Status:
UNKNOWN
Low Dose Catheter Directed Thrombolysis for Acute Pulmonary Embolism
Lead Sponsor:
University of Aarhus
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
BETULA trial will compare the efficacy of low dose catheter directed thrombolysis (CDT) to unfractioned heparin (UFH) in patients with intermediary-high risk pulmonary embolism (PE). Patients (n=60) ...
Detailed Description
1. Aim To investigate if low dose catheter directed fibrinolysis for 2 hours is superior to unfractioned heparin with regards to unloading the right ventricle in acute intermediate-high risk pulmonary...
Eligibility Criteria
Inclusion
- Age \> 17 and \< 81 years
- Debut of symptoms \<14 days
- Acute symptomatic Intermediate-high risk pulmonary embolism (PE, according to 2014 European Society of Cardiology guidelines) confirmed by computed tomography angiography (CTA) with the embolus located in at least one proximal lower lobe or main pulmonary artery.
- Right-to-left ventricular dimension ratio \>1.0 on CTA or trans-thoracic echocardiography (TTE)
Exclusion
- Significant bleeding risk or other contraindications to catheter directed thrombolysis (CDT) or unfractionated heparin\*
- Not possible to perform CDT within 48 hours after diagnosis
- Pregnancy
- Cardiac arrest requiring cardiopulmonary resuscitation
- Life expectancy \< 120 days
- Altered mental status such that the patient is unable to provide informed consent
- Suspected or known chronic thromboembolic pulmonary hypertension
- Sustained hypertension (\>180 mmHg systolic and/or \>105 mmHg diastolic)
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03854266
Start Date
March 10 2020
End Date
March 10 2024
Last Update
April 28 2021
Active Locations (1)
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1
Aarhus University Hospital, Dep. Cardiology
Aarhus N, Denmark, 8200