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| Name | Class |
|---|---|
| Sir Run Run Shaw Hospital | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Second Affiliated Hospital of Wenzhou Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stereotactic surgery with drugs treatment | Experimental |
| |
| drugs treatment alone | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic surgery plus thrombolysis | Procedure | stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | 6 months | |
| Change in 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). |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
Patients is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D020145 | Basal Ganglia Hemorrhage |
| ID | Term |
|---|---|
| D020144 | Basal Ganglia Cerebrovascular Disease |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005343 | Fibrinolytic Agents |
| ID | Term |
|---|---|
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| OTHER |
| Affiliated Wenling Hospital of Wenzhou Medical University | OTHER |
| Zhuji People's Hospital of Zhejiang Province | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| Jinhua Central Hospital | OTHER |
| Huzhou Central Hospital | OTHER |
| People's Hospital of Quzhou | OTHER |
| The Sixth Affiliated Hospital of Wenzhou Medical University | OTHER |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
| Xiaoshan Hospital | UNKNOWN |
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| 6 months |
| Changes in 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). | 6 months |
| Hematoma clearance rate | 1 day and one month |
| Total duration of the initial hospital stays | one month |
| Total direct medical costs during the index hospitalization | one month |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D006401 | Hematologic Agents |