Systemic Hypothermia in Acute Cervical Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypothermia.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury, Acute. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- Neurological improvement on American Spinal Injury Association (ASIA) [Time frame: Between baseline and 12 months]
- Neurological improvement on ASIA [Time frame: Between baseline and 12 months]
Secondary outcome measures (2)
- Functional improvement in Functional Independence Measure (FIM) [Time frame: 12 months]
- Functional improvement in Spinal Cord Independence Measure (SCIM) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- HonorHealth Research Institute with Barrow Brain and Spine — Phoenix
- Jackson Memorial Hospital — Miami
- Emory University School of Medicine — Atlanta
- Indiana University School of Medicine — Indianapolis
- University of Maryland School of Medicine — Baltimore
- Thomas Jefferson University — Philadelphia
- Prisma Health - University of South Carolina — Columbia
Publications
- 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. PMID 20190669
- 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. PMID 23247015
- 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. PMID 19271964
- 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. PMID 35013548
Identifiers
NCT: NCT02991690 · 20160758 · CDMRP-SC150063 · 20160365