Hypothermia for Spinal Cord Injury

Recruiting at 4 trial locations

Overseen By Faiz Ahmad, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Age > 70, Pregnancy, Severe cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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. ^{2 3 8 9 10}

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

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

Exclusion Criteria

Hyperthermia on admission (>38.5ºC)

Severe systemic injury

I am over 70 years old.

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

Group I: Hypothermia Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of modest hypothermia after spinal cord injury. Levi, AD., Green, BA., Wang, MY., et al.[2009]

A new technique using subcutaneous perfusion cooling in rats effectively lowers spinal cord temperature (SCT) to 27 degrees C within 15 minutes without affecting overall body temperature, allowing for targeted spinal cord hypothermia.

This selective spinal cord hypothermia can be maintained for up to 5 hours and offers complete protection against spinal cord injury during periods of normothermic ischemia, demonstrating its potential for therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of selective spinal cord cooling in rat: methodology and application. Marsala, M., Galik, J., Ishikawa, T., et al.[2019]

Local hypothermia showed promise in improving recovery after spinal cord injury (SCI) in early animal studies, but clinical trials in the 1970s did not support these findings, leading to decreased interest.

Systemic hypothermia has been successfully used in both animals and humans since the 1980s, with preliminary data indicating that modest systemic hypothermia applied for 48 hours may provide the best therapeutic value, highlighting the need for further large-scale clinical trials to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of therapeutic hypothermia in the management of acute spinal cord injury. Martirosyan, NL., Patel, AA., Carotenuto, A., et al.[2022]

In a study involving rats with spinal cord injuries, general hypothermia (32°C) resulted in greater temperature drops in both the spinal cord and cortex compared to local hypothermia (30°C), indicating that general hypothermia affects healthy tissues more significantly.

Local hypothermia may be a better option for prolonged treatment of spinal cord injuries, as it minimizes temperature changes in healthy areas like the cortex while still providing neuroprotective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of local and general hypothermia on temperature profiles of the central nervous system following spinal cord injury in rats. Bazley, FA., Pashai, N., Kerr, CL., et al.[2021]

Preclinical studies indicate that both systemic and local hypothermia significantly improve neurological recovery following traumatic spinal cord injury (TSCI), suggesting a potential therapeutic benefit.

In clinical trials involving 60 patients, hypothermia treatment was found to be safe, with no cases of neurological deterioration, but its efficacy in promoting neurological recovery remains inconclusive, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothermia Therapy for Traumatic Spinal Cord Injury: An Updated Review. Ransom, SC., Brown, NJ., Pennington, ZA., et al.[2022]

Modest hypothermia (33 degrees C) has been shown to improve locomotive function and forelimb strength in animal models of spinal cord injury, indicating its potential as a protective treatment.

In clinical settings, modest hypothermia has been found to be safe and achievable for severely injured spinal cord injury patients, supporting its use in acute treatment scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia for spinal cord injury. Dietrich, WD.[2009]

Systemic hypothermia has been shown to improve behavioral outcomes in traumatic spinal cord injury by an average of 24.5%, based on a systematic review and meta-analysis of high-quality studies.

Regional hypothermia also showed a potential benefit with a 26.2% improvement, but results were more variable, suggesting that factors like cooling depth and duration may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of therapeutic hypothermia in animal models of spinal cord injury. Batchelor, PE., Skeers, P., Antonic, A., et al.[2021]

In a study involving rats with spinal cord injuries, local hypothermia delivered 30 minutes post-injury did not improve tissue preservation, neuronal health, or locomotor recovery compared to control groups, indicating it may not be an effective treatment.

The research suggests that regional cooling could potentially worsen outcomes by reducing blood flow to the injured area, leading to increased secondary injury rather than providing protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of epidural hypothermic saline infusion on locomotor outcome and tissue preservation after moderate thoracic spinal cord contusion in rats. Casas, CE., Herrera, LP., Prusmack, C., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systemic hypothermia improves histological and functional outcome after cervical spinal cord contusion in rats. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical application of modest hypothermia after spinal cord injury. [2009]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Technique of selective spinal cord cooling in rat: methodology and application. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The role of therapeutic hypothermia in the management of acute spinal cord injury. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of local and general hypothermia on temperature profiles of the central nervous system following spinal cord injury in rats. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hypothermia Therapy for Traumatic Spinal Cord Injury: An Updated Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia for spinal cord injury. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of therapeutic hypothermia in animal models of spinal cord injury. [2021]

10. United States pubmed.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]