PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)

Capital Medical University

Status and phase: Enrolling; Phase 2

Conditions: Stroke; Vascular Accident; Hemorrhagic Stroke; Intracranial Hemorrhages; Stroke, Acute; Intracerebral Hemorrhage

Treatments: Drug: Propranolol Hydrochloride; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05419193

KY-2022-05-07-001

Details and patient eligibility

About

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 the overall efficacy of stroke management. Increasing evidence suggests that sympathetic nervous system activity contributes to post post-stroke immunosuppression and emergence of infections. This study is designed to test the safety and efficacy of an adrenergic β receptor blocker propranolol in reducing SAP in hemorrhagic stroke patients, in a multi-center, randomized, open-labeled, end point-blinded, trial.

Full 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 treatment (blank-controlled), or propranolol hydrochloride injection .

Patients allocated to experimented group will be intravenously given initial dose at 5mg propranolol hydrochloride daily over a course of 7 consecutive days, The primary purpose of this study is to compare propranolol hydrochloride with standard treatment on reducing the 7-day risk of pneumonia when initiated within 24 hours of symptom onset in intracerebral hemorrhage.

Both intent analysis (ITT) and per-protocol (PP) were used for analysis.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years older and less than 80 years.
2. Onset of new neurological deficits within≤24 hours at the time of randomization
3. CT scan demonstrates supratentorial parenchymal hemorrhage and volume of hematoma≥10ml .
4. Initial NIHSS score of 11 or greater and less than 25 scores.
5. Initial GCS score (aggregate of verbal, eye, and motor response scores) of 8 or greater at time of enrollment.
6. Admission without infection signs.
7. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

Exclusion criteria

1. 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.
2. 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.
3. Previous stroke or pre-onset motor disability (mRS≥1)
4. Pregnancy or parturition within previous 30 days or active lactation.
5. Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, etc.) or reserpine within the last 30 days.
6. Bronchial asthma or chronic obstructive pulmonary disease
7. Cardiogenic shock or severe or acute heart failure.
8. Degree II-III atrioventricular block or sinus bradycardia or heart rate ≤65/min.
9. Known sensitivity to propranolol.
10. Severe hepatic or renal insufficiency
11. History of Malignancy
12. Currently participating in other interventional clinical trials.
13. Immunosuppressant therapy or known immunosuppression.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients will receive usual care and drug use in hospital.

Treatment:

Other: control group

Propranolol group

Experimental group

Description:

Propranolol hydrochloride will be administered intravenously via pump at a initial dose of 5mg/day over a course of 7 consecutive days after randomization.

Treatment:

Drug: Propranolol Hydrochloride