Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT02991690

Collaborator

United States Department of Defense (U.S. Fed)

120

Enrollment

Locations

Arms

83.9

Anticipated Duration (Months)

17.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury, Acute	Other: Hypothermia	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study

Actual Study Start Date :

Aug 4, 2017

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypothermia Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.	Other: Hypothermia 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.
No Intervention: Control Standard of care medical treatment, specific to each individual.

Arm

Intervention/Treatment

Experimental: Hypothermia

Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.

Other: Hypothermia

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.

No Intervention: Control

Standard of care medical treatment, specific to each individual.

Outcome Measures

Primary Outcome Measures

Neurological improvement on American Spinal Injury Association (ASIA) [Between baseline and 12 months]
Improvement in ASIA Impairment Scale (AIS) after modest hypothermia
Neurological improvement on ASIA [Between baseline and 12 months]
Improvement in ASIA motor score after modest hypothermia

Secondary Outcome Measures

Functional improvement in Functional Independence Measure (FIM) [12 months]
Functional improvement in FIM after modest hypothermia
Functional improvement in Spinal Cord Independence Measure (SCIM) [12 months]
Functional improvement in SCIM after modest hypothermia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 - 70 years of age
AIS Grade A - C
Glasgow Coma Scale ≥14
Able to start hypothermia treatment within 24 hours of injury
Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.

Exclusion Criteria:

Age > 70 years
AIS Grade D
Hyperthermia on admission (>38.5ºC)
Severe systemic injury
Severe bleeding
Pregnancy
Coagulopathy
Thrombocytopenia
Known prior severe cardiac history
Blood dyscrasia
Pancreatitis
Reynaud's syndrome
Cord transection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute with Barrow Brain and Spine	Phoenix	Arizona	United States	85027
2	Jackson Memorial Hospital	Miami	Florida	United States	33136
3	Emory University School of Medicine	Atlanta	Georgia	United States	30303-3049
4	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202-1000
5	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
6	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107-5125
7	Prisma Health - University of South Carolina	Columbia	South Carolina	United States	29203