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

Last updated: March 16, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed

Phase

2

Condition

Pneumonia

Stroke

Hemorrhage

Treatment

control group

Propranolol Hydrochloride

Clinical Study ID

NCT05419193
KY-2022-05-07-001
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofhematoma≥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 orgreater 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

Exclusion Criteria:

  1. Subjects is considered a candidate for immediate surgical intervention by theneurosurgery service, including surgical evacuation of hematoma, decompressivecraniectomy, minimally invasive aspiration of hematoma, and ventricular shunt orexternal ventricular drainage for intracerebral hemorrhage into the ventricle.

  2. Patients with primary intraventricular hemorrhage or cerebral hemorrhage due to adefinite cause, such as trauma, vascular malformation, aneurysm, coagulopathy,anticoagulant or antiplatelet drugs, thrombolytic therapy, post-infarctionhemorrhagic transformation, hematologic disease, moyamoya disease, primary ormetastatic 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.

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: control group
Phase: 2
Study Start date:
February 21, 2023
Estimated Completion Date:
March 11, 2025

Study 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.

Connect with a study center

  • Lu'an Hospital of Traditional Chinese Medicine

    Lu'an, Anhui
    China

    Site Not Available

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, Beijing 100070
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Third Affiliated Hospital, Soochow University

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Zhangda Hospital Southeast University

    Nanjing, Jiangsu
    China

    Site Not Available

  • Weinan City Center hospital

    Weinan, Shaanxi
    China

    Site Not Available

  • Tangdu Hospital,Air Force Medical University

    Xi'an, Shaanxi
    China

    Site Not Available

  • Xi'an Central Hospital

    Xi'an, Shaanxi
    China

    Site Not Available

  • Qianxian People's Hospital

    Xianyang, Shaanxi
    China

    Site Not Available

  • The First People' Hospital of Xian Yang

    Xianyang, Shaanxi
    China

    Site Not Available

  • Xianyang hospital affliated of Yan'an University

    Xianyang, Shaanxi
    China

    Site Not Available

  • The 970th Hospital of the Chinese People's Liberation Army (Weihai Branch)

    Weihai, Shandong
    China

    Site Not Available

  • The 970th Hospital of the Chinese People's Liberation Army (Yantai Branch)

    Yantai, Shandong
    China

    Site Not Available

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Third Central Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

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