{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Bin Gao"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Kaibin Shi"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Yuesong Pan"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Tangdu Hospital Fourth Military Medical University, Xi'an, China"
      ],
      "name": "Shunnan Ge"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Yanfang Liu"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Jing Yan"
    },
    {
      "affiliations": [
        "Institute for Stroke and Dementia Research (ISD), University Hospital, LMU Munich, Munich, Germany",
        "Munich Cluster for Systems Neurology (SyNergy), Munich, Germany"
      ],
      "name": "Arthur Liesz"
    },
    {
      "affiliations": [
        "Department of Neurology with Experimental Neurology, Neuroscience Clinical Research Center, Charité Universitätsmedizin Berlin, Berlin, Germany"
      ],
      "name": "Andreas Meisel"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Tangdu Hospital Fourth Military Medical University, Xi'an, China"
      ],
      "name": "Yan Qu"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Xingquan Zhao"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China",
        "Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China"
      ],
      "name": "Fu-Dong Shi"
    }
  ],
  "title": "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",
  "uid": "5fb77ba0-86b9-520b-ab98-4613fc5034a7"
}