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

Advanced diagnostic management of suspected pulmonary embolism in pregnant patients ¡n a multicenter multinational project

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28083
Enrollment
400
Registered
2016-06-29
Start date
2013-09-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Pulmonary embolism, pregnancy

Interventions

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 th
1 items and a D-dimer level < 0.5 µg/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, anticoagula

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Pregnant patient with suspected (recurrent) pulmonary embolism - age ¡Ý 18 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
(recurrent) PE, DVT, mortality

Secondary

MeasureTime frame
number of performed CTPAs

Contacts

Public ContactL.M. van der Pol

Department of Thrombosis and Haemostasis Leiden University Medical Cente

lm.vanderpol@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)