Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

NCT06486480 | Not Yet Recruiting Early Phase 1

• 1 other identifier: HSSJWK202406
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 6-month mRS score

  MRS Scores 6 months after onset

  180 days

Secondary Outcomes (1)

• 30 day mortality rate

  0-30 days

Study Arms (2)

Robot assisted endoscopy group

EXPERIMENTAL

Using robot assisted endoscopy to clear intraventricular hemorrhage

Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

External ventricular drainage group

ACTIVE COMPARATOR

Using External ventricular drainage to clear intraventricular hemorrhage

Procedure: Using robot assisted endoscopy to clear intraventricular hemorrhage

Interventions

Using robot assisted endoscopy to clear intraventricular hemorrhage PROCEDURE

More advanced surgical auxiliary instruments are used to improve surgical accuracy

Also known as: External ventricular drainage

External ventricular drainage group; Robot assisted endoscopy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Hu: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Huashan Hospital, Fudan University

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06