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Hypothermia for Spinal Cord Injury

N/A
Recruiting
Led By Allan D Levi, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 - 70 years of age
AIS Grade A - C
Must not have
Age > 70 years
Severe bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of cooling the body after a spinal cord injury.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include risks associated with lowering body temperature such as shivering, increased blood clotting risk, infection risk due to immune system suppression by cold temperatures, changes in heart rhythm or rate, and possible impacts on other organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My spinal cord injury is classified between Grade A and C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am over 70 years old.
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I have severe bleeding.
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My spinal cord is completely severed.
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I have some motor function below the level of injury.
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I have a blood disorder.
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I have Reynaud's syndrome.
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I have pancreatitis.
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I have a history of serious heart problems.
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I have a blood clotting disorder.
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I have a low platelet count.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurological improvement on ASIA
Neurological improvement on American Spinal Injury Association (ASIA)
Secondary study objectives
Functional improvement in Functional Independence Measure (FIM)
Functional improvement in Spinal Cord Independence Measure (SCIM)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
955 Previous Clinical Trials
428,733 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,597 Total Patients Enrolled
Allan D Levi, MD, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
7,000 Total Patients Enrolled

Media Library

Modest Intravascular Hypothermia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02991690 — N/A
Spinal Cord Injury Research Study Groups: Hypothermia, Control
Spinal Cord Injury Clinical Trial 2023: Modest Intravascular Hypothermia Highlights & Side Effects. Trial Name: NCT02991690 — N/A
Modest Intravascular Hypothermia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02991690 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02991690 — N/A
~9 spots leftby Aug 2025
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