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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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