Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

Completed · Phase 2 · Has a placebo group

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT00827892

Run by

The University of Texas Health Science Center, Houston

People needed

84

Starts

2009-03-01

Expected to finish

2013-11-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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