Clinical trial NCT04957862: Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage
Official title: Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertensive Intracerebral Hemorrhage
Keywords: Randomized controlled trial
Hypertensive Intracerebral Hemorrhage
subacute
chronic
robotic assisted evacuation
function rehabilitation
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tian Tan Hospital Affiliated to Capital Medical University
name: Tianjin Medical University General Hospital
name: Peking Union Medical College Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Renmin Hospital of Wuhan University
name: South Taihu Hospital of Huzhou
name: Qian Xi Nan People's Hospital
name: Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)
name: Fujian Provincial Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: LanZhou University
name: Anhui No.2 Provincial People's Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Jinjiang Hospital of Traditional Chinese Medicine
name: Tang-Du Hospital
name: Wuhan Union Hospital, China
name: Shenzhen People's Hospital
name: Shaanxi Provincial People's Hospital
name: Shanghai 6th People's Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Sanhe Yanjiao People's Hospital
name: General Hospital of Ningxia Medical University
name: Affiliated Hospital of Chifeng University
name: Haikou People's Hospital
name: Qilu Hospital of Shandong University
name: Xiangya Hospital of Central South University
First posted: 2021-07-12
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: The inclusion criteria are HICH patients who: (1) are ≥ 18 and ≤ 75 years old of either gender; (2) have evidence of supratentorial, deep-seated on CT scan with a volume of between 15 mL and 30 mL; (3) are within 24 h of ictus (\<24 h between symptom onset and initial imaging); (4) have stable hematoma (hematoma growth\<5 mL) for at least 12 h after diagnostic CT; (5) have no brain herniation and no needs for emergency surgery (clinical decisions made by 2 attending neurosurgeons); (6) have had no previous surgery on HICH or traumatic brain injury; (7) have GCS\>8, NIH Stroke Scale (NIHSS)\>5, Modified Rankin Scale (mRS) 3-5, and FMA scale\<85; (8) fully understand the nature of the study and have signed informed consent.

The exclusion criteria are: (1) HICH caused by aneurysms, cerebrovascular malformations, tumors or trauma; (2) any pre-existing physical or mental disorder that could interfere with the functional assessment; (3) severe abnormal coagulation function, hematologic diseases or multiple hemorrhagic lesions; (4) excessive hematoma extending into the ventricular system with ventricular dilation; (5) concomitant diseases such as liver, kidney and heart failure; (6) rebleeding\>5 mL or with surgical indications before allocation; (7) poor adherence or other unsuitable situations for the trial as determined by the investigators; (8) pregnant female.

Primary outcomes:
measure: modified Rankin Scale (mRS) 0-2
timeFrame: 180 days after surgery
Secondary outcomes:
measure: Evacuation rate of HICH
timeFrame: at the first day after procedure, 30 days and 180 days during the follow-up period.
measure: modified Rankin Scale (mRS) 0-1
timeFrame: 180 days after surgery
measure: between-group shift analysis in the mRS distribution
timeFrame: 180 days after surgery
measure: Extended Glasgow Outcome Scale (eGOS)
timeFrame: at 90- and 180-days after surgery.
measure: NIH Stroke Scale（NIHSS）
timeFrame: at 90- and 180-days after surgery.
measure: Barthel Index for Activities of Daily Living (ADL-BI)
timeFrame: at 90- and 180-days after surgery.
measure: Fugl-Meyer Assessment (FMA)
timeFrame: at 90- and 180-days after surgery.
measure: Motor Assessment Scale (MAS)
timeFrame: at 90- and 180-days after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Lijun Hou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Tao Xu, MD,PhD
role: STUDY_DIRECTOR
References: