None listed
Conditions
Brief summary
The purpose of this study is to judge the clinical value of minimally invasive stereotactic puncture and thrombolysis therapy (MISPTT) on acute intracerebral hemorrhage(ICH). A randomized control clinical trial was undertaken by means of compare of Glasgow Coma Scale(GCS) score, postoperative complications(PC) and long-term outcome of 1 year postoperation with conventional craniotomy. We expect to verify whether MISPTT could displayed its superiority in minute trauma, safety, and improving long-term outcome.
Interventions
minimally invasive stereotactic puncture and thrombolysis therapy (one intervention group): firstly, the target points was defined according to the computer tomography and mostly target points were chosen in the scan with the largest expansion of the haematoma. Puncture situs was measured and marked on head noticing to get out of the way of main blood vessel, then puncture needle of suitable length(Type YL-1) was fixed on the operative electric drill. The puncture needle was perforated into pred
minimally invasive stereotactic puncture and thrombolysis therapy (one intervention group): firstly, the target points was defined according to the computer tomography and mostly target points were chosen in the scan with the largest expansion of the haematoma. Puncture situs was measured and marked on head noticing to get out of the way of main blood vessel, then puncture needle of suitable length(Type YL-1) was fixed on the operative electric drill. The puncture needle was perforated into predetermined depth, then the probe core removed, hematoma drawn out gently by syringe (diluted by saline solution if blood thicken) until 1/3 of hematoma were removed, then hematoma was continuiosly liquefied by liquefacient(containing 20000U-40000U urokinase/2-3mL saline solution)for 2-4 days(3-5 times per day) until 90% hematoma drained.
Sponsors
zhou houguang
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
(1) diagnosed as having spontaneous hemorrhage in the basal ganglion or brain lobe of the brain by CT scan; (2) hemorrhage volume: 30–100 ml; (3) age range: 40–75 years; (4) muscle strength of the paralyzed limbs: grades 0–3 on the muscle strength scale; (5) hemorrhagic duration (from stroke onset to hospital) within 24 h; (6) informed consent from patients and/or their law representative.
Exclusion criteria
(1) disturbances of blood coagulation, such as thrombocytopenia, hepatitis, etc; (2) traumatic intracranial hemorrhage; (3)intracranial or general infection; (4) complicated with serious heart, liver, renal or lung disease or functional failure; (5) a previous stroke history with neurological deficits; (6) intracranial aneurysm or arteriovenous malformation complicated with hemorrhage; (7) consent form cannot be obtained from the patient herself or her law representative.
Outcome results
None listed