Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681988
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2022-12-20
Brief Title:
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage EMINENT-ICH
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage EMINENT-ICH a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMINENT-ICH
Brief Summary:
This is an open-labelled single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage
Detailed Description:
Spontaneous supratentorial intracerebral haemorrhage SSICH is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage Treatment options for SSICH consist of either the current gold standard best medical treatment BMT or surgical hematoma evacuation Neither the best medical treatment nor the established surgical mainstay conventional craniotomy have shown relevant improvement of survival or functional outcome rates A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed Endoscopic surgery was shown to be safe and effective however large trials analyzing the benefits of endoscopic surgery are lacking An earlier more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients The primary objective of this two-armed open-labelled single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH The study procedures include 6 visits in total 4 of them during hospital stay 2 of them as follow-up visits within the clinical routine Each visit consists of assessing Glasgow Coma Scale GCS modified Rankin Scale mRS and National Institute of Health Stroke Scale NIHSS three visits include CT scans before intervention directly postoperative and during follow up and blood sampling before intervention postoperative and during follow up Three visits include assessing patient satisfaction and cognition and two visits include patient quality of life assessments This study was designed in collaboration with Patient and Public representatives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None