An Open-Label, Dose-Escalation Study on the Safety, Tolerability and Preliminary Efficacy for Pre… (NCT07528235) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
China30 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range10 Years – 80 Years
SexALL
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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.
What they're measuring
1
Maximum tolerated Dose (MTD)
Timeframe: up to 7 days
2
Adverse events assessed according to NCI-CTCAE V6.0