StrokePhase 4NEMP-BGHNCT06924983
Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage
A Phase 4 study testing Simple neuroendoscopic hematoma evacuation and Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate in people with Stroke and Intracerebral Hemorrhage Basal Ganglia, run by Yong Jiang at 1 site in China.
Trial summary
The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Intracerebral Hemorrhage Basal Ganglia, Methylprednisolone
- What is being tested?
- Simple neuroendoscopic hematoma evacuation and Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years old.
- Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
- Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A * B * C * 1/2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.
- The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
- The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
- The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.
- The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.
- The patient and their legal representative should sign a written informed consent form.
Who cannot join
- Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).
- Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
- Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
- A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.
- Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
- Platelet count < 75 × 10⁹/L.
Show all 19Show fewer
- Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) > 1.4.
- Expected to require long-term anticoagulation and antiplatelet therapy.
- A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled.
- Myocardial infarction occurred within the recent 30 days.
- Known to have a high embolism risk, including patients with mechanical heart valves implanted in the body, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible.
- Severe liver function impairment, with alanine aminotransferase (ALT) > 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) > 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate < 30 ml/min/1.73 m².
- Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.
- Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc.
- Allergic to drugs or devices related to the operation.
- Pregnant or lactating women, or those planning to become pregnant within one year.
- In the terminal stage of any disease with an expected lifespan of less than 6 months.
- Currently participating in other clinical trials or having been previously enrolled in this trial.
- The patient or his/her legal guardian is unwilling to sign the written informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Southwest Medical University
Luzhou, China, 646000
Jianhua Peng, MD, 8615228285418, pengjianhua@swmu.edu.cn
About this study
Official title: A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage.
The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.
Read the detailed description
There is still a lack of the best evidence-based reference for the treatment of basal ganglia intracerebral hemorrhage. The ENRICH trial published in 2024 demonstrated that minimally invasive hematoma evacuation might have a better clinical prognosis than standard medical treatment in patients with spontaneous intracerebral hemorrhage. However, the significant effect of the surgery might be mainly attributed to the intervention in patients with basal ganglia hemorrhage. Besides, simply relying on surgical removal of hematoma may not be sufficient to significantly improve the long-term prognosis of patients. How to effectively control secondary brain injury, reduce cerebral edema and inflammatory response is the key to improving the prognosis of patients with basal ganglia intracerebral hemorrhage. Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate brain injury. The results of the MARVEL trial released in 2024 showed that methylprednisolone sodium succinate has demonstrated the potential to reduce the incidence of secondary intracerebral hemorrhage (ICH) and mortality in patients with acute ischemic stroke.
This study aims to systematically evaluate the efficacy and safety of neuroendoscopic hematoma evacuation combined with the early use of methylprednisolone sodium succinate in patients with basal ganglia intracerebral hemorrhage through a multicenter, prospective, randomized controlled clinical trial. The study will compare the differences in main endpoint indicators such as functional independence, quality of life and survival rate at 3 months and 6 months after surgery between the group receiving surgical treatment combined with methylprednisolone sodium succinate and the group receiving surgical treatment alone, so as to explore the impact of different treatment strategies on the prognosis of patients with basal ganglia intracerebral hemorrhage.
- Being tested
- Simple neuroendoscopic hematoma evacuation, Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple neuroendoscopic hematoma evacuationProcedure or surgery
For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed
Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinateCombination product
For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, they will be treated with the combination of neuroendoscopic hematoma evacuation and sodium methylprednisolone succinate. Administer sodium methylprednisolone succinate for injection by intravenous injection 6 hours after the onset of the disease. Specific administration: Intravenous injection at a dosage of 2 mg/kg, once daily, for three consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| The neuroendoscopic treatment group | Active comparator | For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, simple neuroendoscopic hematoma evacuation was performed. Receives: Procedure: Simple neuroendoscopic hematoma evacuation |
| The methylprednisolone sodium succinate combined with neuroendoscopic treatment group | Experimental | For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, neuroendoscopic hematoma evacuation combined with methylprednisolone sodium succinate treatment was carried out. Receives: Combination Product: Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale score (mRS)
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
Measured: 180 days
The mortality rate
evaluate death rate of the two treatment groups
Measured: 30 days
Secondary outcomes (12)
Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)
excellent outcome
Measured: 180 days
Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)
functional independence
Measured: 180 days
Proportion of patients ambulatory or bodily needs-capable or better (Modified Rankin scale score (mRS) 0 to 3)
ambulatory or bodily needs-capable or better
Measured: 180 days
Change in National Institute of Health stroke scale (NIHSS) score between baseline and 7~10d or at discharge
neurological changes. The scoring range is from 0 to 42 points. The higher the score is, the more severe the degree of neurological impairment in patients will be.
Measured: 7~10 days or at discharge
Change in Glasgow Coma Scale(GCS) between baseline and 7~10d or at discharge
evaluate the state of consciousness. The scoring range is from 3 to 15 points. The lower the score is, the worse the patient's conscious state will be.
