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 (PROCHASE-DoE)

An Open-Label, Dose-Escalation Study on the Safety, Tolerability and Preliminary Efficacy for Preventing Stroke-Associated Pneumonia of Intravenous Pump-Delivered Propranolol in Patients With Intracerebral Hemorrhage

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hemorrhage; Stroke-Associated Pneumonia (SAP)
• Intervention / Treatment: Drug: Intravenous Pump-Delivered Propranolol

Detailed Description

The accelerated titration (ATD) incorporated with Bayesian Optimal Interval design (BOIN) will be used to assess the DLT, safety and tolerability. Eligible patients will be enrolled in the ascending dose until MTD is established.The total number of patients is estimated to be approximately 30 patients for dose escalation, but the final total number of patients will depend upon the number of dose cohorts to reach MTD and patient number at each dose level. The preliminary efficacy of continuous intravenous infusion of propranolol for preventing stroke-associated pneumonia (SAP) in patients with severe intracerebral hemorrhage will be evaluated by analyzing the incidence and timing of SAP within 7 days of onset. Throughout the study period, all subjects receiving the investigational drug will undergo lymphocyte subset analysis and abdominal CT scans (to measure splenic volume) to exploratorily assess the impact of intravenous propranolol infusion on the immune function of these patients.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Qu, M.D.; Phone Number: +86-18629074363; Email: yanqu0123@icloud.com
• Study Contact Backup: Name: Shunnan Ge, M.D.; Phone Number: +86-18165295569; Email: gesn8561@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Department of Neurosurgery , Tangdu Hospital, Fourth Military Medical University
      • Contact: Yan Qu, M.D.; Phone Number: +86-18629074363; Email: yanqu0123@icloud.com
      • Principal Investigator: Yan Qu, M.D.
      • Sub-Investigator: Shunnnan Ge, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Known to be allergic to propranolol;
• Severe liver or renal insufficiency;
• History of malignant tumors;
• Currently participating in other interventional clinical trials;
• Currently, immunosuppressants and immunotherapies are being administered.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Propranolol administered via intravenous pump for successive 7 days.

Drug: Intravenous Pump-Delivered Propranolol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of SAP within 7 days post-onset.	Incidence of stroke-associated pneumonia within 7 days after onset of ICH	up to 7 days
Time to first diagnosis of SAP after onset.	Time to first diagnosis of SAP after onset of ICH	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 7 days
Spleen volume	Spleen volume calculated based on Abdominal CT.	up to 7 days

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Propranolol; Intracerebral Hemorrhage; Dose-Escalation Study; Stroke-Associated Pneumonia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage
• Other Study ID Numbers: PROCHASE-Dose-Escalation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No