Status:
COMPLETED
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- age 18-80 years
- clinical presentation of spontaneous ICH
- CT scan compatible with spontaneous ICH
- Time to PIO treatment ≤ 24 hours from symptom onset
- GCS ≥ 6 on initial presentation OR improvement to a GCS ≥ 6 within the time frame for enrollment
- Hematoma volume ≥ 5cc on initial head CT.
Exclusion
- 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)
- a. If patient has mild claustrophobia or agitation amenable to mild sedation (1-2mg lorazepam IV or 5-10mg diazepam PO), he or she may be considered for enrollment. If, however, the patient has severe claustrophobia or agitation, he or she should not be considered for enrollment.
- GCS \< 6
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00827892
Start Date
March 1 2009
End Date
November 1 2013
Last Update
October 2 2015
Active Locations (1)
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1
Memorial Hermann Hospital
Houston, Texas, United States, 77030