Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Surgery
General health
Online since 3 November 2021, updated 896 days ago

About this trial

This trial is recruiting individuals with new cervical (neck area) spinal cord injuries to test whether cooling the body temperature will improve recovery of strength and sensation. Cooling is achieved by placing a thin tube (catheter) into a large blood vessel of the leg. Cold liquid circulates in the tube, thus cooling blood flowing past it. As blood then circulates throughout the body, overall body temperature is lowered (intravascular hypothermia). The main goals of the study are to see if cooling is safe, whether it reduces spinal cord damage, and whether it improves recovery. Participants will be randomly assigned to either have a blood vessel tube inserted in the leg to cool body temperature down to 33°C for 48 hours, or will receive standard medical care (no cooling).

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≤ 24 hours
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-C8

    What’s involved

    Type

    Surgery

    Details

    If in the intervention group, the participant will have a thin tube put into a blood vessel in their leg to cool their blood down to 33°C for 48 hours. Neurological examination 12 months after the intervention.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health and psychosocial factors

    Sensory function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 4 Aug 2017
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 4 Aug 2017
    • Organisation
    • University of Miami

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more