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Hypothermia Following Acute Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Allan D. Levi, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT01739010
First received: November 28, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy of Intravenously Instituted Hypothermia Treatment in Improving Functional Outcomes in Patients Following Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • International Standards of Neurological Classification for Spinal Cord Injury [ Time Frame: Change from Baseline at 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

It is standard practice at this institution for patients with complete acute spinal cord injury to receive hypothermia. Incomplete injuries may also be treated with hypothermia. This will be a prospective analysis of the data collected at our institution from patients with acute spinal cord injury receiving the hypothermia protocol. The care of these patients will not be affected by this research. Data for normothermia (37 degrees Celsius) will be obtained from historical studies analyzing similar patient groups. Patients arriving to this emergency department have a baseline neurological examination in a timely fashion prior to the induction of hypothermia by a neurosurgical attending or resident. All patients have Magnetic Resonance Imaging (MRI) of the injured spinal cord on admission. Patients that are intubated and medically sedated prior to the initial exam by the neurosurgical team are excluded because the exam at that time may be inaccurate. Patients receiving hypothermia are transferred to the Neurosurgical ICU, intubated and sedated using muscle relaxants. Additional forms of sedation including benzodiazepines or dexmedetomidine are routinely used as an adjunct to curtail a shivering response. For all patients receiving hypothermia, an Alsius CoolGard® Icy Catheter is placed into the IVC via the femoral vein and the temperature cooled to target (33 degrees) at the maximum rate (0.5 degrees/hr). Mean arterial pressure (MAP) is kept >90 mm Hg at all times with fluid boluses (Normal Saline or Albumin 5%) or blood transfusions to keep the hematocrit at 30. Hypothermia at 33 degrees is maintained for 48 hours. Blood cultures are performed daily (from both a peripheral site and from the catheter itself) and an Orogastric tube (OGT) or Nasogastric tube (NGT) is placed in each patient. Nutrition is provided as per our current nutritional supplementation protocol. Intravenous fluids consist of Normal Saline at all times unless the serum Na rises above 160. Serum electrolytes, coagulation studies and complete blood count are performed daily. After 48 hours of hypothermia, the patient is rewarmed to 37 degrees at a controlled rate of 0.1 degree/hr. After reaching 37 degrees, the intravenous catheter is maintained for no more than 6 days total to keep the systemic temperature at 37 degrees. Surface cooling techniques are occasionally utilized for the purpose of maintaining normothermia after 6 days. The patients are discharged to rehabilitation after they are stabilized. All patients will be reevaluated at 6 weeks, 6, and 12 months using the ASIA sensory and motor scales with Functional Independence Measures (FIM). A follow-up MRI scan will be done at one year.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute spinal cord injury patients.

Criteria

Inclusion Criteria:

  • 18 - 65 years of age, AIS Injury 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.

Exclusion Criteria:

  • Age > 65 years, AIS Injury 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739010

Locations
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Allan D Levi, MD, PhD    305-243-2088      
Principal Investigator: Allan D Levi, MD, PhD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Allan D Levi, MD, PhD University of Miami
  More Information

No publications provided

Responsible Party: Allan D. Levi, MD, PhD, Professor of Neurosurgery, University of Miami
ClinicalTrials.gov Identifier: NCT01739010     History of Changes
Other Study ID Numbers: 20060556
Study First Received: November 28, 2012
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Hypothermia
Spinal Cord Injuries
Body Temperature Changes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014