Isolated or incidental subsegmental pulmonary embolism Circulatory System Pulmonary embolism
Conditions
Interventions
The design is a prospective randomised open blinded end point (PROBE) trial, with individual level randomisation. The researchers have used an open design because of the importance of understanding ho
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Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. SSPE diagnosed by the radiologist at the trial site by CTPA or CT thorax with IV contrast 3. No evidence of proximal deep vein thrombosis on doppler ultrasonography or CT/MR venography 4. Heart rate <110 bpm 5. Systolic blood pressure =100 mmHg 6. Oxygen saturation =90% 7. Written signed informed consent to the trial
Exclusion criteria
Exclusion criteria: 1. Indication for hospital admission 2. >7 days empirical anticoagulation treatment immediately prior to randomisation 3. <28 days since first symptoms of proven or clinically suspected COVID-19 4. Known stage 5 chronic kidney disease 5. Patients with active cancer defined as cancer diagnosed within the past 6 months, cancer for which anticancer treatment was being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer 6. Patients with previous unprovoked PE, thrombophilia or requiring long term anticoagulation for another reason 7. Patients with a DVT / thrombus of an unusual site (e.g. upper limbs, associated with a line) that requires anticoagulation 8. Patients with active bleeding 9. Any condition which, in the opinion of the investigator, makes the participant unsuitable for trial entry due to prognosis/terminal illness with a projected survival of less than 3 months 10. Pregnancy confirmed by positive pregnancy test or post-partum period or actively trying to conceive 11. Inability to comply with the trial schedule and follow-up 12. Participation in a CTIMP study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent venous thromboembolism (VTE), death-related VTE, or clinically relevant bleeding, assessed using case report forms at the 12 and 24 week follow up timepoints | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in recurrent VTE and bleedings event assessed using case report forms at the 12, 24 and 52-week timepoints 2. Reclassification rate of SSPE diagnoses made by acute reporting radiologists when reviewed by thoracic radiologists, recorded on a case report form at registration/randomisation 3. Healthcare resource use: hospitalisations, bed days, unscheduled primary and secondary care visits for recurrent VTE, clinically relevant bleeding or potentially related symptoms, measured using case report forms at the 12, 24 and 52-week timepoints 4. Healthcare costs assessed using case report forms at the 12, 24 and 52-week timepoints 5. Health-related quality of life measured using the EQ-5D-5L questionnaire at baseline, 12 and 24 weeks 6. Cost-utility (cost per QALY) measured using a case report form at 24 weeks and cost-effectiveness (cost per VTE avoided) measured at 52 weeks 5. Acceptability to patients and clinicians and health-seeking behaviours and health utilisation of a no anticoagulation treatment strategy for isolated SSPE, assessed through audio-recorded interviews which can occur at any point throughout the trial | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed