Intraventricular HemorrhageLD-IVHNCT07625449
Early Lumbar Drainage for Intraventricular Hemorrhage
A study of Intraventricular Hemorrhage and Cerebral Hemorrhage, run by Second Affiliated Hospital of Nanchang University at 31 sites in China.
Trial summary
This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial in Chinese patients with intraventricular hemorrhage (IVH), comparing early lumbar drainage added to standard care with standard care alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intraventricular Hemorrhage, Cerebral Hemorrhage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 31 sitesChina
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years, of either sex.
- First-ever intracerebral hemorrhage (ICH) with CT-confirmed hemorrhage involving the third and/or fourth ventricle, and scheduled to undergo or already having undergone burr-hole ventricular drainage.
- Intraparenchymal hemorrhage volume <30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization.
- Randomization completed within 72 hours of symptom onset.
- Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities).
- Written informed consent obtained from the participant or a legal guardian.
Who cannot join
- Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor.
- Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase.
- Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal.
- Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site).
- Infratentorial hemorrhage with a volume ≥10 mL.
- Thalamic hemorrhage with a volume ≥10 mL, or accompanied by obvious extension into the midbrain, oculomotor nerve palsy, or fixed and dilated non-reactive pupils.
Show all 14Show fewer
- Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization.
- Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts.
- Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency.
- Expected survival of less than 6 months due to other causes.
- Other coexisting severe diseases that are difficult to treat.
- Pregnancy.
- Participation in another interventional clinical trial within 30 days before randomization.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites
Changde First People's Hospital
Changde
Changde First People's Hospital, 936483206@qq.com
Lingcheng District People's Hospital
Dezhou
weifawei35888999@163.com
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou
xushugang82@163.com
Fuzhou First People's Hospital
Fuzhou, Jiangxi
Fuzhou First People's Hospital, yaoguojun1981@163.com
Ganzhou People's Hospital
Ganzhou
Ganzhou People's Hospital, yexinyun1270@163.com
Ruijin People's Hospital
Ganzhou
Manchang Liu, +8615970036188, 61730146@qq.com
The First Affiliated Hospital of Gannan Medical University
Ganzhou
The First Affiliated Hospital of Gannan Medical University, zzbbchina@126.com
The Affiliated Hospital of Guizhou Medical University
Guiyang
The Affiliated Hospital of Guizhou Medical University, yhmed@163.com
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital of Zhejiang University School of, gujun66@163.com
The First Affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of Anhui Medical University, chenjunhui101@163.com
Ji'an Central People's Hospital
Ji’an
Ji'an Central People's Hospital, Yjp8259309@163.com
Jinan Central Hospital
Jinan, Shandong
Song Li, +8618761196261, doctorlisong@126.com
Jingdezhen Second People's Hospital
Jingdezhen
Jingdezhen Second People's Hospital, 280960834@qq.com
Jiujiang First People's Hospital
Jiujiang
Jiujiang First People's Hospital, 40616665@qq.com
The First People's Hospital of Xiushui County
Jiujiang
The First People's Hospital of Xiushui County, lhb1062@163.com
The Second Hospital of Lanzhou University
Lanzhou
The Second Hospital of Lanzhou University, stone19871128@163.com
Linyi People's Hospital
Linyi
Linyi People's Hospital, drguofeng@163.com
The Affiliated Hospital of Southwest Medical University
Luzhou
The Affiliated Hospital of Southwest Medical University, yhmed@163.com
Nanchang Central Hospital
Nanchang
Nanchang Central Hospital, 1641853901@qq.com
Second Affiliated Hospital of Nanchang University
Nanchang
Ping Hu, +8613097286794, hp666edu@163.com
Panzhihua Central Hospital
Panzhihua
32406201@qq.com
Taihe Hospital
Shiyan
Taihe Hospital, 68108261@qq.com
The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Suzhou
The 904th Hospital of the Joint Logistics Support Force of the, chenjunhui1019@163.com
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Zhixin Zhao, +8617280677109, caiyj10982@enzemed.com
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Hansong Sheng, +8613587782218, shs951052@163.com
Yichang Central People's Hospital
Yichang
Yichang Central People's Hospital, onedy@sina.com
Zhangshu People's Hospital
Yichun
Zhangshu People's Hospital, 33309779@qq.com
Yingtan People's Hospital
Yingtan
Yingtan People's Hospital, 20030182@163.com
Zhangjiagang First People's Hospital
Zhangjiagang
Zhangjiagang First People's Hospital, zhangli_syy@163.com
Zhoukou Central Hospital
Zhoukou
Zhoukou Central Hospital, 96978849@qq.com
Zunyi First People's Hospital
Zunyi
Zunyi First People's Hospital, 136166618@qq.com
About this study
Official title: Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial
This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial in Chinese patients with intraventricular hemorrhage (IVH), comparing early lumbar drainage added to standard care with standard care alone. The primary objective is to evaluate whether, in patients treated with external ventricular drainage (EVD) and intrathecal urokinase, the addition of early lumbar drainage improves functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications.
