SHRINC
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage [SPORTIAS]
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Status:
This study is currently recruiting participants.
Purpose:
To enhance absorption of the blood clot with medication.
This research targets the secondary injury caused by the persistence of toxic blood degradation products in the brain parenchyma. 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.
Interventions:
Pioglitazone
Pioglitazone is in a class of drugs called thiazolidinediones and works by increasing the body's sensitivity to insulin. It is used to treat type 2 diabetes.
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Year Started:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study.
Inclusion Criteria
Clinical presentation of spontaneous ICH; CT scan compatible with spontaneous ICH; time to PIO treatment ≤ 24 hours from symptom onset; GCS ≥ 6 at time of treatment; hematoma volume ≥ 5cc on initial head CT.
Exclusion Criteria
Participation in another investigational trial in the previous 30 days; patient will undergo surgical evacuation of ICH (ventriculostomy does NOT exclude patient); inability to undergo neuroimaging with MRI (e.g. pacer, recent stent, inability to lie flat): ; baseline mRS ≥ 3; primary intraventricular hemorrhage ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma; history of intolerance or allergy to any TZD; thrombocytopenia: platelet count < 100,000; clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs ≥ 2x normal, coagulopathy as described above); co-morbid conditions, which in the opinion of the investigator, are likely to complicate therapy including but not limited to: a history of NYHA class II, III, or IV CHF, clinically significant arrhythmia, end stage AIDS, pregnancy as determined by a urine pregnancy test; severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30%;
malignancy (history of or active); patient unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason.
Patient Involvement:
Study participants will be randomized to one of 2 treatment arms: 1) Pioglitazone in escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI or 2) Placebo capsule administered by mouth daily for the duration of the study as determined by MRI. Study participants will have assessments during hospitalization and at Days 7, 14, 21, 28, 90, and 6 months. Duration of study medication will be determined by the time it takes for 75% of the hematoma to resolve based on MRI.
Primary Outcome:
The primary measure of safety will be mortality at discharge or 2 weeks, whichever comes first.
Secondary Outcome:
Secondary measures of safety will include mortality at 3 months and 6 months, symptomatic cerebral edema during hospitalization, clinically significant congestive heart failure, edema, hypoglycemia, anemia, and hepatotoxicity.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 09/29/2009.
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