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

Hypertensive Intracerebral Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04957862
• Other study ID #: RESCUE-CHAIN
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2022
• Source: Shanghai Changzheng Hospital
• Contact: Lijun Hou, MD,PhD
• Phone: +862181885671
• Email: houlijun[@]smmu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 428
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertensive Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive

Intervention

Procedure:
• Robotic Assisted Evacuation
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.

Locations

Country	Name	City	State
n/a

Sponsors (27)

Lead Sponsor

Collaborator

Shanghai Changzheng Hospital

Affiliated Hospital of Chifeng University, Anhui No.2 Provincial People's Hospital, Beijing Tian Tan Hospital Affiliated to Capital Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Wenzhou Medical University, Fujian Provincial Hospital, General Hospital of Ningxia Medical University, Haikou People's Hospital, Huazhong University of Science and Technology Union Hospital (Nanshan Hospital), Jinjiang Hospital of Traditional Chinese Medicine, LanZhou University, Peking Union Medical College Hospital, Qian Xi Nan People's Hospital, Qilu Hospital of Shandong University, Renmin Hospital of Wuhan University, Sanhe Yanjiao People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shaanxi Provincial People's Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen People's Hospital, South Taihu Hospital of Huzhou, Tang-Du Hospital, Tianjin Medical University General Hospital, Wuhan Union Hospital, China, Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	180 days after surgery
Secondary	Evacuation rate of HICH	the ratio of effective volume reduction to the initial volume	at the first day after procedure, 30 days and 180 days during the follow-up period.
Secondary	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.	180 days after surgery
Secondary	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.	180 days after surgery
Secondary	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.	at 90- and 180-days after surgery.
Secondary	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	at 90- and 180-days after surgery.
Secondary	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.	at 90- and 180-days after surgery.
Secondary	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.	at 90- and 180-days after surgery.
Secondary	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	at 90- and 180-days after surgery.