120 Participants Needed

Hypothermia for Spinal Cord Injury

Recruiting at 4 trial locations
GJ
FA
Overseen ByFaiz Ahmad, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Modest Intravascular Hypothermia, Therapeutic Hypothermia, Protective Hypothermia, Targeted Temperature Management for spinal cord injury?

Research shows that using hypothermia (cooling the body) can help protect the spinal cord after an injury. Studies in both animals and humans have found that cooling can reduce damage and improve recovery, suggesting it might be a helpful treatment for spinal cord injuries.12345

Is hypothermia treatment generally safe for humans?

Hypothermia treatment, used for conditions like spinal cord injury, is generally considered safe in humans, with most complications being related to breathing issues. No patients experienced worsening of their neurological condition due to the treatment.23467

How is the treatment Modest Intravascular Hypothermia different from other treatments for spinal cord injury?

Modest Intravascular Hypothermia is unique because it involves cooling the body to a mild temperature (33 degrees C) using a cooling catheter, which helps protect the spinal cord after injury. This approach is different from other treatments as it focuses on temperature management to improve recovery and has shown promise in both animal models and human patients.238910

What is the purpose of this trial?

This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).

Research Team

AD

Allan Levi, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals aged 18-70 who have suffered a non-penetrating acute cervical spinal cord injury (from the neck to upper back) and can start treatment within 24 hours. They should be mostly conscious (Glasgow Coma Scale ≥14) with specific injury severities (AIS Grade A - C). Excluded are those over 70, less severe injuries (AIS Grade D), high fever, serious other injuries or conditions like heart issues, bleeding disorders, pregnancy, or certain blood diseases.

Inclusion Criteria

I have an injury that didn't break my skin and may need urgent surgery.
My spinal cord injury is classified between Grade A and C.
Glasgow Coma Scale ≥14
See 1 more

Exclusion Criteria

Hyperthermia on admission (>38.5ºC)
Severe systemic injury
I am over 70 years old.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intravascular hypothermia initiated within 24 hours post-injury and maintained at 33 degrees Celsius for 48 hours

2 days

Follow-up

Participants are monitored for neurological and functional improvements

12 months

Treatment Details

Interventions

  • Modest Intravascular Hypothermia
Trial Overview The study tests the safety and effectiveness of cooling the body's core temperature to modest levels (33ºC) using intravascular methods in patients with acute cervical spinal cord injuries. It aims to see if this hypothermia treatment improves outcomes after such an injury.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HypothermiaExperimental Treatment1 Intervention
Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
Group II: ControlActive Control1 Intervention
Standard of care medical treatment, specific to each individual.

Modest Intravascular Hypothermia is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Therapeutic Hypothermia for:
  • Cardiac Arrest
  • Neonatal Encephalopathy
  • Stroke
🇺🇸
Approved in United States as Therapeutic Hypothermia for:
  • Cardiac Arrest
  • Neonatal Encephalopathy
  • Stroke
  • Spinal Cord Injury
🇨🇦
Approved in Canada as Therapeutic Hypothermia for:
  • Cardiac Arrest
  • Neonatal Encephalopathy
  • Stroke
🇯🇵
Approved in Japan as Therapeutic Hypothermia for:
  • Cardiac Arrest
  • Neonatal Encephalopathy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Findings from Research

In a study using a rat model of spinal cord injury, transient systemic hypothermia applied shortly after injury significantly preserved white and gray matter volumes, with increases of 31% and 38% respectively, and four-fold preservation of neurons near the injury site.
Hypothermia also led to improved functional recovery, as indicated by faster improvements in locomotor ability and increased forelimb strength, demonstrating its potential as an effective treatment to reduce damage and neurological deficits after spinal cord injuries.
Systemic hypothermia improves histological and functional outcome after cervical spinal cord contusion in rats.Lo, TP., Cho, KS., Garg, MS., et al.[2009]
In a study of 35 acute cervical spinal cord injury patients treated with intravascular hypothermia at 33°C for 48 hours, 43% showed improvement in neurological function after an average follow-up of 10 months, indicating potential efficacy of this treatment.
The study reported a 14.2% risk of thromboembolic complications, suggesting that while intravascular hypothermia is generally safe, careful monitoring for complications is necessary.
Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study.Dididze, M., Green, BA., Dietrich, WD., et al.[2014]
This study involved 14 patients with acute, complete cervical spinal cord injuries, demonstrating that intravascular cooling can effectively achieve and maintain modest systemic hypothermia (33 degrees C) with minimal variation in body temperature.
The results indicate that while there were some respiratory adverse events, the method of cooling was successful and provides a foundation for future larger studies to evaluate the efficacy of hypothermia in spinal cord injury treatment.
Clinical application of modest hypothermia after spinal cord injury.Levi, AD., Green, BA., Wang, MY., et al.[2009]

References

Systemic hypothermia improves histological and functional outcome after cervical spinal cord contusion in rats. [2009]
Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. [2014]
Clinical application of modest hypothermia after spinal cord injury. [2009]
Technique of selective spinal cord cooling in rat: methodology and application. [2019]
The role of therapeutic hypothermia in the management of acute spinal cord injury. [2022]
The effects of local and general hypothermia on temperature profiles of the central nervous system following spinal cord injury in rats. [2021]
Hypothermia Therapy for Traumatic Spinal Cord Injury: An Updated Review. [2022]
Therapeutic hypothermia for spinal cord injury. [2009]
Systematic review and meta-analysis of therapeutic hypothermia in animal models of spinal cord injury. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of epidural hypothermic saline infusion on locomotor outcome and tissue preservation after moderate thoracic spinal cord contusion in rats. [2015]
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