Read the detailed description
Intraventricular hemorrhage (IVH) is a life-threatening complication of acute stroke, associated with high rates of mortality and severe disability, fewer than 20% of survivors achieve favorable functional outcomes. Despite the widespread use of external ventricular drainage (EVD) and intraventricular thrombolysis, the role of early lumbar drainage in improving outcomes remains controversial, with limited high-level evidence from randomized controlled trials.
The LD-IVH study will use a 1:1 stratified block randomization design, with stratification by intraparenchymal hematoma and hospital. Eligible patients will be randomized to receive either (1) control group treatment: standard EVD plus daily intrathecal urokinase (30,000 IU) for 3 consecutive days, with a maximum treatment duration of 5 days; or (2) intervention group treatment: the same EVD and intrathecal urokinase regimen as the control group, with early lumbar drainage additionally initiated within 72 hours of onset. CSF was drained at a rate of ≤8 mL/h, with a daily maximum volume of 200 mL, to keep intracranial pressure stable.
The primary endpoint will be the proportion of patients with a favorable functional outcome (modified Rankin Scale [mRS] score 0-3) at 180 days. A total of 392 patients will be enrolled, and an interim efficacy analysis is planned after 50% of participants complete the 180-day follow-up.
- Conditions
- Intraventricular Hemorrhage, Cerebral Hemorrhage
- Being tested
- Control treatment plus lumbar drainage, Control treatment schedule
- Keywords
- Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage, Urokinase, PROBE design, Randomized Controlled Trial
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control treatment plus lumbar drainageProcedure or surgery
Early lumbar cistern drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure.
Control treatment scheduleProcedure or surgery
Patients receive external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase is administered as a single daily dose of 30,000 IU for 3 consecutive days, and the maximum duration of urokinase treatment does not exceed 5 days. Thrombolysis is discontinued when cranial CT demonstrates clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (EVD + Intrathecal Urokinase) | Active comparator | Patients received external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase was administered as a single daily dose of 30,000 IU for 3 consecutive days. A follow-up cranial CT was then performed to assess ventricular obstruction and hematoma clearance, which guided the decision on whether to continue thrombolysis. The maximum total duration of urokinase treatment did not exceed 5 days. Thrombolysis was discontinued when CT demonstrated clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%. Receives: Procedure: Control treatment schedule |
| Intervention Group (Control Treatment + Lumbar Drainage) | Experimental | In addition to the same EVD and intrathecal urokinase regimen as the control group, early lumbar drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure. Receives: Procedure: Control treatment plus lumbar drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with mRS score 0-3 at 180 days after onset
Percentage of patients with modified Rankin Scale score 0 to 3 at 180-day follow-up.
Measured: 180 days after disease onset
Secondary outcomes (13)
Proportion of participants with mRS 0-3 at 90 days after onset
Percentage of patients with a modified Rankin Scale score of 0 to 3 at the 90-day follow-up.
Measured: 90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
Percentage of patients with a Glasgow Outcome Scale (GOS) score of 4 or 5 at the 180-day follow-up.
