Systemic Hypothermia in Acute Cervical Spinal Cord Injury
Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
University of Miami
120 participants
Aug 4, 2017
INTERVENTIONAL
Conditions
Summary
This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).
Eligibility
Plain Language Summary
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Interventions
To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification \[510(k), K030421\]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.
Locations(7)
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NCT02991690