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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
Sponsor:
Information provided by (Responsible Party):
Jean-Francois Pittet, University of Alabama at Birmingham

July 9, 2013
July 12, 2013
October 27, 2015
March 29, 2017
March 29, 2017
May 2013
February 2015   (Final data collection date for primary outcome measure)
  • 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.
The incidence of coagulation abnormalities, total blood product transfusions and the incidence of organ injury and ventilator-associated pneumonia. [ Time Frame: up to 5 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). Blood samples are collected upon arrival in the emergency department and at 6, 12, and 24 hours and daily thereafter for a total of 5 days and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of ventilator-associated pneumonia (VAP).
Complete list of historical versions of study NCT01897792 on ClinicalTrials.gov Archive Site
  • 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
Protocol violations, 28- and 60-day mortality, ventilator-free days and duration of ICU and hospital stay. [ Time Frame: up to 5 days ]
Coagulation parameters are evaluated using standard functional tests (PT, PTT, fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). Blood samples are collected upon arrival in the emergency department and at 6, 12, and 24 hours and daily thereafter for a total of 5 days and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of VAP.
Not Provided
Not Provided
 
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Coagulopathy
  • Nosocomial Pneumonia
  • Dietary Supplement: Vitamin C
    Other Name: ascorbic acid
  • Dietary Supplement: Vitamin E
    Other Name: alpha-tocopherol
  • Dietary Supplement: Saline (for Vitamin C)
    0.9% saline administered to mimic Vitamin C
  • Drug: Placebo (for Vitamin E)
    Sugar pill administered to mimic Vitamin E
  • 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.
    Interventions:
    • Dietary Supplement: Vitamin C
    • Dietary Supplement: Vitamin E
  • 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.
    Interventions:
    • Dietary Supplement: Saline (for Vitamin C)
    • Drug: Placebo (for Vitamin E)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
700
February 2015
February 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham (UAB) Hospital
  • Blunt or penetrating injury
  • UAB highest trauma activation

Exclusion Criteria:

  • Age < 19 years of age
  • Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication
  • Patients with known liver disease
  • Minor patients
  • Pregnant patients (known or suspected pregnancy)
  • Patients who are incarcerated
  • Patients who lack a surrogate
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01897792
F101108001
Yes
Not Provided
Not Provided
Jean-Francois Pittet, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
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
University of Alabama at Birmingham
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP