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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial

Authors: Xinghua Xu, Yi Zheng, Xiaolei Chen, Fangye Li, Huaping Zhang, Xin Ge

Published in: Trials | Issue 1/2017

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Abstract

Background

Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuation or stereotactic aspiration is still insufficient.

Methods/design

A multicentre, randomised controlled trial will be conducted to compare the efficacy of endoscopic evacuation, stereotactic aspiration and craniotomy in the treatment of supratentorial HICH. About 1350 eligible patients from 10 neurosurgical centres will be randomly assigned to an endoscopic group, a stereotactic group and a craniotomy group at a 1:1:1 ratio. Randomisation is undertaken using a 24-h randomisation service accessed by telephone or the Internet. All patients will receive the corresponding surgery based on their grouping. They will be followed-up at 1, 3 and 6 months after surgery. The primary outcome is the modified Rankin Scale at 6-month follow-up. Secondary outcomes include: haematoma clearance rate; Glasgow Coma Scale 7 days after surgery; rebleeding rate; intracranial infection rate; hospitalisation time; mortality at 1 month and 3 months after surgery; the Barthel Index and the WHO quality of life at 3 months and 6 months after surgery.

Discussion

The trial aims to investigate whether endoscopic evacuation and stereotactic aspiration could improve the outcome of supratentorial HICH compared with craniotomy. The trial will help to determine the best surgical method for the treatment of supratentorial HICH.

Trial registration

ClinicalTrials.gov, ID: NCT02811614. Registered on 20 June 2016.
Appendix
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Metadata
Title
Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial
Authors
Xinghua Xu
Yi Zheng
Xiaolei Chen
Fangye Li
Huaping Zhang
Xin Ge
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2041-1

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