Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 12, 2010 | ||||
| Last Updated Date | January 24, 2013 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Biological response as characterized by microarray analysis, selected cytokines, TNFα, IL-1, IL-6 [ Time Frame: Change from Baseline in Inflammatory Gene Activation at 24 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Biological response as characterized by microarray analysis, selected cytokines, TNFα, IL-1, IL-6 [ Time Frame: Cytokines at 24 hours and at 1 week ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01239680 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy | ||||
| Official Title ICMJE | Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy. | ||||
| Brief Summary | Overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield, in civilian life, or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. |
||||
| Detailed Description | Shock is a leading cause of death among American forces in battle, with many trauma victims dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the body's vital organs and tissues. Specifically, hemorrhagic shock results when blood vessels are physically damaged while septic shock results when microbes or microbial products enter the blood stream. Despite advances in medical science, including the development of improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the United States, is treated today largely as he or she would have been treated in 1970. The overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield (medical corpsmen, combat medics), in civilian life (Emergency Medical System), or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. This might be a Fire Support Specialist (FIST) team in a combat theater or a trauma center in the civilian health care system. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Hemorrhagic Shock | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01239680 | ||||
| Other Study ID Numbers ICMJE | 05-18 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Missouri, Kansas City | ||||
| Study Sponsor ICMJE | University of Missouri, Kansas City | ||||
| Collaborators ICMJE | Department of Defense | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Missouri, Kansas City | ||||
| Verification Date | January 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||