Low Dose Catheter Directed Thrombolysis for Acute Pulmonary Embolism
Status:
Recruiting
Trial end date:
2024-03-10
Target enrollment:
Participant gender:
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.