients with clinical signs of DVT, a compression ultrasonography will be performed to rule out deep vein thrombosis. Patients with confirmed DVT are considered to have PE and anticoagulant treatment will be initiated. In the remaining patients without any of the three items and a D-dimer level < 1.0 g/ml, and in patients with ≥ 1 items and a D-dimer level < 0.5 g/ml PE is excluded without computed tomography pulmonary angiography (CTPA). In the other patients a CTPA will be performed. If PE is confirmed by CTPA, anticoagulant treatment will be initiated. If CTPA result is normal, PE is considered to be ruled out and anticoagulant therapy is withheld. All patients will be followed for a period of three months.
- Primary outcome(recurrent) PE, DVT, mortality
- Secondary outcomenumber of performed CTPAs
- Timepointsthe primary and secondary endpoints will be determined after three months follow-up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD L.M. van der Pol
- CONTACT for SCIENTIFIC QUERIESPhD L.M. van der Pol
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Brest University Hospital
- Publications-
- Brief summaryRationale: In non-pregnant patients, well established algorithms exist, including combination of clinical decision rule, D-dimer test and in case of a "likely" clinical decision rule or abnormal D-dimer test, computed tomography pulmonary angiography (CTPA) to rule out the diagnosis. This strategy is no option for pregnant patients since no validated pregnancy-specific clinical decision rules exist and D-dimer levels often rise physiologically in pregnancy. Current practice is to perform V-Q lung scan or CTPA as standalone test, but both have drawbacks. Recently, a new diagnosed algorithm for suspected PE was developed and validated (van Es et al, JTH 2015). We set out to evaluate the safety and efficiency of this algorithm in pregnant patients with suspected PE.

Objectives: 1) to validate the clinical utility and safety of the study algorithm by determining the three-months VTE incidence in pregnant patients in whom PE was excluded at baseline. 2) to assess the number of required CTPA and compare that to the numbers from historical cohorts. Design: Prospective multicenter management study of consecutive pregnant patients with suspected (recurrent) PE. Participants will be evaluated according to the study algorithm consisting of three items of the original Wells rule (clinical signs DVT, hemoptysis, "PE most likely diagnosis") and a D-dimer test. In patients with clinical signs of DVT, a compression ultrasonography will be performed to rule out deep vein thrombosis. Patients with confirmed DVT are considered to have PE and anticoagulant treatment will be initiated. In the remaining patients without any of the three items and a D-dimer level < 1.0 g/ml, and in patients with ≥ 1 items and a D-dimer level < 0.5 g/ml PE is excluded without CTPA. In the other patients a CTPA will be performed. If PE is confirmed by CTPA, anticoagulant treatment will be initiated. If CTPA result is normal, PE is considered to be ruled out and anticoagulant therapy is withheld. All patients will be followed for a period of three months.
- Main changes (audit trail)
- RECORD29-jun-2016 - 12-okt-2016


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