Hypothermia for Spinal Cord Injury
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?
Is hypothermia treatment generally safe for humans?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Intravascular hypothermia initiated within 24 hours post-injury and maintained at 33 degrees Celsius for 48 hours
Follow-up
Participants are monitored for neurological and functional improvements
Treatment Details
Interventions
- Modest Intravascular Hypothermia
Modest Intravascular Hypothermia is already approved in European Union, United States, Canada, Japan for the following indications:
- Cardiac Arrest
- Neonatal Encephalopathy
- Stroke
- Cardiac Arrest
- Neonatal Encephalopathy
- Stroke
- Spinal Cord Injury
- Cardiac Arrest
- Neonatal Encephalopathy
- Stroke
- Cardiac Arrest
- Neonatal Encephalopathy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
United States Department of Defense
Collaborator