Status:
ACTIVE_NOT_RECRUITING
Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Herlev and Gentofte Hospital
University Hospital Bispebjerg and Frederiksberg
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism
Detailed Description
Trial acronym: STRATIFY Background: Intermediate-high risk pulmonary embolism (PE) is associated with a significant risk of death or hemodynamic deterioration. The optimal treatment strategy should ba...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Informed consent for trial participation
- Intermediate high-risk PE according to ESC criteria
- Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
- 14 days of symptoms or less
Exclusion
- Altered mental state (GCS \< 14)
- No qualifying CT angiography performed (\> 24 hour since CT angiography)
- Females of child bearing potential, unless negative HCG test is present
- Thrombolysis for PE within 14 days of randomization
- Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
- Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
- Comorbidity making 6 months survival unlikely
- Absolute contraindications for thrombolysis
- Hemorrhagic stroke or stroke of unknown origin at any time
- Ischemic stroke in the preceding 6 months
- Central nervous system damage or neoplasms
- Recent major trauma/surgery/head injury in the preceding 3 weeks
- Gastrointestinal bleeding within the last month
- Known bleeding risk
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04088292
Start Date
June 6 2019
End Date
November 30 2024
Last Update
November 15 2024
Active Locations (4)
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1
Copenhagen University Hospital Gentofte
Gentofte Municipality, Capital Region, Denmark, 2900
2
Copenhagen University Hospital Bispebjerg Hospital
Bispebjerg, Denmark, DK2400
3
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, DK2100
4
Copenhagen University Hospital, Herlev Gentofte Hospital
Herlev, Denmark, DK2730