Status:
COMPLETED
PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Stroke
Vascular Accident
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Stroke-associated pneumonia (SAP) is a grave complication of stroke and one of the most important predictors for patients' poor outcomes. Stroke associated pneumoniaSAP and other infections limited th...
Detailed Description
This study will enroll 168 intracerebral hemorrhage patients who meet the inclusion criteria. ICH patients meet the inclusion criteria will be randomly assigned at a 1:1 ratio into groups of standard...
Eligibility Criteria
Inclusion
- Age 18 years older and less than 80 years.
- Onset of new neurological deficits within≤24 hours at the time of randomization
- CT scan demonstrates supratentorial parenchymal hemorrhage and volume of hematoma≥10ml .
- Initial NIHSS score of 11 or greater and less than 25 scores.
- Initial GCS score (aggregate of verbal, eye, and motor response scores) of 8 or greater at time of enrollment.
- Admission without infection signs.
- Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Exclusion
- Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service, including surgical evacuation of hematoma, decompressive craniectomy, minimally invasive aspiration of hematoma, and ventricular shunt or external ventricular drainage for intracerebral hemorrhage into the ventricle.
- Patients with primary intraventricular hemorrhage or cerebral hemorrhage due to a definite cause, such as trauma, vascular malformation, aneurysm, coagulopathy, anticoagulant or antiplatelet drugs, thrombolytic therapy, post-infarction hemorrhagic transformation, hematologic disease, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, vasculitis, etc.
- Previous stroke or pre-onset motor disability (mRS≥1)
- Pregnancy or parturition within previous 30 days or active lactation.
- Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, etc.) or reserpine within the last 30 days.
- Bronchial asthma or chronic obstructive pulmonary disease
- Cardiogenic shock or severe or acute heart failure.
- Degree II-III atrioventricular block or sinus bradycardia or heart rate ≤65/min.
- Known sensitivity to propranolol.
- Severe hepatic or renal insufficiency
- History of Malignancy
- Currently participating in other interventional clinical trials.
- Immunosuppressant therapy or known immunosuppression.
Key Trial Info
Start Date :
February 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05419193
Start Date
February 21 2023
End Date
March 11 2025
Last Update
July 14 2025
Active Locations (12)
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1
Lu'an Hospital of Traditional Chinese Medicine
Lu'an, Anhui, China
2
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070
3
Third Affiliated Hospital, Soochow University
Changzhou, Jiangsu, China, 213003
4
Weinan City Center hospital
Weinan, Shaanxi, China