Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the potential for clinical hypothermia following SCI to improve neurological outcome has significant value. Many patients suffering SCI become permanently dependent on caretakers and become a financial liability to both the family and society. Hypothermia has the potential to improve outcome so that more patients suffering SCI can regain independent motor and sensory function and remain economically productive members of society. The use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute SCI and may also have more widespread uses in patients presenting with stroke or cardiac arrest. In the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02991690
Study type	Interventional
Source	University of Miami
Contact	George Jimsheleishvili, MD
Phone	305-243-4781
Email	gxj150@miami.edu
Status	Recruiting
Phase	N/A
Start date	August 4, 2017
Completion date	September 2025

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See also
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