Clinical Trial: Deferoxamine and Xingnaojing Injection Treatment in Intracerebral Hemorrhage

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Safety and Effectiveness Study of Deferoxamine and Xingnaojing Injection in Intracerebral Hemorrhage

Brief Summary: The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.

Detailed Summary:

Research shows that more than 1/3 of patients with acute cerebral hemorrhage in the first 24 hours will be expanding hematoma. The treatment of acute cerebral hemorrhage has two main targets: prevention of hematoma enlargement in primary brain damage; Reduce hematoma secondary brain damage caused by blood toxicity degradation products. At present, the curative effect of drug treatment of acute cerebral hemorrhage remains limited, using drug therapy to treat hematoma caused by blood toxicity degradation products secondary brain damage, is one of the main current international research direction and hotspot. Recent studies have found that iron overload in cells in acute cerebral hemorrhage stove weeks edema secondary lesion plays a very important role. Acute cerebral hemorrhage animal model research and small sample clinical study has shown that the iron chelator deferoxamine has good curative effect and security. Currently ongoing international HI-DEF test plans to assess the efficacy and safety of high-dose deferoxamine treatment within 24 h of patients with acute cerebral hemorrhage.

Basic research shows Xingnaojing injection can inhibit inflammatory reaction, scavenging free radicals, relieve acute cerebral hemorrhage hematoma surrounding edema and has a variety of brain protection mechanism. The current study builds on these results to assess the potential utility of deferoxamine and Xingnaojing injection as a therapeutic intervention in ICH.

This is a prospective, multi-center, double-blind, randomized, placebo-armed clinical study to test the safety and effectiveness of deferoxamine and Xingnaojing injection treatment in intracerebral hemorrhage. The investigators will randomize 180 subjects with ICH equally (1:1:1) to either DFO at 40mg/kg/day (up to a maximum daily dose of 6000 mg/day), or Xingnaojing injection, or
Sponsor: Capital Medical University

Current Primary Outcome: Numbers of patients with the perihematomal edema (PHE) volume variation. [ Time Frame: 7 days ]

decreases of more than 20% from initial PHE volumes were defined as "decreased" PHE volume; increases of more than 20% from initial PHE volumes were defined as "increased" PHE volume; changes between -20% and 20% were defined as "unchanged".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The residual cavity volume [ Time Frame: 90 days ]
    the variation of residual cavity volume of
  • The variation of the mRS score and the Bathel Index [ Time Frame: 90 days ]
    the variation of mRS score and Bathel Index of different treated subjects from ICH onset to treatment time windows.
  • mortality [ Time Frame: 90 days ]
    the mortality of different treated subjects from ICH onset to treatment time windows.
  • Frequency of Treatment-related Adverse Events [ Time Frame: 90 days ]
    The safety endpoints will include all DFO-related adverse events until day-7 or discharge (whichever is earlier), and DFO-related SAEs and through day-90.


Original Secondary Outcome: Same as current

Information By: Capital Medical University

Dates:
Date Received: February 13, 2015
Date Started: March 2015
Date Completion: December 2016
Last Updated: May 14, 2015
Last Verified: May 2015