Phase
Condition
Brain Injury
Hemorrhage
Stroke
Treatment
Minimally invasive hematoma aspiration drainage combined with urokinase injection
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18-80 years;
ICH in the basal ganglia was diagnosed by CT examination of the head (bleedingmainly 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 < 3mm; The calculation formula of hematoma volume V (cm3) = ABC*1/2, where A is thelongest diameter (cm) of the largest level of hematoma in the horizontal CT scan, Bis the widest diameter (cm) of the hematoma in the plane perpendicular to A, and Cis 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;
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.
Exclusion
Exclusion Criteria:
Bleeding in other areas (such as the thalamus, brain stem, or cerebellum);
Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, braintrauma, brain tumor, hemorrhage transformation of massive cerebral infarction,hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) orcombined 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 hemorrhagehematoma (point sign), and the possibility of progressive hemorrhage was largelyruled out;
Patients with ventricular hemorrhage or ICH intrusion into the ventricle should beconsidered for external ventricular drainage;
Any history of parenchyma or other intracranial subarachnoid, subdural or epiduralblood and surgical history within the last 30 days;
Patients with coagulation dysfunction such as hereditary or acquired bleedingconstitution 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 rivaroxabanwithin 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 valveimplantation, history of left heart thrombosis, mitral stenosis with atrialfibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrialfibrillation without mitral stenosis is suitable;
Severe liver function damage, ALT > 3 times the upper limit of normal, or AST > 3times the upper limit of normal. Severe renal insufficiency, glomerular filtrationrate < 30 ml/min/1.73m2;
Hypertension that could not be effectively controlled by active antihypertensivetherapy before randomization (systolic blood pressure was still greater than 180mmHg);
Patients with Alzheimer's disease or mental illness are unable to complete thefollow-up plan as required;
Combined with any serious diseases that may be assessed to interfere with the testresults: including diseases of the respiratory system, circulatory system, digestivesystem, genitourinary system, endocrine system, immune system and blood system;
Those who currently have drug or alcohol abuse or dependence and are expected tohave 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 inthe previous stage;
The patient or his legal guardian is not willing to sign a written informed consent (YNMT).
Study Design
Study Description
Connect with a study center
Hao Xu
Hefei, Anhui 230001
ChinaActive - Recruiting
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