Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

Early Phase 1

Not yet recruiting

• Conditions: Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag
• Interventions: Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

• Registration Number: NCT06486480
• Lead Sponsor: Jin Hu

Brief Summary

Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• Age range from 18 to 80 years old;

  • The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;

    • Before enrollment, CT confirmed that the intraventricular hemorrhage score (modified Graeb score) was ≥ 8 points, and the total score of bilateral lateral ventricles was ≥ 5 points;

      • If there is concurrent cerebral hemorrhage but the hematoma volume is less than 30ml;

        ⑤ First CT to surgery time<72 hours;

        ⑥ GCS ≤ 14.

Exclusion Criteria

• ① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;

  • Patients with a GCS score of 3 and/or fixed dilated pupils and/or no spontaneous breathing;

    • Patients with pre-existing neurological disorders that affect neurological function assessment prior to onset;

      • Coagulation dysfunction;

        • Patients who require long-term anticoagulant treatment;

          ⑥ Use dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptoms appear; ⑦ Platelet count<100 × 109/L, INR>1.4;

          ⑧ Pregnancy (positive serum or urine pregnancy test);

          ⑨ Subtentorial hemorrhage or brainstem hemorrhage;

          ⑩ Patients who have previously participated in other interventional clinical studies and participated in observational, natural history, and/or epidemiological studies that do not involve intervention are eligible;

          ⑪ Subjects who are expected to not survive until the 180th day of visit; No written informed consent was given by the subjects or legal representatives.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External ventricular drainage group	Using robot assisted endoscopy to clear intraventricular hemorrhage	Using External ventricular drainage to clear intraventricular hemorrhage
Robot assisted endoscopy group	Using robot assisted endoscopy to clear intraventricular hemorrhage	Using robot assisted endoscopy to clear intraventricular hemorrhage

Primary Outcome Measures

Name	Time	Method
6-month mRS score	180 days	MRS Scores 6 months after onset

Secondary Outcome Measures

Name	Time	Method
30 day mortality rate	0-30 days	Mortality at 30 days after onset