Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

Jin Hu

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag

Treatments

Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

Study type

Interventional

Funder types

Other

Identifiers

NCT06486480

HSSJWK202406

Details and patient eligibility

About

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

Enrollment

143 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.