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Spinal Cord InjuryNCT01739010

Hypothermia Following Acute Spinal Cord Injury

An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
How many people
41 participants
Where
1 siteUnited States
Study dates
Jan 2007to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute spinal cord injury patients.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jackson Memorial Hospital

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Read the 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.

Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Standards of Neurological Classification for Spinal Cord Injury

    Measured: Change from Baseline at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739010
Sponsor's protocol ID
20060556
Status last verified
Jan 2019
First submitted
28 Nov 2012
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Standards of Neurological Classification for Spinal Cord Injury (time frame: Change from Baseline at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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