Spontaneous Cerebral HemorrhageNCT06429553
Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage
A study testing Minimally invasive hematoma aspiration drainage combined with urokinase injection in people with Spontaneous Cerebral Hemorrhage, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Cerebral Hemorrhage
- What is being tested?
- Minimally invasive hematoma aspiration drainage combined with urokinase injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years;
- ICH in the basal ganglia was diagnosed by CT examination of the head (bleeding mainly from the caudate nucleus, lentiform nucleus, clavate nucleus or amygdala);
- Based on CT examination of the head, the volume of hematoma was calculated to be 20-40 mL, and the midline structure was shifted horizontally in the pineal gland < 3 mm; The calculation formula of hematoma volume V (cm3) = A*B*C*1/2, where A is the longest diameter (cm) of the largest level of hematoma in the horizontal CT scan, B is the widest diameter (cm) of the hematoma in the plane perpendicular to A, and C is the thickness (cm) of the hematoma in the CT film;
- The time from onset to randomization is within 48 hours;
- GCS score 4-14 points during randomization;
- NIHSS score >= 6 points during randomization;
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- Muscle strength of unilateral limbs on the symptomatic side is grade 0-3;
- mRS0-1 score before onset;
- Systolic blood pressure was controlled below 180mmHg before randomization;
- Written informed consent signed by the patient and his legal representative.
Who cannot join
- Bleeding in other areas (such as the thalamus, brain stem, or cerebellum);
- Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage transformation of massive cerebral infarction, hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, severe coagulation disorder;
- Recent history of cerebral hemorrhage (< 1 year);
- Multiple intracranial hemorrhage;
- The CTA source map indicated early signs of expanded intracerebral hemorrhage hematoma (point sign), and the possibility of progressive hemorrhage was largely ruled out;
- Patients with ventricular hemorrhage or ICH intrusion into the ventricle should be considered for external ventricular drainage;
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- Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history within the last 30 days;
- Patients with coagulation dysfunction such as hereditary or acquired bleeding constitution and lack of coagulation factor;
- Hemoglobin < 100 g/L, hematocrit < 25%, platelet count < 100*10^9/L;
- Were receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within one week before enrollment, with INR > 1.4;
- Long-term anticoagulant and antiplatelet therapy is expected;
- There is a history of internal bleeding, such as digestive tract bleeding, urogenital system bleeding, respiratory tract bleeding is not completely controlled;
- Myocardial infarction within the last 30 days;
- Known high risk of embolism, including patients with mechanical heart valve implantation, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is suitable;
- Severe liver function damage, ALT > 3 times the upper limit of normal, or AST > 3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate < 30 ml/min/1.73m2;
- Hypertension that could not be effectively controlled by active antihypertensive therapy before randomization (systolic blood pressure was still greater than 180 mmHg);
- Patients with Alzheimer's disease or mental illness are unable to complete the follow-up plan as required;
- Combined with any serious diseases that may be assessed to interfere with the test results: including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system and blood system;
- Those who currently have drug or alcohol abuse or dependence and are expected to have poor compliance and difficulty in completing follow-up;
- Allergic to urokinase or surgery-related drugs and instruments;
- Pregnant or lactating women, or those planning to become pregnant within one year;
- Life expectancy of < 12 months due to advanced stage of any disease;
- Are participating in other clinical trials or have been included in this trial in the previous stage;
- The patient or his legal guardian is not willing to sign a written informed consent (YNMT).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hao Xu
Hefei, Anhui, 230001
Hao Xu, PhD, +8618019576586, xuhao2021@ustc.edu.cn
About this study
Official title: A Multicenter Randomized Controlled Clinical Study of Minimally Invasive Intracranial Hematoma Aspiration and Drainage Combined With Urokinase Injection and Drug Therapy for Spontaneous Intracerebral Hemorrhage
To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage.
Read the detailed description
Intracerebral hemorrhage (ICH) refers to the spontaneous rupture of large and small arteries, veins, and capillaries in the brain caused by various reasons under non-traumatic conditions. Hypertension is the most common predisposing factor for intracerebral hematoma, and the risk increases with age. The challenge in surgical hematoma evacuation lies in the potential for surgical complications to negate the benefits of hematoma removal. Surgical treatment is generally considered only when the supratentorial hematoma causes a life-threatening space-occupying effect. Therefore, the size of the intracerebral hematoma is a key factor in determining whether surgery can bring benefits to patients. Specifically, intracerebral hematomas with a volume less than 30 ml are considered small and medium-sized.
Previously, drug-based conservative treatment was often the first choice for small and medium-sized intracerebral hematomas. However, with the accumulation of clinical data, it has been found that while these patients have low blood loss and mortality, their neurological function impairment is significant, and the recovery of neurological function under conservative treatment is often suboptimal. Therefore, some scholars have suggested the use of adjunctive surgical options for small and medium-sized intracerebral hematomas, such as small craniotomy, craniotomy, endoscopic surgery, fibrinolytic therapy combined with hematoma aspiration, and CT-guided stereotactic aspiration (i.e., minimally invasive surgery).
