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Published in: Trials 1/2020

Open Access 01-12-2020 | Hematoma | Study protocol

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

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

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
Literature
1.
Basaldella L, Marton E, Fiorindi A, Scarpa B, Badreddine H, Longatti P. External ventricular drainage alone versus endoscopic surgery for severe intraventricular hemorrhage: a comparative retrospective analysis on outcome and shunt dependency. Neurosurg Focus. 2012;32(4):E4.PubMed
2.
Hallevi H, Albright KC, Aronowski J, Barreto AD, Martin-Schild S, Khaja AM, Gonzales NR, Illoh K, Noser EA, Grotta JC. Intraventricular hemorrhage: anatomic relationships and clinical implications. Neurology. 2008;70(11):848–52.PubMedPubMedCentral
3.
An SJ, Kim TJ, Yoon BW. Epidemiology, risk factors, and clinical features of intracerebral hemorrhage: an update. J Stroke. 2017;19(1):3–10.PubMedPubMedCentral
4.
Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH, investigators S. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005;365(9457):387–97.PubMed
5.
Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM, Investigators SI. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013;382(9890):397–408.PubMedPubMedCentral
6.
Bhattathiri PS, Gregson B, Prasad KS, Mendelow AD, Investigators S. Intraventricular hemorrhage and hydrocephalus after spontaneous intracerebral hemorrhage: results from the STICH trial. Acta Neurochir Suppl. 2006;96:65–8.PubMed
7.
Huttner HB, Kohrmann M, Berger C, Georgiadis D, Schwab S. Influence of intraventricular hemorrhage and occlusive hydrocephalus on the long-term outcome of treated patients with basal ganglia hemorrhage: a case-control study. J Neurosurg. 2006;105(3):412–7.PubMed
8.
Castano Avila S, Corral Lozano E, Vallejo De La Cueva A, Maynar Moliner J, Martin Lopez A, Fonseca San Miguel F, Urturi Matos JA, Manzano Ramirez A. Intraventricular hemorrhage treated with intraventricular fibrinolysis. A 10-year experience. Med Int. 2013;37(2):61–6.
9.
Dunatov S, Antoncic I, Bralic M, Jurjevic A. Intraventricular thrombolysis with rt-PA in patients with intraventricular hemorrhage. Acta Neurol Scand. 2011;124(5):343–8.PubMed
10.
King NK, Lai JL, Tan LB, Lee KK, Pang BC, Ng I, Wang E. A randomized, placebo-controlled pilot study of patients with spontaneous intraventricular haemorrhage treated with intraventricular thrombolysis. J Clin Neurosci. 2012;19(7):961–4.PubMed
11.
Gaberel T, Magheru C, Parienti JJ, Huttner HB, Vivien D, Emery E. Intraventricular fibrinolysis versus external ventricular drainage alone in intraventricular hemorrhage: a meta-analysis. Stroke. 2011;42(10):2776–81.PubMed
12.
Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46(7):2032–60.PubMed
13.
Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, et al. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017;389(10069):603–11.PubMedPubMedCentral
14.
Chen CC, Liu CL, Tung YN, Lee HC, Chuang HC, Lin SZ, Cho DY. Endoscopic surgery for intraventricular hemorrhage (IVH) caused by thalamic hemorrhage: comparisons of endoscopic surgery and external ventricular drainage (EVD) surgery. World Neurosurg. 2011;75(2):264–8.PubMed
15.
Yadav YR, Mukerji G, Shenoy R, Basoor A, Jain G, Nelson A. Endoscopic management of hypertensive intraventricular haemorrhage with obstructive hydrocephalus. BMC Neurol. 2007;7:1.PubMedPubMedCentral
16.
Song P, Duan FL, Cai Q, Wu JL, Chen XB, Wang Y, Huang CG, Li JQ, He ZQ, Huang QC, et al. Endoscopic surgery versus external ventricular drainage surgery for severe intraventricular hemorrhage. Curr Med Sci. 2018;38(5):880–7.PubMed
17.
Du B, Shan AJ, Peng YP, Wang J, Peng KW, Zhong XL, Zhang Y. A new modified neuroendoscope technology to remove severe intraventricular haematoma. Brain Inj. 2018;32(9):1142–8.PubMed
18.
Idris Z, Raj J, Abdullah JM. Early experience in endoscopic management of massive intraventricular hemorrhage with literature review. Asian J Neurosurg. 2014;9(3):124–9.PubMedPubMedCentral
19.
Komatsu F, Komatsu M, Wakuta N, Oshiro S, Tsugu H, Iwaasa M, Inoue T. Comparison of clinical outcomes of intraventricular hematoma between neuroendoscopic removal and extraventricular drainage. Neurol Med Chir (Tokyo). 2010;50(11):972–6.
20.
Longatti PL, Martinuzzi A, Fiorindi A, Maistrello L, Carteri A. Neuroendoscopic management of intraventricular hemorrhage. Stroke. 2004;35(2):e35–8.PubMed
21.
Blackwelder WC. “Proving the null hypothesis” in clinical trials. Control Clin Trials. 1982;3(4):345–53.PubMed
22.
Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004;23(12):1921–86.PubMed
Metadata
Title
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
Authors
Junhao Zhu
Chao Tang
Zixiang Cong
Jin Yang
Xiangming Cai
Yuxiu Liu
Chiyuan Ma
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04560-3

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