Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
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|ClinicalTrials.gov Identifier: NCT01897792|
Recruitment Status : Terminated (Inability to recruit patients that meet inclusion criteria.)
First Posted : July 12, 2013
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coagulopathy Nosocomial Pneumonia||Dietary Supplement: Vitamin C Dietary Supplement: Vitamin E Dietary Supplement: Saline (for Vitamin C) Drug: Placebo (for Vitamin E)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma|
|Study Start Date :||May 2013|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Experimental: Vitamins C and E
Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Dietary Supplement: Vitamin C
Other Name: ascorbic acidDietary Supplement: Vitamin E
Other Name: alpha-tocopherol
Placebo Comparator: 0.9% saline and sugar pill
100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Dietary Supplement: Saline (for Vitamin C)
0.9% saline administered to mimic Vitamin CDrug: Placebo (for Vitamin E)
Sugar pill administered to mimic Vitamin E
- Number of Participants With Coagulation Abnormalities [ Time Frame: From enrollment up to 3 days ]Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.
- Number of Subjects With Ventilator-associated Pneumonia. [ Time Frame: From enrollment to 3 days ]Number of subjects diagnosed with pneumonia and requiring ventilator support.
- Number of Subjects With Organ Injury [ Time Frame: From enrollment to 3 days ]Any injury to internal organs (thoracic, abdominal or cranial cavity)
- Number of Total Blood Product Transfusions [ Time Frame: From enrollment to 3 days ]the number of blood product transfusions for all subjects in each group over the course of 3 days.
- Number of Protocol Violations Per Arm. [ Time Frame: from enrollment up to 60 days post enrollment ]The number of times that there was a deviation or violation from how the protocol was to be implemented.
- Number of Subjects Surviving to Day 28 [ Time Frame: from enrollment up to 28 days post enrollment ]Number of subjects that survived to day 28 after enrollment
- Number of Subjects With 60-day Survival [ Time Frame: from enrollment up to 60 days post enrollment ]Number of subjects in each arm that survived to day 60
- Mean Number of Ventilator-free Days for Subjects [ Time Frame: from enrollment up to 60 days post enrollment ]The mean number of ventilator free days (not on ventilator) for subjects in each arm
- Mean Number of Days in ICU. [ Time Frame: from enrollment up to 60 days post enrollment ]the mean number of days each subject was in the ICU in each arm
- Mean Number of Hospital Stay Days. [ Time Frame: from enrollment up to 60 days post enrollment ]The mean number of days subjects were in the hospital in each arm of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897792
|United States, Alabama|
|The University of Alabama at Birmingham Hospital|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Jean-Francois Pittet, M.D.||The University of Alabama at Birmingham|
|Principal Investigator:||Jeffrey Kerby, M.D., Ph.D.||The University of Alabama at Birmingham|