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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neurological improvement on ASIA

Neurological improvement on American Spinal Injury Association (ASIA)

Secondary outcome measures

Functional improvement in Functional Independence Measure (FIM)

Functional improvement in Spinal Cord Independence Measure (SCIM)

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,896 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,579 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants satisfy in order to join this trial?

"This clinical trial is searching for 120 people between 18 and 70 years of age who are currently suffering from hypothermia. The inclusion criteria also demand that patients must have an Abbreviated Injury Scale Grade A - C, a Glasgow Coma Scale score higher than or equal to 14, the capacity to start treatment within 24 hours post-injury, and non-penetrating wounds. Importantly, those requiring rapid surgical reduction may still qualify."

Answered by AI

Is participation in this trial restricted to those aged 70 or under?

"This medical study seeks out participants that are between 18 and 70 years old."

Answered by AI

How many locations have been set up to administer this experiment?

"Patients can enrol in this trial at Jackson Memorial Hospital (Miami, FL), Prisma Health - University of South carolina (Columbia, SC) and Thomas Jefferson Univeristy (Philadelphia, PA). Additionally there are 3 other sites where participants may register."

Answered by AI

How many test subjects are involved in this clinical investigation?

"This clinical trial requires 120 patient volunteers, who meet the stated requirements, to take part. Jackson Memorial Hospital in Miami and Prisma Health - University of South carolina in Columbia are two sites currently recruiting participants."

Answered by AI

Does this clinical trial currently have openings for participants?

"Affirmative. The clinical trial in question is still actively recruiting candidates, having first been posted on August 4th 2017 and updated most recently on October 7th 2022. An aggregate of 120 individuals are needed to be enrolled from 6 different medical centres."

Answered by AI