Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Miami
Study ID
NCT02991690
Status
Recruiting
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Conditions

  • Spinal Cord Injury, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Aug 4, 2017
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Neurological improvement on American Spinal Injury Association (ASIA) [ Time Frame: Between baseline and 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute with Barrow Brain and SpinePhoenixArizona85027
Camille Fajardo, CCRC
[email protected]
623-879-1692
Jackson Memorial HospitalMiamiFlorida33136
George Jimsheleishvili, MD
305-243-4781
Emory University School of MedicineAtlantaGeorgia30303-3049-
Indiana University School of MedicineIndianapolisIndiana46202-1000-
University of Maryland School of MedicineBaltimoreMaryland21201
Leslie Sult, BSN, RN
[email protected]
410-328-3657
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-5125
James Harrop, MD
Prisma Health - University of South CarolinaColumbiaSouth Carolina29203
Paisley Myers, PhD
[email protected]
803-296-9274

Find similar trials in Phoenix, AZ

By research site
HonorHealth Research Institute with Barrow Brain and Spine· Phoenix, AZJackson Memorial Hospital· Miami, FLEmory University School of Medicine· Atlanta, GAIndiana University School of Medicine· Indianapolis, INUniversity of Maryland School of Medicine· Baltimore, MDThomas Jefferson University· Philadelphia, PA

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