NL-OMON52149
Withdrawn
Not Applicable
A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis study - S2479 - Hi-PEITHO
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary embolism
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 45
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age 18\-80 years, inclusive
- •2\) Objectively confirmed acute PE, based on CTPA showing a filling defect in at
- •least one main or proximal lobar pulmonary artery (PA)
- •3\) Elevated risk of early death/hemodynamic collapse, indicated by at least two
- •of the following new\-onset clinical criteria:
- •i. Electrocardiogram (ECG)\-documented tachycardia with heart rate \*100 beats
- •per minute, not due to hypovolemia, arrhythmia, or sepsis;
- •ii. SBP \* 110 mm Hg for at least 15 minutes;
- •iii. respiratory rate \> 20 x min\-1 or oxygen saturation on pulse oximetry
- •(SpO2\) \< 90% (or partial arterial oxygen pressure \< 60 mmHg) at rest while
Exclusion Criteria
- •1\) Hemodynamic instability\*, i.e. at least one of the following present:
- •a) cardiac arrest or need for cardiopulmonary resuscitation;
- •b) need for ECMO, or ECMO initiated before randomization
- •c) PE\-related shock, defined as: (i) SBP \< 90 mmHg, or vasopressors required to
- •achieve SBP \* 90 mmHg, despite an adequate volume status; and (ii) end\-organ
- •hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate);
- •d) isolated persistent hypotension (SBP \< 90 mmHg, or a systolic pressure drop
- •by at least 40 mmHg for at least 15 minutes), not caused by new\-onset
- •arrhythmia, hypovolemia, or sepsis
- •\* Patients who presented with temporary need for fluid resuscitation and/or
Outcomes
Primary Outcomes
Not specified
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