A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk embolism thrombolysis study

• Conditions: Pulmonary embolism; blood clot in lung; 10037454

• Registration Number: NL-OMON51732
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 45

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
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

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
low-dose
catecholamines may be included, provided that they could be stabilized within 2
hours
of admission and maintain SBP of >= 90 mmHg and adequate organ perfusion without
catecholamine infusion.
2) Need for admission to an intensive care unit for a reason other than the
index PE episode.
Note: Patients who test positive for 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 reason
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, UFH, or to any of the excipients
22) Life expectancy less than 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified