Status:
TERMINATED
Thermogard™ Efficacy Trial
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Hypothermia
Burns
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the Thermogard™ central venous catheter can prevent hypothermia (defined as a core body temperature less then 36.0 °C) in severely burned patients who are ...
Detailed Description
Hypothermia in the severely burned has been shown to disrupt coagulation, impair myocardial function, weaken the host immune response, delay wound healing and increase mortality. Current methods avai...
Eligibility Criteria
Inclusion
- Adult males and non-pregnant females ages 18-70 with greater than 20% TBSA burns requiring excision and grafting and in need of a central venous catheter per ICU admission criteria.
- Patient or patient's surrogate must be able to verbalize understanding and willingness to participate in the study and provide written informed consent
Exclusion
- Pregnancy. All females admitted to the burn ICU undergo routine serum hCG to determine pregnancy status. Those found to be pregnant will be excluded from entry into the study
- Burn patients enrolled in recombinant Factor VII study due to the theoretical increased risk for clot formation
- Basic and advanced enlisted trainees
- Age greater than 70 years old due to increased mortality rate among those severely burned
- Conditions which make placement of a central venous catheters a greater than normal risk (vascular anomalies, previous vascular surgery, etc.)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00822796
Start Date
September 1 2008
End Date
October 1 2009
Last Update
July 24 2013
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