Safety of surgical Treatment In severe primary Pontine haemorrhage Evacuation (STIPE): study protocol for a multi-centre, randomised, controlled, open-label trial

Abstract

Introduction Primary pontine haemorrhage (PPH) is the most devastating subtype of intracerebral haemorrhage and is associated with poor prognosis, especially for the severe patients. Although medical treatment (MT) is widely accepted, a large number of studies have shown surgical haematoma evacuation (HE) might dramatically reduce mortality and improve prognosis outcome in severe PPH (sPPH). However, evidence to clarify the safety of HE remains insufficient. Methods and analysis The Safety of surgical Treatment In severe primary Pontine haemorrhage Evacuation study is a multi-centre, randomised, controlled, open-label trial, conducted from January 2022 to November 2024 in 20 tertiary hospitals in China. A total of 64 patients with sPPH will be randomly assigned to MT or HE group. Eligible patients will receive the corresponding treatment according to the result of randomisation. The primary outcomes are related to the safety of surgery including rate of symptomatic rebleeding at 3 days and rate of mortality and intracranial infection at 30 days. The secondary outcomes are the neurological function indexes following up at 30 days, 90 days, 180 days and 365 days. Ethics and dissemination The clinical trial has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (unique identifiers: No. 2020-894). All results of the trial will be published in international peer-reviewed scientific journals and will be disseminated through scientific conferences. Academic dissertation will be published in a peer-reviewed journal.