RT Journal Article
SR Electronic
T1 Multicentre prospective, randomised open-label, endpoint-blinded study to evaluate the safety and efficacy of propranolol for the prevention of stroke-associated pneumonia in patients with intracerebral haemorrhage (PROCHASE): rationale and design
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2024-003630
DO 10.1136/svn-2024-003630
A1 Gao, Bin
A1 Shi, Kaibin
A1 Pan, Yuesong
A1 Ge, Shunnan
A1 Liu, Yanfang
A1 Yan, Jing
A1 Liesz, Arthur
A1 Meisel, Andreas
A1 Qu, Yan
A1 Zhao, Xingquan
A1 Shi, Fu-Dong
YR 2024
UL http://svn.bmj.com/content/early/2024/12/31/svn-2024-003630.abstract
AB Background Stroke-induced transient immune suppression is believed to contribute to post-stroke infections. The β-adrenergic receptor antagonist, propranolol, has been shown to prevent stroke-associated pneumonia (SAP) via reversing post-stroke immunosuppression in preclinical studies and in retrospective analysis in stroke patients. However, whether propranolol can reduce the risk of SAP has not been tested in prospective, randomised controlled trials.Aim To describe the rationale and design of a multicentre, prospective, open-label, endpoint-blinded, randomised controlled study to evaluate the safety and efficacy of propranolol hydrochloride injection for the prevention of SAP in patients with intracerebral haemorrhage (ICH) (PROCHASE).Design In this investigator-initiated trial, we compare the safety of the standard medical treatment to standard medical treatment plus intravenous propranolol hydrochloride administration (5 mg daily on days 1–7) in patients with ICH and the efficacy of this intervention to reduce the occurrence of SAP. All patients will be followed up for 90±7 days.Study outcomes The primary efficacy outcome is SAP within 7±1 days diagnosed by the defined algorithm based on a diagnosis of SAP recommendations from the pneumonia in stroke consensus group. The primary safety outcome is defined as severe or moderate bradycardia within 7±1 days. The secondary outcome is a modified Rankin score of 0–3 at 90±7 days after randomisation.Discussion The PROCHASE trial aims to generate clinical evidence regarding the safety and efficacy of propranolol in preventing SAP in patients with ICH.Data sharing not applicable as no datasets generated and/or analysed for this study. Data sharing is not applicable as no analyzable dataset was generated in this study.