Basal Ganglia Haematoma
Conditions
Keywords
basal ganglion hemorrhage, stereotactic surgery, thrombolysis
Brief 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 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.
Interventions
PROCEDUREstereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
OTHERGuideline-based standard medical management
Guideline-based standard medical management
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points. 3. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase \< 5 ml by ABC/2 formula). 4. Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded. 5. Randomization within 72 hours after diagnostic CT. 6. Surgery should be performed within 72 hours after onset. 7. SBP \<180 mmHg maintained for 6 hours prior to randomization. 8. Age between 18-70 years old. 9. mRS score ≤ 1 in past medical history. 10. Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment.
Exclusion criteria
1. Hematoma involves other structures such as the thalamus and midbrain. 2. Mass effect or hydrocephalus due to intraventricular hemorrhage. 3. 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. 4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm. 5. Patients with unsteady hematoma or with progression to intracranial hypertension syndrome. 6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count \<100,000; INR \> 1.4. 7. Patients requiring long-term use of anticoagulants. 8. Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise. 9. 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. 10. May be pregnant in the near future or already pregnant. 11. Previously enrolled in this study. 12. 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. 13. Patients with an expected survival of less than 6 months. 14. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment. 15. Patients with mechanical heart valve. Biological valves are acceptable. 16. 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. 17. Investigators believe co-morbidities would be detrimental to the patient when the study begins. 18. Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.). 19. Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent. 20. Patient is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 180 days | — |
| Barthel Index (BI) | 180 days | 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). |
| Glasgow Outcome Scale-Extended (GOS-E) score | 180 days | The GOS-E is an 8-point scale that categorizes global outcomes from Dead (1) to Upper Good Recovery (8). |
| Residual Hematoma Volume | 24 hours and one month | Absolute volume (in mL) of the hematoma remaining at 24 hours (± 6 hours) and at 1 month (± 7 days) post-randomization |
| Length of Initial Hospital Stay | one month | Total duration (in days) of the index hospitalization from admission to discharge (excluding transfers to other acute care facilities) |
| Total direct medical costs during the index hospitalization | one month | Total direct healthcare costs related to the index ICH event incurred during the index hospitalization, assessed from a healthcare system perspective |
Countries
China
Outcome results
None listed