NL-OMON52149撤回不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •breathing room air;
- •4) Right-to-left ventricular (RV/LV) diameter ratio * 1.0 on CTPA
- •5) Serum troponin I or T levels above the upper limit of normal
- •6) Signed informed consent.
排除标准
- •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
- •low-dose catecholamines may be included, provided that they could be stabilized
- •within 2 hours of admission and maintain
- •2) Need for admission to an intensive care unit for a reason other than the
- •index PE episode. Note: Patients who test positive for severe acute respiratory
- •syndrome coronavirus 2 (SARS-CoV-2) can be enrolled where the investigator
- •believes that the pulmonary embolism is the dominant pathology in the patient*s
- •clinical presentation and qualifying cardiorespiratory parameters.
- •3) Temperature above 39oC / 102.2oF
- •4) Logistical reasons limiting the rapid availability of interventional
- •procedures to treat acute PE (e.g., during the outbreak of an epidemic)
- •5) Index PE symptom duration > 14 days
- •6) Active bleeding
- •7) History of intracranial or intraocular bleeding at any time
- •8) Stroke or transient ischemic attack within the past 6 months, or previous
- •stroke at any time if associated with permanent disability
- •9) Central nervous system neoplasm, or metastatic cancer
- •10) Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or
- •orthopedic surgery or trauma (including syncope-associated with head strike or
- •skeletal fracture) within the past 3 weeks
- •11) Platelet count < 100 x 109 x L-1
- •12) Patients who have received a once-daily therapeutic dose of LMWH or a
- •therapeutic dose of fondaparinux within 24 hours prior to randomization
- •13) Patients who have received one of the direct oral anticoagulants apixaban
- •or rivaroxaban within 12 hours prior to randomization
- •14) Patients who have received one of the direct oral anticoagulants dabigatran
- •or edoxaban for the index PE episode, as these drugs are not approved for
- •patients who have not received heparin for at least 5 days
- •15) Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor
- •antagonist during the current hospital stay and/or within 30 days, for any
- •16) Chronic treatment with antiplatelet agents other than low-dose
- •acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual
- •antiplatelet therapy is excluded.
- •17) Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran,
- •edoxaban or rivaroxaban)
- •18) Chronic treatment with a vitamin K antagonist, or known coagulopathy
- •including severe hepatic dysfunction, with an International Normalized Ratio
- •(INR) > 1.5
- •19) Pregnancy or lactation
- •20) Previous inclusion in the study
- •21) Known hypersensitivity to alteplase, LMWH or UFH, or to any of the
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