NL-OMON56449
Not yet recruiting
Phase 3
Pulmonary Embolism International Thrombolysis Trial: A reduced dose of thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism: a randomized controlled trial. - PEITHO-3
Assistance Publique - Hôpitaux de Paris, Clinical Research and Innovation Direction (DRCI)0 sites75 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Assistance Publique - Hôpitaux de Paris, Clinical Research and Innovation Direction (DRCI)
- Enrollment
- 75
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older;
- •\* Objectively confirmed acute PE with first symptoms occurring 2 weeks or less
- •before randomization. Objective confirmation is based on at least one of the
- •following criteria: (a) at least one segmental ventilation\-perfusion mismatch
- •on lung scanning; (b) computed tomography pulmonary angiography (CTPA) or
- •selective pulmonary angiography showing a filling defect or an abrupt
- •obstruction of a segmental or more proximal pulmonary artery;
- •\* \*cute PE confirmed within 24 hours prior to randomization;
- •\* Elevated risk of early death, or of hemodynamic collapse, or PE recurrence,
- •indicated by at least one of the following criteria: (a) systolic blood
Exclusion Criteria
- •\* Hemodynamic instability, defined by at least one of the following criteria
- •\- cardiac arrest;
- •\- obstructive shock, defined as: (i) SBP \< 90 mm Hg, or vasopressors required
- •to achieve a SBP \>\= 90 mmHg despite an adequate filling status; and (ii)
- •end\-organ hypoperfusion (altered mental status; cold, clammy skin;
- •oliguria/anuria; increased serum lactate);
- •\- isolated persistent hypotension (SBP \< 90 mm Hg, or a systolic pressure drop
- •\>\= 40 mm Hg for \> 15 min), if not caused by new\-onset arrhythmia, hypovolemia,
- •\* Active bleeding
- •\* History of non\-traumatic intracranial bleeding, any time
Outcomes
Primary Outcomes
Not specified
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