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.
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;
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;
Single group
Intravenous Pump-Delivered Propranolol
DrugDuring 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.
Maximum tolerated Dose (MTD)
Determine MTD of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Adverse events assessed according to NCI-CTCAE V6.0
Evaluate the safety of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
Dose limiting toxicities (DLT)
Evaluate the tolerability of intravenous pump-delivered propranolol in patients with intracerebral hemorrhage
The incidence of SAP within 7 days post-onset.
Incidence of stroke-associated pneumonia within 7 days after onset of ICH
Time to first diagnosis of SAP after onset.
Time to first diagnosis of SAP after onset of ICH
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
Spleen volume
Spleen volume calculated based on Abdominal CT.
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