Normothermia Protocol for Traumatic Brain Injury Patients

Traumatic Brain Injury Clinical Trial

Official title:

Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01354509
• Other study ID #: MDV_STL_001
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2011
• Last updated: May 17, 2011
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2011
• Source: Medivance, Inc.
• Contact: Farid Sadaka, MD
• Phone: 214-251-6486
• Email: farid.sadaka[@]mercy.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Mercy St John's Medical Center	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Medivance, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the Normothermia protocol	Number of times patient's temp was above 37°C during this 96 hr period	5 days	No
Primary	Temperature vs ICP	Number of times ICP > 20 in patients with ICP monitors	5 days	No
Primary	Neurologic Outcome of the 2 patient populations	Modified Rankin Scale at Hospital discharge, 3 months, and 6 months	1month, 3 months, 6 months	No
Secondary	Mortality	In-Hospital mortality, 3 - 6 month mortality	5 days, 3 months, 6 months	No