Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Conditions:Hospital, Hospital, Hospital
Therapuetic Areas:Other
Age Range:18 - 70
Start Date:August 4, 2017
End Date:March 2020
Contact:George Jimsheleishvili, MD

Use our guide to learn which trials are right for you!

Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study

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).

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
We found this trial at
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Richard Rodgers, MD
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
Indianapolis, IN
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
Atlanta, GA
Click here to add this to my saved trials
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Phone: 305-243-4781
Miami, FL
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Philadelphia, PA
Click here to add this to my saved trials