- Conditions
- Spontaneous Cerebral Hemorrhage
- Being tested
- Minimally invasive hematoma aspiration drainage combined with urokinase injection
- Keywords
- Spontaneous cerebral hemorrhage, intracranial hematoma aspiration, urokinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive hematoma aspiration drainage combined with urokinase injectionProcedure or surgery
Minimally invasive hematoma aspiration drainage combined with urokinase injection
| Study group | Role | What they receive |
|---|---|---|
| Hematoma puncture group | Experimental | Minimally invasive hematoma aspiration drainage combined with urokinase injection Receives: Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection |
| Drug conserved group | Sham comparator | Drug conserved group Receives: Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
Measured: 6 months
Secondary outcomes (3)
volume of hematoma
volume of hematoma
Measured: 2 weeks
National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）
National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）
Measured: 6 months
Muscle strength classification change（0-5）（ higher scores mean a better outcome.）
Muscle strength classification change（0-5）（ higher scores mean a better outcome.）
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jul 2023
- Primary completion30 Jun 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 Spontaneous Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429553
- Sponsor's protocol ID
- 2023KY135
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Study of Minimally Invasive Intracranial Hematoma Aspiration and Drainage Combined With Urokinase Injection and Drug Therapy for Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06429553
- Acronym / sponsor ID
- 2023KY135
- Conditions
- Spontaneous Cerebral Hemorrhage
- Keywords
- Spontaneous cerebral hemorrhage, intracranial hematoma aspiration, urokinase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 May 2024 (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.
To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage.
Detailed description
Intracerebral hemorrhage (ICH) refers to the spontaneous rupture of large and small arteries, veins, and capillaries in the brain caused by various reasons under non-traumatic conditions. Hypertension is the most common predisposing factor for intracerebral hematoma, and the risk increases with age. The challenge in surgical hematoma evacuation lies in the potential for surgical complications to negate the benefits of hematoma removal. Surgical treatment is generally considered only when the supratentorial hematoma causes a life-threatening space-occupying effect. Therefore, the size of the intracerebral hematoma is a key factor in determining whether surgery can bring benefits to patients. Specifically, intracerebral hematomas with a volume less than 30 ml are considered small and medium-sized.
Previously, drug-based conservative treatment was often the first choice for small and medium-sized intracerebral hematomas. However, with the accumulation of clinical data, it has been found that while these patients have low blood loss and mortality, their neurological function impairment is significant, and the recovery of neurological function under conservative treatment is often suboptimal. Therefore, some scholars have suggested the use of adjunctive surgical options for small and medium-sized intracerebral hematomas, such as small craniotomy, craniotomy, endoscopic surgery, fibrinolytic therapy combined with hematoma aspiration, and CT-guided stereotactic aspiration (i.e., minimally invasive surgery).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematoma puncture group | Experimental | Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injectionMinimally invasive hematoma aspiration drainage combined with urokinase injection |
| Drug conserved group | Sham comparator | Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injectionDrug conserved group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-80 years;
- ICH in the basal ganglia was diagnosed by CT examination of the head (bleeding mainly from the caudate nucleus, lentiform nucleus, clavate nucleus or amygdala);
- Based on CT examination of the head, the volume of hematoma was calculated to be 20-40 mL, and the midline structure was shifted horizontally in the pineal gland < 3 mm; The calculation formula of hematoma volume V (cm3) = A*B*C*1/2, where A is the longest diameter (cm) of the largest level of hematoma in the horizontal CT scan, B is the widest diameter (cm) of the hematoma in the plane perpendicular to A, and C is the thickness (cm) of the hematoma in the CT film;
- The time from onset to randomization is within 48 hours;
- GCS score 4-14 points during randomization;
Key exclusion criteria (24 listed)
- Bleeding in other areas (such as the thalamus, brain stem, or cerebellum);
- Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage transformation of massive cerebral infarction, hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, severe coagulation disorder;
- Recent history of cerebral hemorrhage (< 1 year);
- Multiple intracranial hemorrhage;
- The CTA source map indicated early signs of expanded intracerebral hemorrhage hematoma (point sign), and the possibility of progressive hemorrhage was largely ruled out;
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 |
|---|---|---|
| Minimally invasive hematoma aspiration drainage combined with urokinase injectionMinimally invasive hematoma aspiration drainage combined with urokinase injection | Procedure or surgery | Drug conserved group, Hematoma puncture group |
Primary outcome
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
Time frame: 6 months
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）
3 secondary outcomes
volume of hematoma
Time frame: 2 weeks
National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）
Time frame: 6 months
Muscle strength classification change（0-5）（ higher scores mean a better outcome.）
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive hematoma aspiration drainage combined with urokinase injection in people with Spontaneous Cerebral Hemorrhage, run by Anhui Provincial 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 10 inclusion and 24 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 28 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.） (time frame: 6 months). 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 28 May 2024.