ISRCTN15645679Terminated未知
STOPping Anticoagulation for isolated or incidental subsegmental Pulmonary Embolism
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Sponsor
- niversity of Birmingham
- Enrollment
- 1,466
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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