- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01739010
Hypothermia Following Acute Spinal Cord Injury
January 7, 2019 updated by: Allan D. Levi, MD, PhD, University of Miami
Efficacy of Intravenously Instituted Hypothermia Treatment in Improving Functional Outcomes in Patients Following Acute Spinal Cord Injury
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.
Study Overview
Status
Completed
Conditions
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 Inferior Vena Cava (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 American Spinal Injury Association (ASIA) sensory and motor scales with Functional Independence Measures (FIM).
A follow-up MRI scan will be done at one year.
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Jackson Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acute spinal cord injury patients.
Description
Inclusion Criteria:
- 18 - 65 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International Standards of Neurological Classification for Spinal Cord Injury
Time Frame: Change from Baseline at 12 months
|
Change from Baseline at 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allan D Levi, MD, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2007
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
November 28, 2012
First Submitted That Met QC Criteria
November 28, 2012
First Posted (Estimate)
November 30, 2012
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20060556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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