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A simplified diagnostic algorithm for suspected pulmonary embolism


- candidate number15490
- NTR NumberNTR4193
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2013
- Secondary IDsP13.151 
- Public TitleA simplified diagnostic algorithm for suspected pulmonary embolism
- Scientific TitleA simplified diagnostic algorithm for patients with clinically suspected acute pulmonary embolism
- ACRONYMN/A
- hypothesisTo evaluate the safety and efficiency of a new diagnostic strategy for patients with suspected pulmonary embolism
- Healt Condition(s) or Problem(s) studiedDiagnosis, Pulmonary embolism
- Inclusion criteriaConsecutive patients with suspected (recurrent) PE.
- Exclusion criteria-life expectancy <3 months
- 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)
- contraindication to helical CT.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 7-okt-2013
- planned closingdate7-okt-2016
- Target number of participants3260
- InterventionsA prospective multi-center management registration of consecutive patients with suspected (recurrent) PE. Participants will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, hemoptysis, ‘PE most likely diagnosis’) and a D-dimer test. In patients without any of the three items and a D-dimer level <1.0 μg/mL, and in patients with ≥1 items and a D-dimer level <0.5 μg/mL a PE is excluded without CTPA. In the other patients a CTPA will be performed. All patients will be followed for a period of 3 months.
- Primary outcome(recurrent) PE, DVT
- Secondary outcomemortality, number of performed CTPA.
- TimepointsFollow-up duration: the primary and secondary endpoints will be determined after 3 months follow-up.
- Trial web sitewww.msbi.nl/years
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Tom Hulle, van der
- CONTACT for SCIENTIFIC QUERIESMD Tom Hulle, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryRationale: Current diagnostic algorithms for pulmonary embolism (PE) still result in a high number of negative computed tomography pulmonary angiography (CTPA) scans. In addition, they are relatively complex resulting in low application in clinical practice outside clinical studies. Recently, a post-hoc study demonstrated a safe, simplified and more efficient diagnostic strategy. With this registry, we aim to evaluate this strategy prospectively.

Objectives: 1) to evaluate the clinical utility and safety of the YEARS algorithm; 2) to assess the percentage of patients in whom a CTPA was required.

Design: A prospective multi-center registry of consecutive patients with suspected (recurrent) PE. Participants will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, hemoptysis, ‘PE most likely diagnosis’) and a D-dimer test. In patients without any of the three items and a D-dimer level <1.0 μg/mL, and in patients with ≥1 items and a D-dimer level <0.5 μg/mL a PE is excluded without CTPA. In the other patients a CTPA will be performed. All patients will be followed for a period of 3 months.
- Main changes (audit trail)
- RECORD1-okt-2013 - 14-okt-2013


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