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

Stroke Clinical Trial

— PRO-CHASE  

Official title:

Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419193
• Other study ID #: KY-2022-05-07-001
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2023
• Est. completion date: July 3, 2025

Study information

• Verified date: November 2023
• Source: Beijing Tiantan Hospital
• Contact: Fu-Dong Shi, MD
• Phone: 8610-59976585
• Email: fshi[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: July 3, 2025
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage
• Intracranial Hemorrhages
• Pneumonia
• Stroke
• Stroke, Acute
• Vascular Accident

Intervention

Drug:
• Propranolol Hydrochloride
Day of randomization: propranolol IV vp for 7 days after randomization

Other:
• control group
Patients will receive usual care and drug use in hospital

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital,Capital Medical University	Beijing	Beijing
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Zhangda Hospital Southeast University	Nanjing	Jiangsu
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	Weinan City Center hospital	Weinan	Shaanxi
China	Tangdu Hospital,Air Force Medical University	Xi'an	Shaanxi
China	Xianyang hospital affliated of Yan'an University	Xianyang	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke-associated pneumonia	Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.	up to 7days
Secondary	Clinical improvement	Modified Rankin Scale (mRS,0-6 scores, poor outcome defined as mRS=4)are used to describe the clinical improvement at baseline, 7days, 14days, 30days and 90days.	up to 90 days
Secondary	Change in immunology function [ Time Frame: up to 7 days ](ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation)	Use the flow cytometry to measure the change of ratio and number of CD4+?CD8+?NK ?B cells at baseline, 3 days, 7 days	up to 7 days
Secondary	Spleen volume [ Time Frame: up to 7 days ] (ONLY patients recruited from Beijing Tiantan hospital and Tangdu Hospital, Air Force Medical University will receive this evaluation)	Spleen volume calculated based on Abdominal CT.	up to 7 days
Secondary	Adverse Event (AE)	Per protocol Adverse Event (AE), Adverse Reaction (AR), Serious Adverse Event / Reaction (SAE / SAR), and Suspected Unexpected Serious Adverse Reactions (SUSAR)	up to 90 days