Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

1. age 18-80 years

2. clinical presentation of spontaneous ICH

3. CT scan compatible with spontaneous ICH

4. Time to PIO treatment ≤ 24 hours from symptom onset

5. GCS ≥ 6 on initial presentation OR improvement to a GCS ≥ 6 within the time frame for enrollment

6. Hematoma volume ≥ 5cc on initial head CT.

Exclusion Criteria:

1. Participation in another investigational trial in the previous 30 days

2. Patient will undergo surgical evacuation of ICH (ventriculostomy does NOT exclude patient)

3. 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.

4. GCS < 6

5. Baseline mRS ≥ 3

6. Primary intraventricular hemorrhage

7. ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma

8. History of intolerance or allergy to any TZD

9. Thrombocytopenia: platelet count < 100,000

10. Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs ≥ 2x normal, coagulopathy as described above)

11. Co-morbid conditions, which in the opinion of the investigator, are likely to complicate therapy including but not limited to:

1. A history of NYHA class II, III, or IV CHF

2. clinically significant arrhythmia

3. end stage AIDS

12. Pregnancy as determined by a urine pregnancy test

13. Severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30%

14. Malignancy (history of or active)

15. Patient unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason