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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-06-30

Brief Summary

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

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Detailed Description

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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

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Hypertensive Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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robotic assisted evacuation

In the intervention arm, patients will receive stereotactic robotic assisted HICH evacuation according to the protocol under general anesthesia.

Group Type ACTIVE_COMPARATOR

Robotic Assisted Evacuation

Intervention Type PROCEDURE

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.

Concomitant care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No