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
Other trials for Hypothermia
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
Other trials for Hypothermia
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: OtherControlNoIntervention 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 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
- Levi, Allan D., Gizelda Casella, Barth A. Green, W. Dalton Dietrich, Steven Vanni, Jonathan Jagid, and Michael Y. Wang. 2010. “Clinical Outcomes Using Modest Intravascular Hypothermia After Acute Cervical Spinal Cord Injury”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/01.neu.0000367557.77973.5f.
- Dididze, M, B A Green, W Dalton Dietrich, S Vanni, M Y Wang, and A D Levi. 2012. “Systemic Hypothermia in Acute Cervical Spinal Cord Injury: A Case-controlled Study”. Spinal Cord. Springer Science and Business Media LLC. doi:10.1038/sc.2012.161.
- Levi, Allan D., Barth A. Green, Michael Y. Wang, W. Dalton Dietrich, Ted Brindle, Steven Vanni, Gizelda Casella, Gina Elhammady, and Jonathan Jagid. 2009. “Clinical Application of Modest Hypothermia After Spinal Cord Injury”. Journal of Neurotrauma. Mary Ann Liebert Inc. doi:10.1089/neu.2008.0745.
- Vedantam, Aditya, George Jimsheleishvili, James S. Harrop, Linda R. Alberga, Faiz U. Ahmad, Rory K. Murphy, J. Benjamin Jackson III, Richard B. Rodgers, and Allan D. Levi. 2022. “A Prospective Multi-center Study Comparing the Complication Profile of Modest Systemic Hypothermia Versus Normothermia for Acute Cervical Spinal Cord Injury”. Spinal Cord. Springer Science and Business Media LLC. doi:10.1038/s41393-021-00747-w.
- Vedantam, Aditya, George Jimsheleishvili, James S. Harrop, Linda R. Alberga, Faiz U. Ahmad, Rory K. Murphy, J. Benjamin Jackson III, Richard B. Rodgers, and Allan D. Levi. 2022. “A Prospective Multi-center Study Comparing the Complication Profile of Modest Systemic Hypothermia Versus Normothermia for Acute Cervical Spinal Cord Injury”. Spinal Cord. Springer Science and Business Media LLC. doi:10.1038/s41393-021-00747-w.
- Vedantam, Aditya, George Jimsheleishvili, James S. Harrop, Linda R. Alberga, Faiz U. Ahmad, Rory K. Murphy, J. Benjamin Jackson III, Richard B. Rodgers, and Allan D. Levi. 2022. “A Prospective Multi-center Study Comparing the Complication Profile of Modest Systemic Hypothermia Versus Normothermia for Acute Cervical Spinal Cord Injury”. Spinal Cord. Springer Science and Business Media LLC. doi:10.1038/s41393-021-00747-w.
- Allan D. Levi 2017. "Systemic Hypothermia in Acute Cervical Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02991690.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments