Hypothermia Clinical Trial
Official title:
Safety and Tolerability of a Protocol of Targeted Temperature Management After Intracerebral Hemorrhage
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.
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). In the second arm, patients will have 72 hours of TTM to Normal
Temperature (NT)(36-37 degrees Celcius). Subjects in all arms will otherwise receive
identical therapeutic interventions pre-defined by our local IPH management protocol.
Primary outcomes are examining the frequency of adverse events (AEs) that will be possibly
or probably related to treatment. AEs will be assessed up to 15-days after admission or
discharge if earlier and the frequency of severe adverse events (SAEs) that will be possibly
and probably related to treatment.
SAEs will be assessed up to 90-days.
The secondary outcome measures will be in-hospital neurological deterioration between day
0-7 (decrease in GCS10 in ≥2 points, or increase in the NIHSS11 ≥4 points), in-hospital
mortality, modified Rankin Score [mRS]12 at discharge and 90-days.
To determine whether TTM to MIH can limit HG and cerebral edema, will be examining absolute
change in hematoma between baseline and 24 hours, new or absolute change in IVH between
baseline and 24 hours, the proportion of patients with HG, absolute change in hemostatic
proteins, the absolute change in cerebral edema between baseline and 24, 48,72, and
168-hours, relative change in cerebral edema.
;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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