Status:
UNKNOWN
Targeted Temperature Management After Intracerebral Hemorrhage
Lead Sponsor:
Thomas Jefferson University
Conditions:
Cerebral Hemorrhage
Hypothermia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage (IPH) is common and associated with neurological deterioration and poor clinical outcome. Temperature modulatio...
Detailed Description
In this randomized clinical trial, patients with IPH within 6 hours of onset will be randomized to one of two study arms. In one arm, patients will have 72 hours of TTM to MIH (32-34 degree Celcius). ...
Eligibility Criteria
Inclusion
- spontaneous supratentorial IPH documented by CT scan within 6 hours after the onset of symptoms and admission to the Neuro-ICU,
- baseline hematoma \>15cc with or without IVH
- need for mechanical ventilation
Exclusion
- GCS \<6
- age \<18 years
- pregnancy
- pre-morbid mRS\>2
- Do Not Resuscitate (DNR) order "prior" to enrollment
- uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \[UGIB/LGIB\]
- planned surgical decompression within 24 hours
- secondary causes of IPH (ischemic stroke, coagulopathy \[INR\>1.4, aPTT\> 1.5 times baseline, thrombocytopenia platelets \<100,000/uL\], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)
- evidence of sepsis
- inability to obtain written informed consent
- participation in another trial
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01866384
Start Date
September 1 2012
Last Update
December 18 2014
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107