Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism

• Status: Unknown status
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Copenhagen University Hospital, Hvidovre; Herlev and Gentofte Hospital; Hillerod Hospital, Denmark; University Hospital Bispebjerg and Frederiksberg
• Treatments: Calcium heparin; Heparin; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Informed consent for trial participation

3. Intermediate high-risk PE according to ESC criteria

4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography

5. 14 days of symptoms or less

Exclusion Criteria:

1. Altered mental state (GCS < 14)

2. No qualifying CT angiography performed (> 24 hour since CT angiography)

3. Females of child bearing potential, unless negative HCG test is present

4. Thrombolysis for PE within 14 days of randomization

5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)

6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)

7. Comorbidity making 6 months survival unlikely

8. Absolute contraindications for thrombolysis

1. Hemorrhagic stroke or stroke of unknown origin at any time

2. Ischemic stroke in the preceding 6 months

3. Central nervous system damage or neoplasms

4. Recent major trauma/surgery/head injury in the preceding 3 weeks

5. Gastrointestinal bleeding within the last month

6. Known bleeding risk