Normothermia Protocol for Traumatic Brain Injury Patients

Medivance

Status: Unknown

Conditions: Traumatic Brain Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT01354509

MDV_STL_001

Details and patient eligibility

About

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)

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Current protocol group

Description:

Patients treated with current standards based on physician discretion.

Normothermia group

Description:

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