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
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.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Posted 15 Jun, 2020
On 13 Jul, 2020
On 26 Jun, 2020
Invitations sent on 21 Jun, 2020
On 12 Jun, 2020
On 11 Jun, 2020
On 15 May, 2020
On 08 May, 2020
Received 08 May, 2020
Received 16 Mar, 2020
On 15 Mar, 2020
Invitations sent on 12 Mar, 2020
On 04 Mar, 2020
On 03 Mar, 2020
On 19 Feb, 2020
Received 12 Feb, 2020
On 07 Feb, 2020
Received 03 Feb, 2020
Invitations sent on 30 Jan, 2020
On 30 Jan, 2020
On 18 Nov, 2019
On 23 Oct, 2019
On 18 Oct, 2019
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
Posted 15 Jun, 2020
On 13 Jul, 2020
On 26 Jun, 2020
Invitations sent on 21 Jun, 2020
On 12 Jun, 2020
On 11 Jun, 2020
On 15 May, 2020
On 08 May, 2020
Received 08 May, 2020
Received 16 Mar, 2020
On 15 Mar, 2020
Invitations sent on 12 Mar, 2020
On 04 Mar, 2020
On 03 Mar, 2020
On 19 Feb, 2020
Received 12 Feb, 2020
On 07 Feb, 2020
Received 03 Feb, 2020
Invitations sent on 30 Jan, 2020
On 30 Jan, 2020
On 18 Nov, 2019
On 23 Oct, 2019
On 18 Oct, 2019
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.
Figure 1