Status:
NOT_YET_RECRUITING
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Lead Sponsor:
Jin Hu
Conditions:
Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT06486480
Start Date
January 1 2025
End Date
December 31 2026
Last Update
July 3 2024
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