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Clinical study on the efficacy and safety of neurosurgical robot in the treatment of severe hypertensive brain stem hemorrhage

Clinical study on the efficacy and safety of neurosurgical robot in the treatment of severe hypertensive brain stem hemorrhage

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053458
Enrollment
Unknown
Registered
2021-11-21
Start date
2021-11-15
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Brainstem hemorrhage

Interventions

experimental group:Stereotactic puncture aspiration by neurosurgical robot

Sponsors

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed patients with primary PPH: The diagnostic criteria included a clear history of hypertension, head CT indicated that the hematoma was located in the pontine brain, which could extend to the midbrain or medulla oblongata, and the hematoma could break into the third or fourth ventricle, which could be accompanied by obstructive hydrocephalus; 2. The amount of hematoma in brain stem parenchyma >=5ml was calculated by head CT (intraventricular hemorrhage was not included in the amount of bleeding); 3. Preoperative Glasgow coma score <8; 4. Time from onset to admission <=48 hours; 5. 18-75 years old.

Exclusion criteria

Exclusion criteria: 1. Cerebrovascular diseases include intracranial aneurysms, arteriovenous malformations, and cavernous vascular malformations; 2. Brainstem hemorrhage caused by tumor stroke; 3. Those with a history of coagulation dysfunction or anticoagulant drugs that cannot be corrected in the short term; 4. Combined with advanced brain herniation (bilateral mydriasis is fixed, no spontaneous breathing, blood pressure cannot be maintained); 5. Patients with liver and kidney failure or combined with systemic malignant tumors, and the expected survival period is less than 1 year; 6. History of mental disorder or neurological dysfunction in the past; 7. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
Rebleeding rate;mortality rate and intracranial infection rate;Modified Rankin scoring Scale;National Institutes of Health Stroke Scale;Glasgow Outcome Scale;Quality of Life (ED-5Q score);Quality of Life Self-rating scale;

Countries

China

Contacts

Public ContactNiu Chaoshi

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

niuchaoshi@USTC.edu.cn+86 13855186208

Outcome results

None listed

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