Hypothermia Following Acute Spinal Cord Injury
Completed
Conditions studied: Spinal Cord Injury
In brief
The purpose of this study is to investigate the long term outcome of patients who receive hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia has been used for certain patients with spinal cord injury for the past two years. This study will collect data from vital signs and examinations while the patient is in the hospital and also when they follow up as an outpatient after they are discharged or go to a rehabilitation center. This data will then be analyzed and compared only to historically published data from previous studies. The aim of this investigation is to determine if intravascular hypothermia results in a beneficial outcome for patients with spinal cord injury.
Key facts
- Study ID
- NCT01739010
- Run by
- University of Miami
- People needed
- 41
- Starts
- 2007-01-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2019-01-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 - 65 years of age, ASIA (American Spinal Injury Association) Impairment Scale (AIS) Score A or B, non-penetrating injury, and absence of severe systemic injury or coagulopathy. Patients urgently taken to the OR for reduction may also be included.
You may not qualify if…
- Age > 65 years, ASIA (American Spinal Injury Association) Impairment Scale (AIS) Score C or D, Hyperthermia on admission (> 37 degrees Celsius), Severe systemic injury, Severe bleeding, Pregnancy, Coagulopathy, Thrombocytopenia, Known prior cardiac history, Blood dyscrasia, Pancreatitis, Raynuad's syndrome, Penetrating spinal column injury (gunshot and knife wounds etc.), Cord transection. Patients who are intubated and sedated prior to initial examination by the neurosurgical team and patients showing an improvement in the neurologic exam within 12 hours from the injury will also be excluded.
Where it is running
- Jackson Memorial Hospital — Miami, Florida, United States
Full record on ClinicalTrials.gov
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