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NCT Number: NCT06486480

Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Using robot assisted endoscopy to clear intraventricular hemorrhage

Procedure

More advanced surgical auxiliary instruments are used to improve surgical accuracy

Other names: External ventricular drainage

Primary outcomes

  1. 6-month mRS score

    Time frame: 180 days

    MRS Scores 6 months after onset

Secondary outcomes

  1. 30 day mortality rate

    Time frame: 0-30 days

    Mortality at 30 days after onset

Sponsors and collaborators

Lead sponsor

Jin Hu

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.