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Early Catheter-directed Treatment of High Risk Pulmonary Embolism

RecruitingNAAges 18 Years - anyAllLeipzig Heart Science gGmbH
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In plain words

What the trial is, and whether it could suit you

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines: a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \<90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan 2. Age ≥18 years Exclusion Criteria: 1. Contraindications for catheter-based treatment 2. Contraindications to systemic fibrinolytic treatment or anticoagulation\* 1. Active, potentially life-threatening bleeding 2. Surgery within 24h before screening 3. Cranial or spinal surgery within 14d before screening 4. Stroke within 14d before screening 5. Intracranial tumor 6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator 3. Pregnancy * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
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What it tests

  • Early Catheter-Interventional Treatment
  • Conventional care
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Where

18 sites
Universitätsklinikum Freiburg
Bad Krozingen, Germany
Oberlausitzklinikum Bautzen, Medizinische Klinik I
Bautzen, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Frankfurt am Main, Germany
Universitätsklinikum Halle
Halle, Germany
Asklepios Klinik St. Georg
Hamburg, Germany

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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