Measured: 180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
Percentage of patients with a modified Rankin Scale score of 0 to 2 at the 90- and 180-day follow-up.
Measured: 90 and 180 days after disease onset
Change in ordinal mRS score from baseline to 180 days after onset
Change in the ordinal modified Rankin Scale score between baseline and the 180-day follow-up.
Measured: Baseline to 180 days after disease onset
EQ-5D score at 180 days after onset
Health-related quality of life measured by the EuroQol-5D (EQ-5D) questionnaire at the 180-day follow-up.
Measured: 180 days after disease onset
Proportion of participants with Barthel Index score 75-100 at 180 days after onset
Percentage of patients with a Barthel Index score of 75 to 100 at the 180-day follow-up.
Measured: 180 days after disease onset
Proportion of participants with shunt-dependent hydrocephalus before discharge and at 180 days after onset
Percentage of patients requiring permanent cerebrospinal fluid shunting for hydrocephalus before hospital discharge and at the 180-day follow-up.
Measured: Before hospital discharge and 180 days after disease onset
Daily CSF drainage volume before catheter removal
Daily volume of cerebrospinal fluid drained (mL/day) from the external ventricular drain and lumbar drain before removal of the drainage catheters.
Measured: During the drainage period before catheter removal
Proportion of participants with resolution of third and/or fourth ventricular obstruction
Percentage of patients with resolution of third and/or fourth ventricular obstruction on cranial CT within 14 days after enrollment or before hospital discharge.
Measured: Within 14 days after enrollment or before hospital discharge
Dynamic intracranial hemorrhage clearance rate before catheter removal
Serial (dynamic) rate of intracranial hemorrhage clearance on cranial CT before removal of the external ventricular and lumbar drainage catheters.
Measured: Before removal of the external ventricular and lumbar drainage catheters
Length of hospital stay
Total duration of hospitalization (days).
Measured: From admission to hospital discharge
Length of NICU stay
Total duration of stay in the intensive care unit (days).
Measured: From NICU admission to NICU discharge
Total hospitalization costs
Total medical costs incurred during hospitalization, in RMB.
Measured: From admission to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Shigang Lv, MD, Principal investigator, Second Affiliated Hospital of Nanchang UniversityMiaojing Wu, MD, Principal investigator, Second Affiliated Hospital of Nanchang UniversityZeguang Ren, Prof, Principal investigator, Methodist Houston Sugar Land Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625449
- Sponsor's protocol ID
- LD-IVH-2026-001
- Other IDs
- ChiCTR2600123877
- Acronym
- LD-IVH
- Status last verified
- Mar 2026
- First submitted
- 16 May 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07625449
- Acronym / sponsor ID
- LD-IVH / LD-IVH-2026-001
- Conditions
- Intraventricular Hemorrhage, Cerebral Hemorrhage
- Keywords
- Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage, Urokinase, PROBE design, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 4 Jun 2026 (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.
This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial in Chinese patients with intraventricular hemorrhage (IVH), comparing early lumbar drainage added to standard care with standard care alone. The primary objective is to evaluate whether, in patients treated with external ventricular drainage (EVD) and intrathecal urokinase, the addition of early lumbar drainage improves functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications.
Detailed description
Intraventricular hemorrhage (IVH) is a life-threatening complication of acute stroke, associated with high rates of mortality and severe disability, fewer than 20% of survivors achieve favorable functional outcomes. Despite the widespread use of external ventricular drainage (EVD) and intraventricular thrombolysis, the role of early lumbar drainage in improving outcomes remains controversial, with limited high-level evidence from randomized controlled trials.
The LD-IVH study will use a 1:1 stratified block randomization design, with stratification by intraparenchymal hematoma and hospital. Eligible patients will be randomized to receive either (1) control group treatment: standard EVD plus daily intrathecal urokinase (30,000 IU) for 3 consecutive days, with a maximum treatment duration of 5 days; or (2) intervention group treatment: the same EVD and intrathecal urokinase regimen as the control group, with early lumbar drainage additionally initiated within 72 hours of onset. CSF was drained at a rate of ≤8 mL/h, with a daily maximum volume of 200 mL, to keep intracranial pressure stable.
