Acute Hypertensive Cerebral Hemmorrhage Surgery (NET-OCEAN)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach; Procedure: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery

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.).

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lijun Hou, MD,PhD; Phone Number: 86 21 81885671; Email: houlijunsmmu@163.com
• Study Contact Backup: Name: Liang Zhao, MD,PhD; Phone Number: 86 21 81885686; Email: 15921509289@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Department of Neurosurgery, Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trans-frontal keyhole approach; After general anesthesia, the patient was placed in supine position with head frame fixed. A straight or arc incision was made in the hairline of the affected side. The incision was 3cm beside the midline. The length of the incision was about 4cm and the diameter of the bone window was about 2.5cm. According to the preoperative thin-layer CT scan, the dura mater and part of the cerebral cortex were cut, and the endoport and other hard channels were inserted. The incision reached 2 / 3 of the length of the hematoma along the direction parallel to the long axis of the hematoma, During the operation, mini aneurysms were clipped to close the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity. The external drainage tube led out the skin through the subcutaneous tunnel, and the dura was sutured.	Procedure: Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach; Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
Active Comparator: Trans-occipital keyhole approach; After general anesthesia, the patient was placed in prone position with head frame fixed. According to the preoperative thin-layer CT scan, the long axis of hematoma was perpendicular to the ground, and the occipital puncture point was found along the extension line of the long axis of hematoma. Taking the puncture point as the center, a straight or arc incision parallel to the sagittal sinus was taken. The length of the incision was about 4cm, and the diameter of the bone window was about 2.5cm, Endoport and other hard channels were inserted to reach 2 / 3 of the long diameter of the hematoma along the direction parallel to the long axis of the hematoma. Under the neuroendoscope, the hematoma was aspirated or resected in blocks. During the operation, mini aneurysm clamp was used to clamp the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; Peking Union Medical College Hospital; Beijing Tiantan Hospital; Huashan Hospital; First Affiliated Hospital of Fujian Medical University; Shengjing Hospital; Qianfoshan Hospital; Tianjin Medical University General Hospital; Second Affiliated Hospital of Soochow University; ShuGuang Hospital; First Affiliated Hospital of Harbin Medical University; The General Hospital of Eastern Theater Command

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: July 3, 2021
• First Submitted That Met QC Criteria: July 3, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: neuroendoscope; trans-occipital approach; Acute Hypertensive Cerebral Hemmorrhage; Low-drainage Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive
• Other Study ID Numbers: NET-OCEAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No