An observational study to determine the clinical characteristics in children unlikely to have a pulmonary embolism
No study has been performed to prospectively record the presenting complaints, signs, symptoms and comorbidities of children who raised the suspicion of pulmonary embolism (PE). Clinicians must extrapolate what is known about PE in adults to children. Perhaps as a result, the mortality rate of PE is the same in children as it is in adults. On the other hand, tens of thousands of low risk children and adolescents are unnecessarily exposed to increased lifetime cancer risk from ionizing radiation from CT scans done to search for PE they do not have. No clinical criteria have been developed to either estimate the probability of PE in children, or to exclude PE based upon information available at the bedside. This project will also identify which factors increase or decrease the probability of PE in children who raise a suspicion of PE, and may provide a much-needed evidence for physicians to have a rational basis to launch a workup for PE, and also provide clinical criteria to exclude PE without the need for ionizing radiation.
Study phase: Other
Study phase (if other): Phase 0
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Eligible subjects will be identi ed by on-site study staff. Inclusion criteria are:
1. Age 4-17 years; AND
2. Diagnostic test ordered for suspected pulmonary embolism:
a. D-dimer; or
b. CT scan; or
c. VQ scan; or
d. MRA or other pulmonary vascular imaging study; or
e. Diagnostic test for pulmonary embolism strongly considered but not ordered or cancelled
Primary disease category: Asthma & Lung
This study is enrolling healthy volunteers.
Sponsor: National Heart, Lung, Blood Institute (NHLBI)
Protocol number: 00133786; BEEPER
Projected enrollment dates: October 2020 to October 2024
Official study title: PECARN 048 (cIRB): BEdside Exclusion of Pulmonary Embolism in children without Radiation (BEEPER) Study