A trial to determine if withholding anticoagulation is not worse than standard anticoagulation therapy in the treatment of blood clots in the lungs

Not Applicable

• Conditions: Isolated or incidental subsegmental pulmonary embolism; Pulmonary embolism; Circulatory System

• Registration Number: ISRCTN15645679
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-23
• Last Update Posted: 17 October 2022
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 1466

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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