The primary endpoint will be the proportion of patients with a favorable functional outcome (modified Rankin Scale [mRS] score 0-3) at 180 days. A total of 392 patients will be enrolled, and an interim efficacy analysis is planned after 50% of participants complete the 180-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (EVD + Intrathecal Urokinase) | Active comparator | Procedure: Control treatment schedulePatients received external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase was administered as a single daily dose of 30,000 IU for 3 consecutive days. A follow-up cranial CT was then performed to assess ventricular obstruction and hematoma clearance, which guided the decision on whether to continue thrombolysis. The maximum total duration of urokinase treatment did not exceed 5 days. Thrombolysis was discontinued when CT demonstrated clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%. |
| Intervention Group (Control Treatment + Lumbar Drainage) | Experimental | Procedure: Control treatment plus lumbar drainageIn addition to the same EVD and intrathecal urokinase regimen as the control group, early lumbar drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-85 years, of either sex.
- First-ever intracerebral hemorrhage (ICH) with CT-confirmed hemorrhage involving the third and/or fourth ventricle, and scheduled to undergo or already having undergone burr-hole ventricular drainage.
- Intraparenchymal hemorrhage volume <30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization.
- Randomization completed within 72 hours of symptom onset.
- Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities).
Key exclusion criteria (14 listed)
- Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor.
- Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase.
- Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal.
- Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site).
- Infratentorial hemorrhage with a volume ≥10 mL.
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 |
|---|---|---|
| Control treatment plus lumbar drainageEarly lumbar cistern drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure. | Procedure or surgery | Intervention Group (Control Treatment + Lumbar Drainage) |
| Control treatment schedulePatients receive external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase is administered as a single daily dose of 30,000 IU for 3 consecutive days, and the maximum duration of urokinase treatment does not exceed 5 days. Thrombolysis is discontinued when cranial CT demonstrates clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%. | Procedure or surgery | Control Group (EVD + Intrathecal Urokinase) |
Primary outcome
Proportion of participants with mRS score 0-3 at 180 days after onset
Time frame: 180 days after disease onset
Percentage of patients with modified Rankin Scale score 0 to 3 at 180-day follow-up.
13 secondary outcomes
Proportion of participants with mRS 0-3 at 90 days after onset
Time frame: 90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
Time frame: 180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
Time frame: 90 and 180 days after disease onset
Change in ordinal mRS score from baseline to 180 days after onset
Time frame: Baseline to 180 days after disease onset
EQ-5D score at 180 days after onset
Time frame: 180 days after disease onset
Proportion of participants with Barthel Index score 75-100 at 180 days after onset
Time frame: 180 days after disease onset
Proportion of participants with shunt-dependent hydrocephalus before discharge and at 180 days after onset
Time frame: Before hospital discharge and 180 days after disease onset
Daily CSF drainage volume before catheter removal
Time frame: During the drainage period before catheter removal
Proportion of participants with resolution of third and/or fourth ventricular obstruction
Time frame: Within 14 days after enrollment or before hospital discharge
Dynamic intracranial hemorrhage clearance rate before catheter removal
Time frame: Before removal of the external ventricular and lumbar drainage catheters
Length of hospital stay
Time frame: From admission to hospital discharge
Length of NICU stay
Time frame: From NICU admission to NICU discharge
Total hospitalization costs
Time frame: From admission to hospital discharge
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 4 Sep 2026.
- 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.
Shigang Lv, MD principal investigator
Second Affiliated Hospital of Nanchang University
Miaojing Wu, MD principal investigator
Second Affiliated Hospital of Nanchang University
Zeguang Ren, Prof principal investigator
Methodist Houston Sugar Land Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intraventricular Hemorrhage and Cerebral Hemorrhage, run by Second Affiliated Hospital of Nanchang University at 31 sites 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 6 inclusion and 14 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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?
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 Ping Hu, MD (+86 13097286794, hp666edu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with mRS score 0-3 at 180 days after onset (time frame: 180 days after disease onset). 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 4 Sep 2026.