Basal Ganglia HaematomaSOITBENCT03957707
Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation
A study testing stereotactic surgery plus thrombolysis and Guideline-based standard medical management in people with Basal Ganglia Haematoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Basal Ganglia Haematoma
- What is being tested?
- stereotactic surgery plus thrombolysis and Guideline-based standard medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a hematoma volume of 10-30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
- With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
- Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml by ABC/2 formula).
- Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
- Randomization within 72 hours after diagnostic CT.
- Surgery should be performed within 72 hours after onset.
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- SBP <180 mmHg maintained for 6 hours prior to randomization.
- Age between 18-70 years old.
- mRS score ≤ 1 in past medical history.
- Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment.
Who cannot join
- Hematoma involves other structures such as the thalamus and midbrain.
- Mass effect or hydrocephalus due to intraventricular hemorrhage.
- Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
- Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
- Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.
- Patients with any irreversible coagulopathy or known coagulation disorders; platelet count <100,000; INR > 1.4.
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- Patients requiring long-term use of anticoagulants.
- Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
- Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding mainly occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site.
- May be pregnant in the near future or already pregnant.
- Previously enrolled in this study.
- Participating in other interventional medical research or clinical trials at the same time. Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial.
- Patients with an expected survival of less than 6 months.
- Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.
- Patients with mechanical heart valve. Biological valves are acceptable.
- Patients with risk of embolism (including a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis). Atrial fibrillation without mitral stenosis is acceptable.
- Investigators believe co-morbidities would be detrimental to the patient when the study begins.
- Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.).
- Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
- Patient is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.
Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.
- Conditions
- Basal Ganglia Haematoma
- Being tested
- stereotactic surgery plus thrombolysis, Guideline-based standard medical management
- Keywords
- basal ganglion hemorrhage, stereotactic surgery, thrombolysis
- Medical subject headings
- Basal Ganglia Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic surgery plus thrombolysisProcedure or surgery
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
Guideline-based standard medical managementOther
Guideline-based standard medical management
| Study group | Role | What they receive |
|---|---|---|
| stereotactic surgery with drugs treatment | Experimental | Not described Receives: Procedure: stereotactic surgery plus thrombolysis |
| Guideline-based standard medical management | Sham comparator | Not described Receives: Other: Guideline-based standard medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score
Functional independence is defined as achieving a score of 0, 1, or 2 on the mRS. The mRS is a 7-point scale that measures the degree of disability or dependence in the daily activities of patients who have had a stroke. The scale ranges from 0 (no symptoms) to 6 (dead).
Measured: 180 days
Secondary outcomes (6)
All-Cause Mortality
Time from randomization to death from any cause up to 180 days.
Measured: 180 days
Barthel Index (BI)
Functional status in activities of daily living (ADL) will be assessed using the Barthel Index (BI). The BI score ranges from 0 (completely dependent) to 100 (fully independent).
Measured: 180 days
Glasgow Outcome Scale-Extended (GOS-E) score
The GOS-E is an 8-point scale that categorizes global outcomes from Dead (1) to Upper Good Recovery (8).
Measured: 180 days
Residual Hematoma Volume
Absolute volume (in mL) of the hematoma remaining at 24 hours (± 6 hours) and at 1 month (± 7 days) post-intervention
Measured: 24 hours and one month
Length of Initial Hospital Stay
Total duration (in days) of the index hospitalization from admission to discharge (excluding transfers to other acute care facilities)
Measured: one month
Total direct medical costs during the index hospitalization
Total direct healthcare costs related to the index ICH event incurred during the index hospitalization, assessed from a healthcare system perspective
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jan 2019
- Primary completion1 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Ganglia HaematomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Ningbo No. 1 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Affiliated Wenling Hospital of Wenzhou Medical University, Zhuji People's Hospital of Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Jinhua Central Hospital, Huzhou Central Hospital, People's Hospital of Quzhou, The Second Affiliated Hospital of Jiaxing University, Xiaoshan Hospital, Lishui Country People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957707
- Sponsor's protocol ID
- 2018-222
- Acronym
- SOITBE
- Status last verified
- Sep 2026
- First submitted
- 19 May 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03957707
- Acronym / sponsor ID
- SOITBE / 2018-222
- Conditions
- Basal Ganglia Haematoma
- Keywords
- basal ganglion hemorrhage, stereotactic surgery, thrombolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Ningbo No. 1 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Affiliated Wenling Hospital of Wenzhou Medical University, Zhuji People's Hospital of Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Jinhua Central Hospital, Huzhou Central Hospital, People's Hospital of Quzhou, The Second Affiliated Hospital of Jiaxing University, Xiaoshan Hospital, Lishui Country People's Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 21 May 2019 (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.
Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stereotactic surgery with drugs treatment | Experimental | Procedure: stereotactic surgery plus thrombolysis |
| Guideline-based standard medical management | Sham comparator | Other: Guideline-based standard medical management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a hematoma volume of 10-30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
- With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
- Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml by ABC/2 formula).
- Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
- Randomization within 72 hours after diagnostic CT.
Key exclusion criteria (20 listed)
- Hematoma involves other structures such as the thalamus and midbrain.
- Mass effect or hydrocephalus due to intraventricular hemorrhage.
- Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
- Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
- Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.
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 |
|---|---|---|
| stereotactic surgery plus thrombolysisstereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent | Procedure or surgery | stereotactic surgery with drugs treatment |
| Guideline-based standard medical managementGuideline-based standard medical management | Other | Guideline-based standard medical management |
Primary outcome
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score
Time frame: 180 days
Functional independence is defined as achieving a score of 0, 1, or 2 on the mRS. The mRS is a 7-point scale that measures the degree of disability or dependence in the daily activities of patients who have had a stroke. The scale ranges from 0 (no symptoms) to 6 (dead).
6 secondary outcomes
All-Cause Mortality
Time frame: 180 days
Barthel Index (BI)
Time frame: 180 days
Glasgow Outcome Scale-Extended (GOS-E) score
Time frame: 180 days
Residual Hematoma Volume
Time frame: 24 hours and one month
Length of Initial Hospital Stay
Time frame: one month
Total direct medical costs during the index hospitalization
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic surgery plus thrombolysis and Guideline-based standard medical management in people with Basal Ganglia Haematoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 23 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 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score (time frame: 180 days). 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 23 Sep 2026.