Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage

Not Applicable

Not yet recruiting

• Conditions: Hypertensive Intracerebral Hemorrhage
• Interventions: Procedure: Robotic Assisted Evacuation

• Registration Number: NCT04957862
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial

Detailed Description

Background: Hypertensive intracerebral hemorrhage (HICH) is a devastating neurological disorder with high mortality and disability rates. Secondary injury following HICH may worsen motor function rehabilitation in subacute and chronic hematoma. Hematoma evacuation has the potential to reduce mass effect and mitigate the neurotoxic effects. A per-protocol analysis identified a significant functional improvement in patients with minimally invasive surgery with thrombolysis achieving end of treatment (EOT) goal ≤ 15mL. However, no surgical management of stabilized subacute or chronic HICH have been reported before. Therefore, we design this study in which we hypothesize this robotic assisted approach to hematoma EOT goal ≤ 15mL would accelerate functional rehabilitation in subacute and chronic HICH patients.

Study Timeline

• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-03
• Study First Posted: 2021-07-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-07
• Last Update Posted: 2022-08-10
• Study Start: 2022-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic assisted evacuation	Robotic Assisted Evacuation	In the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia.

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) 0-2	180 days after surgery	The modified Rankin Scale (mRS) is a single item, global outcomes rating scale for patients post-stroke. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) 0-1	180 days after surgery	The modified Rankin Scale (mRS) is a single item, global outcomes rating scale for patients post-stroke. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.
Barthel Index for Activities of Daily Living (ADL-BI)	at 90- and 180-days after surgery.	The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care.
between-group shift analysis in the mRS distribution	180 days after surgery	The modified Rankin Scale (mRS) is a single item, global outcomes rating scale for patients post-stroke. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.
Extended Glasgow Outcome Scale (eGOS)	at 90- and 180-days after surgery.	The GOS-E adds to the original 5 GOS categories, with 3 additional categories. The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.
Motor Assessment Scale (MAS)	at 90- and 180-days after surgery.	The MAS is comprised of 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded.; Supine to side lying Supine to sitting over the edge of a bed Balanced sitting Sitting to standing Walking Upper-arm function Hand movements Advanced hand activities
Evacuation rate of HICH	at the first day after procedure, 30 days and 180 days during the follow-up period.	the ratio of effective volume reduction to the initial volume
Fugl-Meyer Assessment (FMA)	at 90- and 180-days after surgery.	The FMA motor assessments for the upper (maximum score 66 points) and lower extremity (maximum score 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial.
NIH Stroke Scale（NIHSS）	at 90- and 180-days after surgery.	The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete. The evaluation of stroke severity depends upon the ability of the observer to accurately and consistently assess the patient