Intracerebral HemorrhagePhase 1PROCHASE-DoENCT07528235
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
A Phase 1 study testing Intravenous Pump-Delivered Propranolol in people with Intracerebral Hemorrhage and Stroke-Associated Pneumonia (SAP), run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke-Associated Pneumonia (SAP)
- What is being tested?
- Intravenous Pump-Delivered Propranolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurosurgery , Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
Yan Qu, M.D., +86-18629074363, yanqu0123@icloud.com
Yan Qu, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- Intravenous Pump-Delivered Propranolol
- Keywords
- Propranolol, Intracerebral Hemorrhage, Stroke-Associated Pneumonia, Dose-Escalation Study
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Pump-Delivered PropranololDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol administered via intravenous pump for successive 7 days. | Experimental | Not described Receives: Drug: Intravenous Pump-Delivered Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated Dose (MTD)
Determine MTD of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Measured: 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
Measured: up to 7 days
Dose limiting toxicities (DLT)
Evaluate the tolerability of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Measured: up to 7 days
Secondary outcomes (2)
The incidence of SAP within 7 days post-onset.
Incidence of stroke-associated pneumonia within 7 days after onset of ICH
Measured: up to 7 days
Time to first diagnosis of SAP after onset.
Time to first diagnosis of SAP after onset of ICH
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528235
- Sponsor's protocol ID
- PROCHASE-Dose-Escalation
- Acronym
- PROCHASE-DoE
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol,statistical analysis plan(SAP),informed consent form(ICF),clinical study report(CSR),analytic code will be shared with other researchers.