Human Urinary Kallidinogenase Improve Short Term Motor Functional Outcome of Acute Ischemia Stroke Patients
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A total of 80 AIS patients with the unilateral corticospinal tract damage who were matched
      for inclusion criterion were enrolled in this randomized controlled trial. The HUK group was
      administered with HUK and standard treatment(general treatment for anti-platelet,
      lipid-lowering and improving circulation,etc.), the control group received only standard
      treatment. Kallikrein+Standard Treatment Group (general Treatment for anti-platelet,
      lipid-lowering and improving circulation,etc.) and Standard Treatment Group were randomly
      selected.

      At admission and discharge, National Institute of Health Stroke Scale(NIHSS), Barthel
      Index(BI), muscle strength were scored; The DTI were performed and DTT were utilized to
      reconstruct corticospinal tract to observe its direction and appearance changes then to
      evaluate the integrity and impairment degree of the corticospinal tract which was divided
      into four grades according to DTT presented compression, deformation, or rupture. Fractional
      anisotropy(FA) and apparent diffusion coefficient(ADC) of infarct region and corresponding
      contralateral normal regions were measured.

      Blood samples were collected to test serum myelin basic protein(MBP) and vascular endothelial
      growth factor (VEGF) by enzyme-linked immunosorbent assay (ELISA). The primary endpoint is
      the short-term motor function prognosis of the AIS patients, we also evaluated the recovery
      of corticospinal tract and the serum MBP and VEGF changes during treatment in two groups.
    

Intervention name(s): Kallikrein
Intervention type(s): Drug
Intervention description(s): HUK has been approved by China's State Food and Drug Administration as a state category I new drug for the treatment of stroke patients. Based on the available evidence, HUK injection ameliorates neurological deficits and improves long-term outcomes.
Other intervention name(s): Human urinary kallidinogenase
Intervention MeSH terms: Kallikreins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment