Not yet recruiting NCT06486480

Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

Early Phase I Interventional Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Using robot assisted endoscopy to clear intraventricular hemorrhage.
Who it may be relevant to: Registry conditions: Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

Procedure Using robot assisted endoscopy to clear intraventricular hemorrhage
More advanced surgical auxiliary instruments are used to improve surgical accuracy

Primary outcome measures

6-month mRS score [Time frame: 180 days]

Secondary outcome measures (1)

30 day mortality rate [Time frame: 0-30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06486480 · HSSJWK202406

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