An Open-Label, Dose-Escalation Study on the Safety, Tolerability and Preliminary Efficacy for Preventing SAP by Intravenous Pump-Delivered Propranolol in Patients With ICH

NCT07528235 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PROCHASE-Dose-Escalation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, dose-escalation study on the safety, tolerability and preliminary efficacy for preventing stroke-associated pneumonia of propranolol in patients with intracerebral hemorrhage. Propranolol is administered via intravenous pump continuously for 7 days.

Conditions

Intracerebral Hemorrhage; Stroke-Associated Pneumonia (SAP)

Keywords

Propranolol; Intracerebral Hemorrhage; Stroke-Associated Pneumonia; Dose-Escalation Study

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated Dose (MTD)

  Determine MTD of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage

  up to 7 days

• Adverse events assessed according to NCI-CTCAE V6.0

  Evaluate the safety of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage

  up to 7 days

• Dose limiting toxicities (DLT)

  Evaluate the tolerability of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage

  up to 7 days

Secondary Outcomes (2)

• The incidence of SAP within 7 days post-onset.

  up to 7 days

• Time to first diagnosis of SAP after onset.

  up to 7 days

Other Outcomes (2)

• Change in immunology function

  up to 7 days

• Spleen volume

  up to 7 days

Study Arms (1)

Propranolol administered via intravenous pump for successive 7 days.

EXPERIMENTAL

Drug: Intravenous Pump-Delivered Propranolol

Interventions

Intravenous Pump-Delivered Propranolol DRUG

During the dose escalation phase, the proposed five dose levels of intravenous pump infusion of propranolol hydrochloride injection are as follows: * 0.01 mg/kg/h, administered as one group over 2 hours; repeated every 6 hours, with 3 groups per 24 hours, avoiding the period from 02:00 to 06:00 at night; * 0.02 mg/kg/h, administered as one group over 2 hours; repeated every 6 hours, with 3 groups per 24 hours, avoiding the period from 02:00 to 06:00 at night; * 0.03 mg/kg/h, administered as one group over 2 hours; repeated every 6 hours, with 3 groups per 24 hours, avoiding the period from 02:00 to 06:00 at night; ④ 0.04 mg/kg/h, administered as one group over 2 hours; repeated every 6 hours, with 3 groups per 24 hours, avoiding the period from 02:00 to 06:00 at night; ⑤ 0.05 mg/kg/h, administered as one group over 2 hours; repeated every 6 hours, with 3 groups per 24 hours, avoiding the period from 02:00 to 06:00 at night.

Propranolol administered via intravenous pump for successive 7 days.

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> 18 and ≤ 80 years of age;
• Can be treated with the study drug within 24 h of symptom onset;
• No fever or infection was observed upon admission;
• NIHSS score ≥10;
• Supratentorial parenchymal haematoma (≥10 mL);
• GCS score ≥ 6;
• Patients or their family members sign informed consent forms.

You may not qualify if:

• Infections within the last 4 weeks;
• Use of antibiotics within the last 2 weeks;
• Known pre-ICH dysphagia;
• Secondary intracerebral hemorrhage or intraventricular hemorrhage resulting from trauma, vascular malformation, aneurysm, coagulopathy, anticoagulant drugs, thrombolysis, post-infarction hemorrhage transformation, hematopathy, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, vasculitis, and other definite causes;
• Previous disability with pre-ICH mRS score ≥ 2;
• Brainstem hemorrhage;
• Life expectancy less than 14 days;
• Death appeared imminent;
• Pregnancy or within 30 d of delivery;
• Previous use (within 1 month) of β-blockers or reserpine;
• Bronchial asthma or COPD;
• Cardiogenic shock;
• Degree II-III atrioventricular blocks;
• Severe or acute heart failure;
• Heart rate \< 65 beats/min;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Department of Neurosurgery , Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Qu, M.D.

CONTACT

+86-18629074363; yanqu0123@icloud.com

Shunnan Ge, M.D.

CONTACT

+86-18165295569; gesn8561@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)