The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot lysis with rt-PA。
The minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center with favourable accuracy and safety. The dose of rt-PA range from 0.3 mg to 4.0 mg in different research。We propose to determine the optimal dose of rt-PA with three dose control groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL:93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe. To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale hematoma, gives the filament resolver interrupted for liquefication drainage afterward.
Up to 4 doses of 0.3\~1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
Tongji Hospital
Wuhan, Hubei, China
rate of clot size removal
Time frame: baseline to 24 hours(±12) post the last dose of rt-PA
Mortality
Time frame: 30 days
Procedure related mortality
Time frame: 30 days
Incidence of intracranial infection
Time frame: 30 days
Rate of rebleeding
Time frame: 30 days
Glasgow outcome scale gos
Time frame: 90 days
Glasgow outcome scale gos
Time frame: 180 days
Rankin stroke impact scale
Time frame: 90 days
Rankin stroke impact scale
Time frame: 180 days
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