Overview

Low Dose Catheter Directed Thrombolysis for Acute Pulmonary Embolism

Status:
Recruiting
Trial end date:
2024-03-10
Target enrollment:
0
Participant gender:
All
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) with acute intermediary-high risk PE will be randomized 1:1 to UFH (bolus 80 international units per kilo (IU/kg)) followed by 18 IU/kg/hour until activated partial thromboplastin time (APTT) is 2-2.5 of reference value) or CDT (4mg alteplase (r-tPA) per catheter, infusion over 2 hours) in an open label, outcome assessor blinded, randomized, controlled trial. Primary efficacy endpoint is improvement in right-/left ventricular ratio 24 hours after randomization. Secondary endpoints are 30 days mortality, recurrent PE, length of hospital stay and reduction in thrombus burden evaluated by pulmonary CT angio. Safety endpoints are minor and major bleedings.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Aarhus
Treatments:
Calcium heparin
Heparin
Thromboplastin
Tissue Plasminogen Activator
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)