Hypothermia for Hypothermia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hypothermia+3 More
Hypothermia - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Hypothermia
  • Spinal Cord

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 12 months

12 months
Functional improvement in Functional Independence Measure (FIM)
Functional improvement in Spinal Cord Independence Measure (SCIM)
Month 12
Neurological improvement on ASIA
Neurological improvement on American Spinal Injury Association (ASIA)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Hypothermia
1 of 2
Active Control
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Hypothermia · No Placebo Group · N/A

Hypothermia
Other
Experimental Group · 1 Intervention: Hypothermia · Intervention Types: Other
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

University of MiamiLead Sponsor
787 Previous Clinical Trials
384,290 Total Patients Enrolled
2 Trials studying Hypothermia
60 Patients Enrolled for Hypothermia
United States Department of DefenseFED
767 Previous Clinical Trials
202,285 Total Patients Enrolled
2 Trials studying Hypothermia
346 Patients Enrolled for Hypothermia
Allan D Levi, MD, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
7,000 Total Patients Enrolled
1 Trials studying Hypothermia
41 Patients Enrolled for Hypothermia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with a non-penetrating injury.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References