Dose-effect Relationship of Rt-PA on ICH Evacuation

Hypertensive Intracerebral Hemorrhage Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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。

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertensive Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive

• NCT number: NCT02472574
• Study type: Interventional
• Source: Tongji Hospital
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2015
• Completion date: June 2018