Measured: 7~10 days or at discharge
Improvement in residual hematoma volume between baseline and 7d or at discharge
Measured: 7~10 days or at discharge
Barthel Index Score(BI)
evaluate the Activities of Daily Living.The scoring range is from 0 to 100 points. The lower the score is, the poorer the patient's activities of daily living ability will be.
Measured: 180 days
European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Health-related quality of life. The scoring range is from 5 to 25 points. The higher the score is, the poorer the patient's health-related quality of life will be.
Measured: 180 days
Mortality within 7 days randomly or at discharge
evaluate death rate of the two treatment groups
Measured: 7days or at discharge
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Measured: within 30 days after randomized
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Measured: within 180 days after randomized
severe adverse events
evaluate complications and any adverse events
Measured: within 180 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Jiang, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924983
- Sponsor's protocol ID
- 2025135
- Acronym
- NEMP-BGH
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 13 Apr 2025
- 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage.
- ClinicalTrials.gov ID
- NCT06924983
- Acronym / sponsor ID
- NEMP-BGH / 2025135
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yong JiangUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Apr 2025 (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 aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.
Detailed description
There is still a lack of the best evidence-based reference for the treatment of basal ganglia intracerebral hemorrhage. The ENRICH trial published in 2024 demonstrated that minimally invasive hematoma evacuation might have a better clinical prognosis than standard medical treatment in patients with spontaneous intracerebral hemorrhage. However, the significant effect of the surgery might be mainly attributed to the intervention in patients with basal ganglia hemorrhage. Besides, simply relying on surgical removal of hematoma may not be sufficient to significantly improve the long-term prognosis of patients. How to effectively control secondary brain injury, reduce cerebral edema and inflammatory response is the key to improving the prognosis of patients with basal ganglia intracerebral hemorrhage. Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate brain injury. The results of the MARVEL trial released in 2024 showed that methylprednisolone sodium succinate has demonstrated the potential to reduce the incidence of secondary intracerebral hemorrhage (ICH) and mortality in patients with acute ischemic stroke.
This study aims to systematically evaluate the efficacy and safety of neuroendoscopic hematoma evacuation combined with the early use of methylprednisolone sodium succinate in patients with basal ganglia intracerebral hemorrhage through a multicenter, prospective, randomized controlled clinical trial. The study will compare the differences in main endpoint indicators such as functional independence, quality of life and survival rate at 3 months and 6 months after surgery between the group receiving surgical treatment combined with methylprednisolone sodium succinate and the group receiving surgical treatment alone, so as to explore the impact of different treatment strategies on the prognosis of patients with basal ganglia intracerebral hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The neuroendoscopic treatment group | Active comparator | Procedure: Simple neuroendoscopic hematoma evacuationFor patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, simple neuroendoscopic hematoma evacuation was performed. |
| The methylprednisolone sodium succinate combined with neuroendoscopic treatment group | Experimental | Combination Product: Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinateFor patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, neuroendoscopic hematoma evacuation combined with methylprednisolone sodium succinate treatment was carried out. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 80 years old.
- Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
- Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A * B * C * 1/2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.
- The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
- The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
Key exclusion criteria (19 listed)
- Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).
- Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
- Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
- A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.
- Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
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 |
|---|---|---|
| Simple neuroendoscopic hematoma evacuationFor patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed | Procedure or surgery | The neuroendoscopic treatment group |
| Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinateFor patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, they will be treated with the combination of neuroendoscopic hematoma evacuation and sodium methylprednisolone succinate. Administer sodium methylprednisolone succinate for injection by intravenous injection 6 hours after the onset of the disease. Specific administration: Intravenous injection at a dosage of 2 mg/kg, once daily, for three consecutive days. | Combination product | The methylprednisolone sodium succinate combined with neuroendoscopic treatment group |
Primary outcome
Modified Rankin scale score (mRS)
Time frame: 180 days
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
The mortality rate
Time frame: 30 days
evaluate death rate of the two treatment groups
12 secondary outcomes
Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)
Time frame: 180 days
Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)
Time frame: 180 days
Proportion of patients ambulatory or bodily needs-capable or better (Modified Rankin scale score (mRS) 0 to 3)
Time frame: 180 days
Change in National Institute of Health stroke scale (NIHSS) score between baseline and 7~10d or at discharge
Time frame: 7~10 days or at discharge
Change in Glasgow Coma Scale(GCS) between baseline and 7~10d or at discharge
Time frame: 7~10 days or at discharge
Improvement in residual hematoma volume between baseline and 7d or at discharge
Time frame: 7~10 days or at discharge
Barthel Index Score(BI)
Time frame: 180 days
European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Time frame: 180 days
Mortality within 7 days randomly or at discharge
Time frame: 7days or at discharge
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Time frame: within 30 days after randomized
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Time frame: within 180 days after randomized
severe adverse events
Time frame: within 180 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simple neuroendoscopic hematoma evacuation and Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate in people with Stroke and Intracerebral Hemorrhage Basal Ganglia, run by Yong Jiang 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 8 inclusion and 19 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: opening soon, as of the sponsor's last update on 13 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Jiang, MD (8613608280599, jiangyong@swmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale score (mRS) (time frame: 180 days). The study lists 2 primary outcomes in all. 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 13 Apr 2025.