Intracerebral Hemorrhage Clinical Trial
Official title:
Safety and Effectiveness Study of Deferoxamine and Xingnaojing Injection in Intracerebral Hemorrhage
The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.
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 saline placebo, given by continuous IV infusion for 5 consecutive
days. Treatment will be initiated within 12 hours after ICH symptom onset.
The main objectives are:
1. Examining the effects of DFO and Xingnaojing injection on peri-hematoma edema (PHE)
volume progression between baseline and post-treatment CT/MRI scans and the residual
cavity volume at 90 days.
2. Obtaining data on the National Institute of Health Stroke Scale (NIHSS) to explore the
effects of treatment on neurological functions.
3. Examining the effects of DFO and Xingnaojing injection on biomarkers of acute cerebral
hemorrhage such as ferritin, interleukin - 6, matrix metalloproteinase 9, tumor
necrosis factor alpha and so on.
4. Study the traditional Chinese medicine(TCM)curative effect evaluation of the roles of
different treatment methods on secondary damage after ICH.
Secondary and exploratory objectives include:
1. Exploring whether the effect of DFO on outcome is dependent on initial ICH volume,
after adjusting for other prognostic variables, to determine if specific limits for ICH
volume should be specified as exclusion/inclusion criteria for future studies.
2. Exploring the differences between early (≤12h) and late (>12-24h) OTT windows in DFO
treatment effect on functional outcome.
Exploratory study shows that iron chelator deferoxamine is effective and safe in the
treatment of acute cerebral hemorrhage. We choose within 12 hours as the treatment time
window, different from within 24 hours in the current international ongoing HI-DEF test. In
theory, the earlier, the better curative effect. So this experiment is more likely to get a
better curative effect. Xingnaojing injection is widely used in clinical in china, but lack
of rigorous randomized controlled trial to prove its brain protection effect currently.
Successful completion of this study will provide a crucial, reliable experimental evidence
for a new treatment for acute cerebral hemorrhage. ICH is one of main causes of disability
and death. A successful study demonstrating the efficacy of DFO and xingnaojing injection
would be of considerable public health significance.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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