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A Multi-Center Randomized Controlled Clinical Study of MRI Navigation, Neuroendoscopy and Wise Information Technology of Med Combined with Minimally Invasive Surgery in the Treatment of Cerebral Hemorrhage

A Multi-Center Randomized Controlled Clinical Study of MRI Navigation, Neuroendoscopy and Wise Information Technology of Med Combined with Minimally Invasive Surgery in the Treatment of Cerebral Hemorrhage

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045925
Enrollment
Unknown
Registered
2021-04-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage

Interventions

Group A:internal medicine
Group B:MRI navigation+minimally invasive surgery
Group C:neuroendoscopy+minimally invasive surgery
Group D:AR+AI+minimally invasive surgery

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. GCS = 6; 3. Spontaneous supratentorial hemorrhage >= 30ml; 4. Within 12 hours after symptoms onset; 5. Willing to receive minimally invasive surgery within 48 hours after ICH; 6. Hematoma volume increase<=5 ml after 6 hours; 7. Systolic pressure < 200 mmHg and lasted for at least 6 hours; 8. Modified Rankin Scale scored 0 or 1 before ICH; 9. Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. ICH in brainstem; 2. platelet 1.4; 3. Patients with coagulopathy; 4. Accompanied by serious diseases, including liver disease, kidney disease, digestive system, cardiovascular system, respiratory system, endocrine system, blood system, immune system, etc.; 5. Mechanical valve implantation; 6. Unstable intracranial space occupying or progressive intracranial hypertension syndrome; 7. Irreversible brain stem failure (fixation of eyeball, dilation of pupil, decancephalization, etc.) or Glasgow coma scale <= 4; 8. Included in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Sequential analysis of Modified-Rankin-Scale scores;

Secondary

MeasureTime frame
Death or disability (Modified Rankin Scale scored 3-6);

Countries

China

Contacts

Public ContactYang Liusong, Tang Yuping

Huashan Hospital, Fudan University

tangyuping39@hotmial.com+86 21 52889999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026