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Systemic Hypothermia in Acute Cervical Spinal Cord Injury

ConditionSpinal Cord Injury, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 - 70 years of age

AIS Grade A - C

Glasgow Coma Scale ≥14

Able to start hypothermia treatment within 24 hours of injury

Disqualifiers

Age > 70 years

AIS Grade D

Hyperthermia on admission (>38.5ºC)

Severe systemic injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alsius Icy CoolGuard® Catheter

    Device

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intravascular HypothermiaExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Neurological improvement on American Spinal Injury Association (ASIA)

Improvement in ASIA Impairment Scale (AIS) after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function

Time frame
Between baseline and 12 months
2

Neurological improvement on ASIA

Improvement in ASIA motor score after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function

Time frame
Between baseline and 12 months

Secondary outcomes

1

Functional improvement in Functional Independence Measure (FIM)

Functional improvement in FIM after modest hypothermia. FIM score 18-126, with higher scores indicating greater functional independence

Time frame
12 months
2

Functional improvement in Spinal Cord Independence Measure (SCIM)

Functional improvement in SCIM after modest hypothermia. SCIM score 0-100, with higher scores indicating greater independence in activities of daily living

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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