Hypertensive Intracerebral HemorrhageNCT04957862
Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage
A study testing Robotic Assisted Evacuation in people with Hypertensive Intracerebral Hemorrhage, run by Shanghai Changzheng Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertensive Intracerebral Hemorrhage
- What is being tested?
- Robotic Assisted Evacuation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet.
About this study
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
Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial
Read the 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.
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Being tested
- Robotic Assisted Evacuation
- Keywords
- Randomized controlled trial, Hypertensive Intracerebral Hemorrhage, subacute, chronic, robotic assisted evacuation, function rehabilitation
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted EvacuationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| robotic assisted evacuation | Active comparator | In the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia. Receives: Procedure: Robotic Assisted Evacuation |
| Concomitant care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days after surgery
Secondary outcomes (8)
Evacuation rate of HICH
the ratio of effective volume reduction to the initial volume
Measured: at the first day after procedure, 30 days and 180 days during the follow-up period.
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.
Measured: 180 days after surgery
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.
Measured: 180 days after surgery
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.
Measured: at 90- and 180-days after surgery.
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
Measured: at 90- and 180-days after surgery.
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.
Measured: at 90- and 180-days after surgery.
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.
Measured: at 90- and 180-days after surgery.
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
Measured: at 90- and 180-days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, 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 Shenzhen 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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shenzhen People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 6th People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, 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
- Responsible party
- Principal investigator, Hou Lijun, Shanghai Changzheng Hospital
- Investigators
- Lijun Hou, MD,PhD, Principal investigator, Shanghai Changzheng HospitalTao Xu, MD,PhD, Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957862
- Sponsor's protocol ID
- RESCUE-CHAIN
- Status last verified
- Aug 2022
- First submitted
- 3 Jul 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04957862
- Acronym / sponsor ID
- RESCUE-CHAIN
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Keywords
- Randomized controlled trial, Hypertensive Intracerebral Hemorrhage, subacute, chronic, robotic assisted evacuation, function rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, 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 Shenzhen 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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shenzhen People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 6th People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, 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
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic assisted evacuation | Active comparator | Procedure: Robotic Assisted EvacuationIn the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia. |
| Concomitant care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted EvacuationOn 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. | Procedure or surgery | robotic assisted evacuation |
Primary outcome
modified Rankin Scale (mRS) 0-2
Time frame: 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.
8 secondary outcomes
Evacuation rate of HICH
Time frame: at the first day after procedure, 30 days and 180 days during the follow-up period.
modified Rankin Scale (mRS) 0-1
Time frame: 180 days after surgery
between-group shift analysis in the mRS distribution
Time frame: 180 days after surgery
Extended Glasgow Outcome Scale (eGOS)
Time frame: at 90- and 180-days after surgery.
NIH Stroke Scale（NIHSS）
Time frame: at 90- and 180-days after surgery.
Barthel Index for Activities of Daily Living (ADL-BI)
Time frame: at 90- and 180-days after surgery.
Fugl-Meyer Assessment (FMA)
Time frame: at 90- and 180-days after surgery.
Motor Assessment Scale (MAS)
Time frame: at 90- and 180-days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun Hou, MD,PhD principal investigator
Shanghai Changzheng Hospital
Tao Xu, MD,PhD study director
Shanghai Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted Evacuation in people with Hypertensive Intracerebral Hemorrhage, run by Shanghai Changzheng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijun Hou, MD,PhD (+862181885671, houlijun@smmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) 0-2 (time frame: 180 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.