drugset / Trial / NCT04102956

Human Urinary Kallidinogenase Improve Short Term Motor Functional Outcome of Acute Ischemia Stroke Patients

NCT04102956

Phase 4 Completed 80 enrolled The Second Hospital of Hebei Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Acute cerebral infarction is a common type of ischemic stroke, causing brain dysfunction in patients with high morbidity and disability. With the changes in people's diet, lifestyle patterns and population aging, the incidence of acute cerebral infarction has increased year by year, which has become an important cause of disability and death in middle-aged and elderly patients. The human urinary kallidinogenase (HUK) was used in China in the management of acute ischemic stroke (AIS) in recent years. However, the mechanism of HUK on AIS has not been systematically investigated. This study aimed to assess the effect of HUK on motor functional outcome and relative corticospinal tract recovery in the patients with AIS. Diffusion tensor imaging(DTI) and diffusion tensor tractography(DTT) have all been used to observe features of cerebral white matter fibrous structures. In addition, diffusion tensor tractography which is used to trace fiber bundle and evaluate white matter fiber bundle integrity and direction is the only non-invasive imaging method to display the corticospinal tract in vivo.

Timeline

Start
2017-07-01
Primary completion
2019-03-01
Completion
2019-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Human Urinary Kallidinogenase Protein / enzyme biologic 0.15 unknown Intravenous

Indications