NCT02472574

Dose-effect Relationship of Rt-PA on ICH Evacuation

Phase 2 Study of Rt-PA Dose-effect Relationship on ICH Evacuation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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。

Detailed description

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.

Conditions

• Hypertensive Intracerebral Hemorrhage

Interventions

Type	Name	Description
DEVICE	YL-1 type of intracranial hematoma puncture needle	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.
DRUG	rt-PA	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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-06-16
• Last updated: 2015-06-16

Locations

1 site across 1 country: China