Low Dose Catheter Directed Thrombolysis for Acute Pulmonary Embolism (BETULA)
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|ClinicalTrials.gov Identifier: NCT03854266|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 28, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Drug: Low dose alteplase Drug: Unfractionated heparin Device: Infusion catheter||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Low Dose Catheter Directed Thrombolysis for Acute Intermediary-high Risk Pulmonary Embolism|
|Actual Study Start Date :||March 10, 2020|
|Estimated Primary Completion Date :||March 10, 2023|
|Estimated Study Completion Date :||March 10, 2024|
Experimental: Catheter directed thrombolysis
Low dose alteplase (4/8 milligram) will be infused over 2 hours locally in the pulmonary arteries at the site of the thrombus through an infusion catheter with sideholes (Unifuse, AngioDynamics, US)
Drug: Low dose alteplase
Low dose alteplase is 4 milligram per pulmonary artery (maximum dose 8 milligram) infused in the pulmonary arteries over 2 hours
Other Name: alteplase
Device: Infusion catheter
A sidehole catheter (Unifuse, AngioDynamics, US) catheter will be advanced to the pulmonary arteries to facilitate the catheter directed thrombolysis
Other Name: Unifuse
Active Comparator: Unfractionated heparin
Initial dose of unfractionated heparin is 80 international units per kilo (IU/kg) bolus followed by 18 IU/kg as continuous infusion with dose adjustment every 6 hours and once daily when activated partial thromboplastin time is 1.5-2.3 times control value.
Drug: Unfractionated heparin
Unfractioned heparin is administered in a peripheral vein with an initial dose of 80 international units per kilo (IU/kg) bolus followed by 18 IU/kg as continuous infusion with dose adjustment every 6 hours and once daily when activated partial thromboplastin time (APPT) is 1.5-2.3 times control value.
Other Name: heparin
- Right ventricle divided by left ventricular diameter (RV/LV ratio) [ Time Frame: 24 hours after intervention ]Measured on ECG gated contrast enhanced computed tomography
- Reduction in thrombus burden [ Time Frame: 24 hours after intervention ]A modified miller index till be measured on ECG gated contrast enhanced computed tomography
- Thirty day mortality [ Time Frame: 30 days after intervention ]The number of patients that are decease within 30 days after the intervention will be assessed from the patient files.
- Length of hospital stay [ Time Frame: 3 months after intervention ]The length of hospital stay in days will be evaluated from the patient files
- Recurrent pulmonary embolism [ Time Frame: 3 months after intervention ]Number of patients with recurrent pulmonary embolism will be evaluated from the patient files
- Lung perfusion [ Time Frame: 24 hours after intervention ]Lung perfusion will be evaluated and quantified with dual energy computed tomography
- Minor and major bleeding [ Time Frame: 24 hours after intervention ]Bleeding events will be recorded during the hospital stay during the daily rounds
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854266
|Contact: Asger Andersen, MD, PhDemail@example.com|
|Contact: Jens Erik Nielsen-Kudsk, MD, dMScfirstname.lastname@example.org|
|Principal Investigator:||Asger Andersen, MD, PhD||Aarhus University Hospital|