Actively Recruiting
DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
Led by Zhongming Qiu · Updated on 2023-09-13
100
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
Z
Zhongming Qiu
Lead Sponsor
X
Xingguo County People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain. The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
CONDITIONS
Official Title
DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Diagnosed intracerebral hemorrhage in the basal ganglia by CT
- Bleeding volume between 20 and 40 ml with less than 3 mm midline shift at the pineal gland
- Corticospinal tract integrity graded 2 to 4 on diffusion tensor imaging
- Randomization within 24 hours of symptom onset
- Glasgow Coma Scale score of 4 or higher at randomization
- Muscle strength level 3 or higher in the affected limb
- Written informed consent provided by patient or legal representative
You will not qualify if you...
- Bleeding in other brain areas such as thalamus, brainstem, or cerebellum
- Bleeding caused by aneurysm, arteriovenous malformation, brain trauma, brain tumor, large cerebral infarction, beta amyloidosis, or coagulation disorders
- Multiple intracranial hemorrhages
- Ventricular hemorrhage or hemorrhage ruptured into ventricles requiring ventricular drainage
- History of brain or intracranial hemorrhage or surgery within the past 30 days
- Myocardial infarction within the past 30 days
- Uncontrolled bleeding history such as gastrointestinal, genitourinary, or respiratory bleeding
- Low hemoglobin (<100 g/L), hematocrit (<25%), or platelet count (<100 x 10^9/L)
- Use of anticoagulants like warfarin, dabigatran, or rivaroxaban within one week before enrollment with INR >1.4
- Expected need for long-term anticoagulation or antiplatelet therapy
- Allergy to altepase, urokinase, or surgery-related drugs or devices
- Pregnant or breastfeeding women
- High risk of embolism due to mechanical heart valves, left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis
- Uncontrolled hypertension with systolic blood pressure over 180 mmHg despite treatment
- Life expectancy less than 12 months due to advanced disease
- Participation in other interventional clinical trials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xingguo County People's Hospital
Ganzhou, Jiangxi, China
Actively Recruiting
Research Team
Z
Zhongming Qiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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