Catheter-directed thrombolysis in patients with acute pulmonary embolism

Catheter-directed thrombolysis in patients with intermediate-high risk acute pulmonary embolism: a randomized pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22121045

Enrollment

Registered

2022-01-31

Start date

2019-11-01

Completion date

Unknown

Last updated

2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pulmonary embolism Circulatory System Pulmonary embolism

Interventions

Study participants with CT angiographically (CTA) verified acute pulmonary embolism are randomized using the envelope method into two groups - catheter-directed local thrombolysis (CDT group - interve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged >18 years 2. Computed tomography angiography (CTA)-verified proximal* PE and symptom onset 53 ng/l (men) or >34 ng/l (women); NT-proBNP level >600 pg/ml

Exclusion criteria

Exclusion criteria: 1. Active clinically significant bleeding 2. Any hemorrhagic stroke OR a recent (2.0, platelet count =100 x 10e9; creatinine level >200 µmol/l 8. Pregnant or breastfeeding, fertility without previous exclusion of gravidity 9. Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia 10. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
1. Effectiveness of CDT, defined as improved right ventricle function (at least two of the following criteria are met): 1.1. Reduction of the RV/LV ratio by 25% between admission and 48 h post-randomization, as revealed by CTA 1.2. Reduction of the systolic pulmonary artery pressure (sPAP) by 30% from baseline or attainment of normotension (=35 mmHg sPAP), as revealed by echocardiography at 24 h post-randomization 1.3. Reduction of the Qanadli score by 30% between admission and 48 h post-randomisation, as revealed by CTA 2. Safety of CDT, defined as the absence of intracranial or life-threatening bleeding according to the Bleeding Academic Research Consortium (BARC) classification (i.e., type 5 or 3c bleeding) within 72 h post-randomisation	—

Measure

Time frame

1. Effectiveness of CDT, defined as improved right ventricle function (at least two of the following criteria are met): 1.1. Reduction of the RV/LV ratio by 25% between admission and 48 h post-randomization, as revealed by CTA 1.2. Reduction of the systolic pulmonary artery pressure (sPAP) by 30% from baseline or attainment of normotension (=35 mmHg sPAP), as revealed by echocardiography at 24 h post-randomization 1.3. Reduction of the Qanadli score by 30% between admission and 48 h post-randomisation, as revealed by CTA 2. Safety of CDT, defined as the absence of intracranial or life-threatening bleeding according to the Bleeding Academic Research Consortium (BARC) classification (i.e., type 5 or 3c bleeding) within 72 h post-randomisation

—

Secondary

Measure	Time frame
1. Technical success of catheter-directed treatment, defined as successful catheter placement followed by continuous infusion of alteplase at the time of the procedure 2. All bleeding complications scored by Bleeding Academic Research Consortium classification during hospitalization 3. Hemodynamic instability, defined as cardiac arrest or persistent hypotension (systolic blood pressure 15 minutes, not caused by hypovolaemia, sepsis, or arrhythmia), recorded during hospitalization 4. Length of hospitalization collected from medical records during hospitalization 5. In-hospital mortality collected from medical records during hospitalization	—

Measure

Time frame

1. Technical success of catheter-directed treatment, defined as successful catheter placement followed by continuous infusion of alteplase at the time of the procedure 2. All bleeding complications scored by Bleeding Academic Research Consortium classification during hospitalization 3. Hemodynamic instability, defined as cardiac arrest or persistent hypotension (systolic blood pressure 15 minutes, not caused by hypovolaemia, sepsis, or arrhythmia), recorded during hospitalization 4. Length of hospitalization collected from medical records during hospitalization 5. In-hospital mortality collected from medical records during hospitalization

—

Countries

Czech Republic

Contacts

Public ContactJosef Kroupa

josef.kroupa@fnkv.cz+420 (0)267162701

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026