Back to resultsRobotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage
Primary Purpose
Hypertensive Intracerebral Hemorrhage
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robotic Assisted Evacuation
Sponsored by
About this trial
This is an interventional treatment trial for Hypertensive Intracerebral Hemorrhage focused on measuring Randomized controlled trial, Hypertensive Intracerebral Hemorrhage, subacute, chronic, robotic assisted evacuation, function rehabilitation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
robotic assisted evacuation
Concomitant care
Arm Description
In the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia.
All enrolled HICH patients in this study will receive standard medical treatment in the first 3-4 weeks according to the ASA/AHA guideline . Continued medical treatment is applied to patients in the control arm. Both arms will receive identical rehabilitation therapy three times per week for 180 days at one facility. Rehabilitation therapy includes identical physical therapy, occupational therapy, speech therapy, functional training, acupuncture and massage.
Outcomes
Primary Outcome Measures
modified Rankin Scale (mRS) 0-2
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
Evacuation rate of HICH
the ratio of effective volume reduction to the initial volume
modified Rankin Scale (mRS) 0-1
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.
between-group shift analysis in the mRS distribution
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)
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.
NIH Stroke Scale（NIHSS）
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
Barthel Index for Activities of Daily Living (ADL-BI)
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.
Fugl-Meyer Assessment (FMA)
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.
Motor Assessment Scale (MAS)
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
Full Information
NCT ID
NCT04957862
First Posted
July 3, 2021
Last Updated
August 7, 2022
Sponsor
Shanghai Changzheng Hospital
Collaborators
Beijing Tian Tan Hospital Affiliated to Capital Medical University, Tianjin Medical University General Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Harbin Medical University, Renmin Hospital of Wuhan University, South Taihu Hospital of Huzhou, Qian Xi Nan People's Hospital, Huazhong University of Science and Technology Union Hospital (Nanshan Hospital), Fujian Provincial Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, LanZhou University, Anhui No.2 Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Jinjiang Hospital of Traditional Chinese Medicine, Tang-Du Hospital, Wuhan Union Hospital, China, Shenzhen People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 6th People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sanhe Yanjiao People's Hospital, General Hospital of Ningxia Medical University, Affiliated Hospital of Chifeng University, Haikou People's Hospital, Qilu Hospital of Shandong University, Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04957862
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
Beijing Tian Tan Hospital Affiliated to Capital Medical University, Tianjin Medical University General Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Harbin Medical University, Renmin Hospital of Wuhan University, South Taihu Hospital of Huzhou, Qian Xi Nan People's Hospital, Huazhong University of Science and Technology Union Hospital (Nanshan Hospital), Fujian Provincial Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, LanZhou University, Anhui No.2 Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Jinjiang Hospital of Traditional Chinese Medicine, Tang-Du Hospital, Wuhan Union Hospital, China, Shenzhen People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 6th People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sanhe Yanjiao People's Hospital, General Hospital of Ningxia Medical University, Affiliated Hospital of Chifeng University, Haikou People's Hospital, Qilu Hospital of Shandong University, Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Intracerebral Hemorrhage
Keywords
Randomized controlled trial, Hypertensive Intracerebral Hemorrhage, subacute, chronic, robotic assisted evacuation, function rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
428 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic assisted evacuation
Arm Type
Active Comparator
Arm Description
In the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia.
Arm Title
Concomitant care
Arm Type
No Intervention
Arm Description
All enrolled HICH patients in this study will receive standard medical treatment in the first 3-4 weeks according to the ASA/AHA guideline . Continued medical treatment is applied to patients in the control arm. Both arms will receive identical rehabilitation therapy three times per week for 180 days at one facility. Rehabilitation therapy includes identical physical therapy, occupational therapy, speech therapy, functional training, acupuncture and massage.
Intervention Type
Procedure
Intervention Name(s)
Robotic Assisted Evacuation
Intervention Description
On the day of surgery, the patient is placed in the prone position. After the Mayfield skull clamp is positioned to reduce interference, the videometric tracker of robot will automatically scan the preliminary markers to complete patient-to-image registration. Following the registration, the robotic arm will move on command according to the planned puncture trajectory and stop at a defined distance to the marked target point. The entry point is marked on the scalp along the puncture trajectory, then a scalp incision and burr-hole drilling will be performed. After penetrating the dura with unipolar electrocautery, a drainage tube will be gently inserted to the defined depth under the indication of the disinfected robotic arm. The liquefied hematoma will be withdrawn slowly by a 10 mL syringe.
Primary Outcome Measure Information:
Title
modified Rankin Scale (mRS) 0-2
Description
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.
Time Frame
180 days after surgery
Secondary Outcome Measure Information:
Title
Evacuation rate of HICH
Description
the ratio of effective volume reduction to the initial volume
Time Frame
at the first day after procedure, 30 days and 180 days during the follow-up period.
Title
modified Rankin Scale (mRS) 0-1
Description
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.
Time Frame
180 days after surgery
Title
between-group shift analysis in the mRS distribution
Description
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.
Time Frame
180 days after surgery
Title
Extended Glasgow Outcome Scale (eGOS)
Description
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.
Time Frame
at 90- and 180-days after surgery.
Title
NIH Stroke Scale（NIHSS）
Description
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
Time Frame
at 90- and 180-days after surgery.
Title
Barthel Index for Activities of Daily Living (ADL-BI)
Description
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.
Time Frame
at 90- and 180-days after surgery.
Title
Fugl-Meyer Assessment (FMA)
Description
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.
Time Frame
at 90- and 180-days after surgery.
Title
Motor Assessment Scale (MAS)
Description
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
Time Frame
at 90- and 180-days after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Hou, MD,PhD
Phone
+862181885671
Email
houlijun@smmu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rongbin Chen, MD,PhD
Phone
+862181885686
Email
crb2588@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijun Hou, MD,PhD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tao Xu, MD,PhD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage
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