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Minimally invasive surgical strategy for robot-assisted ventricular hemorrhage

Minimally invasive surgical strategy for robot-assisted ventricular hemorrhage

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092867
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular hemorrhage

Interventions

robot-assisted endoscopic removal group:Robot assisted endoscopic removal of intraventricular hemorrhage
ventricular puncture external drainage group:ventricular puncture external drainage

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2.The time from onset to the first CT confirmed ventricular hemorrhage =8 points, and the sum of bilateral ventricular scores was =5 points; 4. If there is cerebral parenchymal hemorrhage but the hematoma volume < 30ml; 5. The time from the first CT to randomization < 48 hours; 6. The time from onset to operation < 72 hours; 7.GCS <=14.

Exclusion criteria

Exclusion criteria: 1. Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated cerebral aneurysm rupture, moyamoya disease, intracranial AVM rupture, or tumor; 2. Patients with a GCS score of 3 and/or fixed bipupil dilation and/or no spontaneous breathing; 3. Patients with pre-existing neurological diseases that affect neurological function assessment; 4.Coagulation dysfunction; 5.Patients requiring long-term anticoagulation therapy; 6.Use of dabigatran, apixaban, and/or rivaroxaban (or drugs of the same drug class) before the onset of symptoms; 7. Platelet count 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 who have participated in observational, natural history and/or epidemiological studies that do not involve the intervention are eligible; 11. Study participants who are not expected to survive to the Day 180 visit;

Design outcomes

Primary

MeasureTime frame
6-month mRS score;

Secondary

MeasureTime frame
Mortality at 6 months follow-up;Length of hospital stay for the patient;Length of stay in ICU;Ventricular hematoma clearance at 7 days postoperatively;Number of days of external ventricular drainage;Shunt dependent on the incidence of hydrocephalus;Adverse events and complication rates;

Countries

China

Contacts

Public ContactHu jin

Huashan Hospital, Fudan University

hujin_dana@126.com+86 21 6564 2662

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026