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

• 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

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