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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC150063 | Other Grant/Funding Number | United States Department of Defense | |
| 20160365 | Other Identifier | University of Miami IRB |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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).
The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the potential for clinical hypothermia following SCI to improve neurological outcome has significant value. Many patients suffering SCI become permanently dependent on caretakers and become a financial liability to both the family and society. Hypothermia has the potential to improve outcome so that more patients suffering SCI can regain independent motor and sensory function and remain economically productive members of society. The use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute SCI and may also have more widespread uses in patients presenting with stroke or cardiac arrest. In the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia | Experimental | Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours. |
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| Control | No Intervention | Standard of care medical treatment, specific to each individual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypothermia | Other | To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [510(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological improvement on American Spinal Injury Association (ASIA) | Improvement in ASIA Impairment Scale (AIS) after modest hypothermia | Between baseline and 12 months |
| Neurological improvement on ASIA | Improvement in ASIA motor score after modest hypothermia | Between baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement in Functional Independence Measure (FIM) | Functional improvement in FIM after modest hypothermia | 12 months |
| Functional improvement in Spinal Cord Independence Measure (SCIM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Jimsheleishvili, MD | Contact | 305-243-4781 | gxj150@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allan D Levi, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute with Barrow Brain and Spine | Recruiting | Phoenix | Arizona | 85027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20190669 | Background | Levi AD, Casella G, Green BA, Dietrich WD, Vanni S, Jagid J, Wang MY. Clinical outcomes using modest intravascular hypothermia after acute cervical spinal cord injury. Neurosurgery. 2010 Apr;66(4):670-7. doi: 10.1227/01.NEU.0000367557.77973.5F. | |
| 23247015 | Background | Dididze M, Green BA, Dietrich WD, Vanni S, Wang MY, Levi AD. Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. Spinal Cord. 2013 May;51(5):395-400. doi: 10.1038/sc.2012.161. Epub 2012 Dec 18. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007035 | Hypothermia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Functional improvement in SCIM after modest hypothermia
| 12 months |
| Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136 | United States |
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| Emory University School of Medicine | Terminated | Atlanta | Georgia | 30303-3049 | United States |
| Indiana University School of Medicine | Terminated | Indianapolis | Indiana | 46202-1000 | United States |
| University of Maryland School of Medicine | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107-5125 | United States |
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| Prisma Health - University of South Carolina | Recruiting | Columbia | South Carolina | 29203 | United States |
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| 19271964 | Background | Levi AD, Green BA, Wang MY, Dietrich WD, Brindle T, Vanni S, Casella G, Elhammady G, Jagid J. Clinical application of modest hypothermia after spinal cord injury. J Neurotrauma. 2009 Mar;26(3):407-15. doi: 10.1089/neu.2008.0745. |
| 35013548 | Background | Vedantam A, Jimsheleishvili G, Harrop JS, Alberga LR, Ahmad FU, Murphy RK, Jackson JB 3rd, Rodgers RB, Levi AD. A prospective multi-center study comparing the complication profile of modest systemic hypothermia versus normothermia for acute cervical spinal cord injury. Spinal Cord. 2022 Jun;60(6):510-515. doi: 10.1038/s41393-021-00747-w. Epub 2022 Jan 10. |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |