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)

April 7, 2026 updated by: Tang-Du Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Department of Neurosurgery , Tangdu Hospital, Fourth Military Medical University
        • Contact:
        • Principal Investigator:
          • Yan Qu, M.D.
        • Sub-Investigator:
          • Shunnnan Ge, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: up to 7 days
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
Time Frame: up to 7 days
Evaluate the safety of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
up to 7 days
Dose limiting toxicities (DLT)
Time Frame: up to 7 days
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.
Time Frame: up to 7 days
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 Frame: up to 7 days
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
Time Frame: up to 7 days
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
Time Frame: up to 7 days
Spleen volume calculated based on Abdominal CT.
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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