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Acute Hypertensive Cerebral Hemmorrhage Surgery (NET-OCEAN)

Primary Purpose

Hypertensive Intracerebral Hemorrhage

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Intracerebral Hemorrhage focused on measuring neuroendoscope, trans-occipital approach, Acute Hypertensive Cerebral Hemmorrhage, Low-drainage Surgery

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurosurgery, Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trans-frontal keyhole approach

Trans-occipital keyhole approach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2021
Last Updated
July 3, 2021
Sponsor
Shanghai Changzheng Hospital
Collaborators
Beijing Tiantan Hospital, Huashan Hospital, Tianjin Medical University General Hospital, First Affiliated Hospital of Fujian Medical University, Peking Union Medical College Hospital, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Nanchang University, The General Hospital of Eastern Theater Command, First Affiliated Hospital of Harbin Medical University, Shengjing Hospital, ShuGuang Hospital, Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04957849
Brief Title
Acute Hypertensive Cerebral Hemmorrhage Surgery
Acronym
NET-OCEAN
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
Beijing Tiantan Hospital, Huashan Hospital, Tianjin Medical University General Hospital, First Affiliated Hospital of Fujian Medical University, Peking Union Medical College Hospital, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Nanchang University, The General Hospital of Eastern Theater Command, First Affiliated Hospital of Harbin Medical University, Shengjing Hospital, ShuGuang Hospital, Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Intracerebral Hemorrhage
Keywords
neuroendoscope, trans-occipital approach, Acute Hypertensive Cerebral Hemmorrhage, Low-drainage Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trans-frontal keyhole approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trans-occipital keyhole approach
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery
Intervention Description
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
Intervention Description
Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
Primary Outcome Measure Information:
Title
Clinical remission rate
Description
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.
Time Frame
1 month postoperation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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)). Head CT showed; hematoma volume ≥ 30ml, intraventricular hemorrhage is not counted as hemorrhage volume. Time from onset to hospital admission ≤8h. The age of the patient is 15-75 years old. Glasgow Coma Score (GCS)> 5 points. The patient/family knows and signs the informed consent form. Have a clear history of hypertension in the past. Exclusion Criteria: Bleeding caused by aneurysm, vascular malformation or tumor stroke. Combined with a history of head injury or trauma. There is more blood in the skull. Past mental disorders or neurological dysfunction. A history of procoagulant dysfunction or anticoagulant drugs. Patients with complications such as liver and kidney dysfunction. Those with poor compliance. Pregnant patients. 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. With late-stage cerebral herniation (bilateral dilated pupils, central respiratory and circulatory failure). Severe cardiovascular and cerebrovascular diseases: such as myocardial infarction, cerebral infarction, coronary heart disease, myocarditis, malignant arrhythmia, etc. Participate in other clinical research 3 months before enrollment. The doctor in charge believes that the study plan cannot be followed. Those who are or plan to become pregnant or breastfeeding. Those who are known to be allergic to test drugs or related products.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Hou, MD,PhD
Phone
86 21 81885671
Email
houlijunsmmu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Zhao, MD,PhD
Phone
86 21 81885686
Email
15921509289@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijun Hou, MD,PhD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Hypertensive Cerebral Hemmorrhage Surgery

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