Systemic Hypothermia in Acute Cervical Spinal Cord Injury

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.

Inclusion Criteria:

- 18 - 70 years of age

- AIS Grade A - C

- Glasgow Coma Scale ≥14

- Able to start hypothermia treatment within 24 hours of injury

- Non-penetrating injury. Patients urgently taken to the operating room for surgical
reduction may also be included.

Exclusion Criteria:

- Age > 70 years

- AIS Grade D

- Hyperthermia on admission (>38.5ºC)

- Severe systemic injury

- Severe bleeding

- Pregnancy

- Coagulopathy

- Thrombocytopenia

- Known prior severe cardiac history

- Blood dyscrasia

- Pancreatitis

- Reynaud's syndrome

- Cord transection