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

This study is currently recruiting participants.
Verified January 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Jean-Francois Pittet, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01897792
First received: July 9, 2013
Last updated: January 6, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 University of Alabama at Birmingham:

Primary Outcome Measures:
  • The incidence of coagulation abnormalities, total blood product transfusions and the incidence of organ injury and ventilator-associated pneumonia. [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    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 0, 2, 4, 6, 12, and 24 hours and daily thereafter for a total of 3 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).


Secondary Outcome Measures:
  • Protocol violations, 28- and 60-day mortality, ventilator-free days and duration of ICU and hospital stay. [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    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 0, 2, 4, 6, 12, and 24 hours and daily thereafter for a total of 3 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.


Estimated Enrollment: 700
Study Start Date: May 2013
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897792

Contacts
Contact: LaShun L. Horn, M.S. 205-996-2606 lashunh@uab.edu
Contact: Albert Pierce, II, M.D. 205-975-0163 bpierce@uab.edu

Locations
United States, Alabama
The University of Alabama at Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Jean-Francois Pittet, M.D.         
Principal Investigator: Jeffrey Kerby, M.D., Ph.D.         
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
Study First Received: July 9, 2013
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014