Acute Hypertensive Cerebral Hemmorrhage Surgery

Hypertensive Intracerebral Hemorrhage Clinical Trial

— NET-OCEAN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04957849
• Other study ID #: NET-OCEAN
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2021
• Source: Shanghai Changzheng Hospital
• Contact: Lijun Hou, MD,PhD
• Phone: 86 21 81885671
• Email: houlijunsmmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertensive Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive

Intervention

Procedure:
• The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery
• Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach

Locations

Country	Name	City	State
China	Department of Neurosurgery, Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

Shanghai Changzheng Hospital

Beijing Tiantan Hospital, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Harbin Medical University, Huashan Hospital, Peking Union Medical College Hospital, Qianfoshan Hospital, Second Affiliated Hospital of Soochow University, Shengjing Hospital, ShuGuang Hospital, The First Affiliated Hospital of Nanchang University, The General Hospital of Eastern Theater Command, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission rate	The evaluation criteria of complete remission: more than 85% of intracranial hematoma was cleared, mild brain edema, and the postoperative hospital stay was less than 2 weeks. The evaluation criteria of partial remission: the clearance rate of intracranial hematoma was 60% - 85%, the postoperative brain edema was obvious, and the postoperative hospital stay was less than 4 weeks.	1 month postoperation