Hypertensive Intracerebral HemorrhageNET-OCEANNCT04957849
Acute Hypertensive Cerebral Hemmorrhage Surgery
A study testing The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery and Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach in people with Hypertensive Intracerebral Hemorrhage, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Hypertensive Intracerebral Hemorrhage
- What is being tested?
- The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery and Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery, Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
Official title: 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
Read the 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.).
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Being tested
- 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
- Keywords
- neuroendoscope, trans-occipital approach, Acute Hypertensive Cerebral Hemmorrhage, Low-drainage Surgery
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage SurgeryProcedure or 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 approachProcedure or surgery
Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
| Study group | Role | What they receive |
|---|---|---|
| Trans-frontal keyhole approach | Active comparator | 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. Receives: Procedure: Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach |
| Trans-occipital keyhole approach | Active comparator | 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. Receives: Procedure: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Hou Lijun, Shanghai Changzheng Hospital
- Investigators
- Lijun Hou, MD,PhD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957849
- Sponsor's protocol ID
- NET-OCEAN
- Acronym
- NET-OCEAN
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT04957849
- Acronym / sponsor ID
- NET-OCEAN / NET-OCEAN
- Conditions
- Hypertensive Intracerebral Hemorrhage
- Keywords
- neuroendoscope, trans-occipital approach, Acute Hypertensive Cerebral Hemmorrhage, Low-drainage Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- 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
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-frontal keyhole approach | Active comparator | Procedure: Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approachAfter 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. |
| Trans-occipital keyhole approach | Active comparator | Procedure: The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage SurgeryAfter 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. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage SurgeryThe Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery | Procedure or surgery | Trans-occipital keyhole approach |
| Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approachEndoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach | Procedure or surgery | Trans-frontal keyhole approach |
Primary outcome
Clinical remission rate
Time frame: 1 month postoperation
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun Hou, MD,PhD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery and Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach in people with Hypertensive Intracerebral Hemorrhage, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijun Hou, MD,PhD (86 21 81885671, houlijunsmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: 1 month postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.