Hypothermia Following Acute Spinal Cord Injury

NCT01739010 | Completed DMC

• 1 other identifier: 20060556
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• International Standards of Neurological Classification for Spinal Cord Injury

  Change from Baseline at 12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute spinal cord injury patients.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Allan D Levi, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: January 1, 2007
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)