Intracerebral Hemorrhage Clinical Trial
Official title:
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being independent at 6 months. There is currently no approved treatment for ICH which has been shown to improve outcomes. In an effort to develop a new treatment for ICH, this research focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing absorption of the blood clot with medication.
Intracerebral hemorrhage (ICH) remains a devastating disease and current treatment options
lag far behind those for ischemic stroke. Current treatment efforts for ICH are targeted
towards the primary brain injury caused by the hemorrhage and growth of the hematoma. This
research targets the secondary injury caused by the persistence of toxic blood degradation
products in the brain parenchyma.
Based on preclinical work in our lab, the peroxisome proliferator activated receptor-gamma
(PPARγ), a member of the nuclear receptor superfamily, represents a possible target for the
treatment of ICH aimed at promoting hematoma absorption, limiting the pro-inflammatory
response, and protecting salvageable tissue from the damage produced by the persistence of
toxic blood degradation products.
Our primary specific aim is to assess the safety of the PPARγ agonist, pioglitazone (PIO) in
increasing doses for 3 days, when administered to patients with ICH within 24 hrs of symptom
onset. Secondarily, we aim to determine the duration of treatment of PIO for hematoma/edema
resolution in ICH. Lastly, we aim to determine whether speed of hematoma/edema resolution in
ICH represents a radiographic biological marker of activity which can be correlated with
clinical outcome and treatment effect of PIO. The ultimate purpose is to provide baseline
data on an aspect of ICH which has not been previously targeted for treatment in an effort
to develop a safe and effective treatment strategy that may be practical and applicable for
both specialized stroke centers and community hospitals.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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