Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Robot assisted endoscopy group
Using robot assisted endoscopy to clear intraventricular hemorrhage
|
More advanced surgical auxiliary instruments are used to improve surgical accuracy
Other Names:
|
|
Active Comparator: External ventricular drainage group
Using External ventricular drainage to clear intraventricular hemorrhage
|
More advanced surgical auxiliary instruments are used to improve surgical accuracy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-month mRS score
Time Frame: 180 days
|
MRS Scores 6 months after onset
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 day mortality rate
Time Frame: 0-30 days
|
Mortality at 30 days after onset
|
0-30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSSJWK202406
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.