Status:
NOT_YET_RECRUITING
A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Affiliated Hospital of Nantong University
Conditions:
Hematoma Brain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The AI robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the ...
Detailed Description
In this randomized controlled study, we investigated the efficacy of robotic assistance for supratentorial large hematomas by comparing robotic-assisted minimally invasive removal of supratentorial la...
Eligibility Criteria
Inclusion
- Patients who were diagnosed by imaging (CT, CTA, etc.), measured by the ABC/2 method, and clearly recognized as having a supratentorial hypertensive cerebral hemorrhage.
- Patients with hematoma volume \>30mL and GCS score ≥5;
- The patient's age is 18-70 years old; Patients aged 18-70 years;
- Time from onset to surgery ≤72h;
- Repeat CT scan at least 6 hours after the diagnostic CT scan showed that the hematoma was stable;
- SBP \<180 mmHg was recorded near the time of random assignment;
- mRS score ≤1 in the past medical history;
- Patient/family informed and signed informed consent.
Exclusion
- The hematoma is not located on the curtain or the volume of the hematoma is less than 30 ml;
- The onset of the disease is more than 3 days at the time of admission; Secondary cerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism).
- secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, trauma, drug-related or abnormal coagulation mechanism);
- Presence of serious immune diseases (e.g., cirrhosis, malignant tumors, rheumatic immune diseases, etc.);
- Poor compliance or inappropriate for enrollment as judged by the investigator.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06484374
Start Date
January 1 2025
End Date
December 31 2027
Last Update
July 3 2024
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