NCT04957862

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

July 3, 2021

Last Update Submit

August 7, 2022

Conditions

Hypertensive Intracerebral Hemorrhage

Keywords

Randomized controlled trialHypertensive Intracerebral Hemorrhagesubacutechronicrobotic assisted evacuationfunction rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Evacuation rate of HICH

    at the first day after procedure, 30 days and 180 days during the follow-up period.

  • modified Rankin Scale (mRS) 0-1

    180 days after surgery

  • between-group shift analysis in the mRS distribution

    180 days after surgery

  • Extended Glasgow Outcome Scale (eGOS)

    at 90- and 180-days after surgery.

  • NIH Stroke Scale（NIHSS）

    at 90- and 180-days after surgery.

  • +3 more secondary outcomes

Study Arms (2)

robotic assisted evacuation

ACTIVE COMPARATOR

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

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.

Interventions

Robotic Assisted EvacuationPROCEDURE

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.

robotic assisted evacuation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Hemorrhage, HypertensiveBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Lijun Hou, MD,PhD

    Shanghai Changzheng Hospital

    PRINCIPAL INVESTIGATOR

  • Tao Xu, MD,PhD

    Shanghai Changzheng Hospital

    STUDY DIRECTOR

Central Study Contacts

Lijun Hou, MD,PhD

CONTACT

+862181885671houlijun@smmu.com

Rongbin Chen, MD,PhD

CONTACT

+862181885686crb2588@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 12, 2021

Study Start

September 1, 2022

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share