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Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

This study has been terminated.
(Inability to recruit patients that meet inclusion criteria.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897792
First Posted: July 12, 2013
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean-Francois Pittet, University of Alabama at Birmingham
  Purpose
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.

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

Resource links provided by NLM:


Further study details as provided by Jean-Francois Pittet, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 11
Study Start Date: May 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 acid
Dietary 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 C
Drug: Placebo (for Vitamin E)
Sugar pill administered to mimic Vitamin E

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Alabama
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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
  More Information

Publications:

Responsible Party: Jean-Francois Pittet, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01897792     History of Changes
Other Study ID Numbers: F101108001
First Submitted: July 9, 2013
First Posted: July 12, 2013
Results First Submitted: October 27, 2015
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Pneumonia
Blood Coagulation Disorders
Hemostatic Disorders
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents