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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01897792
First received: July 9, 2013
Last updated: August 19, 2014
Last verified: July 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). 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. 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). 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. 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: January 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: August 19, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014