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

Naval Military Medical University (Second Military Medical University)

Status: Not yet enrolling

Conditions: Hypertensive Intracerebral Hemorrhage

Treatments: Procedure: Robotic Assisted Evacuation

Study type: Interventional

Funder types: Other

Identifiers

NCT04957862

RESCUE-CHAIN

Details and patient eligibility

About

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

Full 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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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428 participants in 2 patient groups

robotic assisted evacuation

Active Comparator group

Description:

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

Treatment:

Procedure: Robotic Assisted Evacuation

Concomitant care

No Intervention group

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.