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

Primary Purpose

Stroke, Vascular Accident, Intracranial Hemorrhages

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Propranolol Hydrochloride
control group
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, propranolol, infection, treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 60 years older and no more than 90 years.
  2. Onset of new neurological deficits within≤24 hours at the time of randomization
  3. CT scan demonstrates parenchymal hemorrhage.
  4. Initial NIHSS score of 11 or greater or Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater and no more than 12 at time of enrollment.

  5. Unable to tolerate normal diet or fluids because of:

    1. impaired consciousness levels.
    2. failed clinical bedside swallowing assessment performed by a trained assessor.
    3. "nil orally" orders, nasogastric tubes, modified diet or requiring compensatory feeding techniques.
  6. Admission without infection signs. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

Exclusion Criteria:

  1. Time of symptom onset cannot be reliably assessed.
  2. Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service.
  3. Pregnancy or parturition within previous 30 days or active lactation.
  4. Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, and etc.) or antibiotics within the last 30 days.
  5. Use of reserpine within the last 30 days.
  6. Pre-stroke dementia or disability.
  7. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
  8. Bronchial asthma or COPD.
  9. Cardiogenic shock or severe or acute heart failure.
  10. Degree II-III atrioventricular block or sinus bradycardia (heart rate ≤75/min).
  11. Known sensitivity to propranolol.
  12. Currently participating in other interventional clinical trials.
  13. Immunosuppressant therapy or known immunosuppression.

Sites / Locations

  • Beijing Tiantan Hospital,Capital Medical UniversityRecruiting
  • Zhangda Hospital Southeast UniversityRecruiting
  • Tianjin Huanhu HospitalRecruiting
  • Tianjin Third Central HospitalRecruiting
  • Tangdu Hospital,Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Propranolol group

Arm Description

Patients will receive usual care and drug use in hospital.

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

Outcomes

Primary Outcome Measures

Incidence of stroke-associated pneumonia
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.

Secondary Outcome Measures

Change in immunology function
Use the flow cytometry to measure the change of ratio and number of CD4+、CD8+、NK 、B cells at baseline, 3 days, 7 days
Spleen volume
Spleen volume calculated based on Abdominal CT.
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.
Adverse Event (AE)
Per protocol Adverse Event (AE), Adverse Reaction (AR), Serious Adverse Event / Reaction (SAE / SAR), and Suspected Unexpected Serious Adverse Reactions (SUSAR)

Full Information

First Posted
June 2, 2022
Last Updated
February 22, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05419193
Brief Title
PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
Acronym
PRO-CHASE
Official Title
Efficacy and Safety of Propranolol for the Post-Stroke Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
July 3, 2024 (Anticipated)
Study Completion Date
July 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
This study will enroll 100 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Vascular Accident, Intracranial Hemorrhages, Intracerebral Hemorrhage, Hemorrhagic Stroke, Stroke, Acute
Keywords
Stroke, propranolol, infection, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive usual care and drug use in hospital.
Arm Title
Propranolol group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propranolol Hydrochloride
Intervention Description
Day of randomization: propranolol IV vp for 7 days after randomization
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
Patients will receive usual care and drug use in hospital
Primary Outcome Measure Information:
Title
Incidence of stroke-associated pneumonia
Description
Stroke-associated pneumonia diagnosed in accordance to a defined algorithm.
Time Frame
up to 7days
Secondary Outcome Measure Information:
Title
Change in immunology function
Description
Use the flow cytometry to measure the change of ratio and number of CD4+、CD8+、NK 、B cells at baseline, 3 days, 7 days
Time Frame
up to 7 days
Title
Spleen volume
Description
Spleen volume calculated based on Abdominal CT.
Time Frame
up to 7 days
Title
Clinical improvement
Description
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.
Time Frame
up to 90 days
Title
Adverse Event (AE)
Description
Per protocol Adverse Event (AE), Adverse Reaction (AR), Serious Adverse Event / Reaction (SAE / SAR), and Suspected Unexpected Serious Adverse Reactions (SUSAR)
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years older and younger than 80 years old. Onset of new neurological deficits within≤24 hours at the time of randomization CT scan demonstrates parenchymal hemorrhage and hematoma volume>20mL. Initial NIHSS score of 11 or greater or Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater and no more than 12 at time of enrollment. Admission without infection signs. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained. Exclusion Criteria: Time of symptom onset cannot be reliably assessed. Subjects is considered a candidate for immediate surgical intervention by the neurosurgery service. Pregnancy or parturition within previous 30 days or active lactation. Use of beta blockers (propranolol, metoprolol, sotalol, carvedilol, bisoprolol, atenolol, esmolol, and etc.) or antibiotics within the last 30 days. Use of reserpine within the last 30 days. Pre-stroke dementia or disability. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days. Bronchial asthma or COPD. Cardiogenic shock or severe or acute heart failure. Degree II-III atrioventricular block or sinus bradycardia (heart rate ≤75/min). Known sensitivity to propranolol. Currently participating in other interventional clinical trials. Immunosuppressant therapy or known immunosuppression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu-Dong Shi, MD
Phone
8610-59976585
Email
fshi@tmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xingquan Zhao, MD
Phone
+0086 13501031486
Email
zxq@vip.163.com
Facility Information:
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingquan Zhao, MD
Facility Name
Zhangda Hospital Southeast University
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wang, MD
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zilong Zhu, MD
Facility Name
Tianjin Third Central Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhang, MD
Facility Name
Tangdu Hospital,Air Force Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Qu, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.

Learn more about this trial

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

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