Recruiting

Normothermia vs. Acetaminophen

Sponsor:

Medivance, Inc.

Code:

NCT01354509

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)

1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU)
2. Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)

Conditions

Traumatic Brain Injury

Study ID

NCT01354509

Start date

May, 2011

Status verified date

May, 2011

Completion date

May, 2013

Anticipated

Primary completion date

May, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Severe TBI patients(GCS 3-9) admitted to ICU

Exclusion Criteria:

  • Less than 18 years OLD.
  • Bleeding disorders.
  • Pregnancy/Breastfeeding.
  • Hepatic Encephalopathy.
  • Spinal cord injury (know or new)
  • Fever >100 F prior to randomization.
  • Blood Alcohol level >80
  • Participation in other Research trial.
  • Inability/unwilling to obtain Informed consent.
  • Terminal illness(not expected to survive 3-6 months)
  • Not expected to survive 24 hrs.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Current protocol group

Patients treated with current standards based on physician discretion.

Normothermia group

Normothermia protocol, using Hydrogel cooling Pads(Arctic Sun) applied for 96 hrs starting upon admission to the ICU

Primary outcome measure

  • Effectiveness of the Normothermia protocol [ Time Frame: 5 days ]
  • Temperature vs ICP [ Time Frame: 5 days ]
  • Neurologic Outcome of the 2 patient populations [ Time Frame: 1month, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Farid Sadaka, MD

214-251-6486farid.sadaka@mercy.net

Catherine Krause, RN

314-251-5653krauca@mercy.net

Locations

Mercy St John's Medical Center

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Farid Sadaka, MD

214-251-6486farid.sadaka@mercy.net

Catherine Krause, RN

314-251-5653krauca@mercy.net

More Information

Sponsor

Medivance, Inc.

Last update posted

May 18, 2011

Last verified

May, 2011

Keywords

  • Normothermia
  • fever control
  • Outcome study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medivance, Inc. on 2011-05-18.