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
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.
Study 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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Maximum tolerated Dose (MTD) — up to 7 days Determine MTD of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Adverse events assessed according to NCI-CTCAE V6.0 — up to 7 days Evaluate the safety of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Dose limiting toxicities (DLT) — up to 7 days Evaluate the tolerability of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Trial sites (1)
Facility
City
Region
Status
Department of Neurosurgery , Tangdu Hospital, Fourth Military Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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