Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

NCT ID: NCT06486480

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

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 strategy for intraventricular hemorrhage

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot assisted endoscopy group

Using robot assisted endoscopy to clear intraventricular hemorrhage

Group Type: EXPERIMENTAL

Using robot assisted endoscopy to clear intraventricular hemorrhage

Intervention Type: PROCEDURE

More advanced surgical auxiliary instruments are used to improve surgical accuracy

External ventricular drainage group

Using External ventricular drainage to clear intraventricular hemorrhage

Group Type: ACTIVE_COMPARATOR

Using robot assisted endoscopy to clear intraventricular hemorrhage

Intervention Type: PROCEDURE

More advanced surgical auxiliary instruments are used to improve surgical accuracy

Interventions

Using robot assisted endoscopy to clear intraventricular hemorrhage

More advanced surgical auxiliary instruments are used to improve surgical accuracy

Intervention Type: PROCEDURE

Other Intervention Names

External ventricular drainage

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jin Hu

OTHER

Sponsor Role: lead

Responsible Party

Jin Hu

Huashan Hospital, Fudan University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

HSSJWK202406

Identifier Type: -

Identifier Source: org_study_id