Clinical trial NCT04957849: Acute Hypertensive Cerebral Hemmorrhage Surgery
Official title: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertensive Intracerebral Hemorrhage
Keywords: neuroendoscope
trans-occipital approach
Acute Hypertensive Cerebral Hemmorrhage
Low-drainage Surgery
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Huashan Hospital
name: Tianjin Medical University General Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Peking Union Medical College Hospital
name: Second Affiliated Hospital of Soochow University
name: The First Affiliated Hospital of Nanchang University
name: The General Hospital of Eastern Theater Command
name: First Affiliated Hospital of Harbin Medical University
name: Shengjing Hospital
name: ShuGuang Hospital
name: Qianfoshan Hospital
First posted: 2021-07-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial

Detailed description: To evaluate the effect of different surgical approaches on the prognosis of patients with hypertensive intracerebral hemorrhage, hypertensive patients who met the diagnostic criteria of American guidelines for the treatment of adult spontaneous intracerebral hemorrhage (2015) were selected. The time from onset to admission was less than 8 hours. Blood routine examination, liver and kidney function, coagulation system, infectious diseases and other examinations were performed before operation, with emergency surgical indications, They were divided into two groups: transfrontal keyhole approach and transoccipital keyhole approach. Emergency endoscopic hematoma removal was performed. The patients were systematically evaluated and followed up at 1 week, 1 month, 3 months, 6 months and 12 months after operation to observe the improvement of consciousness, GCS score, postoperative rebleeding (appearance, bleeding volume, location, broken into ventricle, etc.), The prognosis was evaluated by ADL score, GCS score, gos score, modified Rankin scale, Mrs scale and ICH Score (GCS, hematoma volume, intraventricular hemorrhage, infratentorial source, patient age, etc.).

Eligibility criteria: Inclusion Criteria:

1. Diagnosed patients with spontaneous cerebral hemorrhage in the basal ganglia (in line with the diagnostic criteria of the American Adult Spontaneous Cerebral Hemorrhage Treatment Guidelines (2015)).
2. Head CT showed; hematoma volume ≥ 30ml, intraventricular hemorrhage is not counted as hemorrhage volume.
3. Time from onset to hospital admission ≤8h.
4. The age of the patient is 15-75 years old.
5. Glasgow Coma Score (GCS)\> 5 points.
6. The patient/family knows and signs the informed consent form.
7. Have a clear history of hypertension in the past.

Exclusion Criteria:

1. Bleeding caused by aneurysm, vascular malformation or tumor stroke.
2. Combined with a history of head injury or trauma.
3. There is more blood in the skull.
4. Past mental disorders or neurological dysfunction.
5. A history of procoagulant dysfunction or anticoagulant drugs.
6. Patients with complications such as liver and kidney dysfunction.
7. Those with poor compliance.
8. Pregnant patients.
9. With massive hemorrhage of the ventricle (the area of the hematoma in the CT side is larger than 1/2 of the transverse section), hemorrhage in the third and fourth ventricles with enlarged ventricles.
10. With late-stage cerebral herniation (bilateral dilated pupils, central respiratory and circulatory failure).
11. Severe cardiovascular and cerebrovascular diseases: such as myocardial infarction, cerebral infarction, coronary heart disease, myocarditis, malignant arrhythmia, etc.
12. Participate in other clinical research 3 months before enrollment.
13. The doctor in charge believes that the study plan cannot be followed.
14. Those who are or plan to become pregnant or breastfeeding.
15. Those who are known to be allergic to test drugs or related products.

Primary outcomes:
measure: Clinical remission rate
timeFrame: 1 month postoperation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Lijun Hou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: