Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Yuxiu Liu, Chiyuan Ma, Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Yuxiu Liu, Chiyuan Ma

Abstract

Background: The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.

Methods: The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients' survival rate at 12 months after surgery.

Discussion: The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

Trial registration: ClinicalTrials.gov, NCT04037267 . Registered on 26 July 2019.

Keywords: Endoscopic surgery; External ventricular drainage; Intraventricular hemorrhage.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
A flowchart of the study design

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