Targeted Temperature Management After Intracerebral Hemorrhage
Status unconfirmed · Phase 2
Conditions studied: Cerebral Hemorrhage, Hypothermia
In brief
Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage (IPH) is common and associated with neurological deterioration and poor clinical outcome. Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with reduction or improvement of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. In this sense, we believe that the initiation of an ultra-early protocol of active temperature modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH, 32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral edema after IPH by modulation of systemic and local inflammatory responses, so we hypothesize that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and cerebral edema after IPH.
Key facts
- Study ID
- NCT01866384
- Run by
- Thomas Jefferson University
- People needed
- 100
- Starts
- 2012-09-01
- Last updated by the study team
- 2014-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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