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

Primary Purpose

Coagulopathy, Nosocomial Pneumonia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Vitamin E
Saline (for Vitamin C)
Placebo (for Vitamin E)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coagulopathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamins C and E

0.9% saline and sugar pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Coagulation Abnormalities
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.
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Number of Subjects With Organ Injury
Any injury to internal organs (thoracic, abdominal or cranial cavity)
Number of Total Blood Product Transfusions
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.
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
Number of subjects that survived to day 28 after enrollment
Number of Subjects With 60-day Survival
Number of subjects in each arm that survived to day 60
Mean Number of Ventilator-free Days for Subjects
The mean number of ventilator free days (not on ventilator) for subjects in each arm
Mean Number of Days in ICU.
the mean number of days each subject was in the ICU in each arm
Mean Number of Hospital Stay Days.
The mean number of days subjects were in the hospital in each arm of the study

Full Information

First Posted
July 9, 2013
Last Updated
February 8, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01897792
Brief Title
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
Official Title
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit patients that meet inclusion criteria.
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulopathy, Nosocomial Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamins C and E
Arm Type
Experimental
Arm Description
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.
Arm Title
0.9% saline and sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
alpha-tocopherol
Intervention Type
Dietary Supplement
Intervention Name(s)
Saline (for Vitamin C)
Intervention Description
0.9% saline administered to mimic Vitamin C
Intervention Type
Drug
Intervention Name(s)
Placebo (for Vitamin E)
Intervention Description
Sugar pill administered to mimic Vitamin E
Primary Outcome Measure Information:
Title
Number of Participants With Coagulation Abnormalities
Description
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.
Time Frame
From enrollment up to 3 days
Title
Number of Subjects With Ventilator-associated Pneumonia.
Description
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Time Frame
From enrollment to 3 days
Title
Number of Subjects With Organ Injury
Description
Any injury to internal organs (thoracic, abdominal or cranial cavity)
Time Frame
From enrollment to 3 days
Title
Number of Total Blood Product Transfusions
Description
the number of blood product transfusions for all subjects in each group over the course of 3 days.
Time Frame
From enrollment to 3 days
Secondary Outcome Measure Information:
Title
Number of Protocol Violations Per Arm.
Description
The number of times that there was a deviation or violation from how the protocol was to be implemented.
Time Frame
from enrollment up to 60 days post enrollment
Title
Number of Subjects Surviving to Day 28
Description
Number of subjects that survived to day 28 after enrollment
Time Frame
from enrollment up to 28 days post enrollment
Title
Number of Subjects With 60-day Survival
Description
Number of subjects in each arm that survived to day 60
Time Frame
from enrollment up to 60 days post enrollment
Title
Mean Number of Ventilator-free Days for Subjects
Description
The mean number of ventilator free days (not on ventilator) for subjects in each arm
Time Frame
from enrollment up to 60 days post enrollment
Title
Mean Number of Days in ICU.
Description
the mean number of days each subject was in the ICU in each arm
Time Frame
from enrollment up to 60 days post enrollment
Title
Mean Number of Hospital Stay Days.
Description
The mean number of days subjects were in the hospital in each arm of the study
Time Frame
from enrollment up to 60 days post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Pittet, M.D.
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Kerby, M.D., Ph.D.
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17457176
Citation
Brohi K, Cohen MJ, Ganter MT, Matthay MA, Mackersie RC, Pittet JF. Acute traumatic coagulopathy: initiated by hypoperfusion: modulated through the protein C pathway? Ann Surg. 2007 May;245(5):812-8. doi: 10.1097/01.sla.0000256862.79374.31.
Results Reference
background
PubMed Identifier
18469643
Citation
Brohi K, Cohen MJ, Ganter MT, Schultz MJ, Levi M, Mackersie RC, Pittet JF. Acute coagulopathy of trauma: hypoperfusion induces systemic anticoagulation and hyperfibrinolysis. J Trauma. 2008 May;64(5):1211-7; discussion 1217. doi: 10.1097/TA.0b013e318169cd3c.
Results Reference
background
PubMed Identifier
19333141
Citation
Chesebro BB, Rahn P, Carles M, Esmon CT, Xu J, Brohi K, Frith D, Pittet JF, Cohen MJ. Increase in activated protein C mediates acute traumatic coagulopathy in mice. Shock. 2009 Dec;32(6):659-65. doi: 10.1097/SHK.0b013e3181a5a632.
Results Reference
background
PubMed Identifier
20009664
Citation
Cohen MJ, Bir N, Rahn P, Dotson R, Brohi K, Chesebro BB, Mackersie R, Carles M, Wiener-Kronish J, Pittet JF. Protein C depletion early after trauma increases the risk of ventilator-associated pneumonia. J Trauma. 2009 Dec;67(6):1176-81. doi: 10.1097/TA.0b013e3181c1c1bc.
Results Reference
background
PubMed Identifier
12454520
Citation
Nathens AB, Neff MJ, Jurkovich GJ, Klotz P, Farver K, Ruzinski JT, Radella F, Garcia I, Maier RV. Randomized, prospective trial of antioxidant supplementation in critically ill surgical patients. Ann Surg. 2002 Dec;236(6):814-22. doi: 10.1097/00000658-200212000-00014.
Results Reference
background
PubMed Identifier
18596309
Citation
Collier BR, Giladi A, Dossett LA, Dyer L, Fleming SB, Cotton BA. Impact of high-dose antioxidants on outcomes in acutely injured patients. JPEN J Parenter Enteral Nutr. 2008 Jul-Aug;32(4):384-8. doi: 10.1177/0148607108319808.
Results Reference
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PubMed Identifier
20689935
Citation
Secor D, Li F, Ellis CG, Sharpe MD, Gross PL, Wilson JX, Tyml K. Impaired microvascular perfusion in sepsis requires activated coagulation and P-selectin-mediated platelet adhesion in capillaries. Intensive Care Med. 2010 Nov;36(11):1928-34. doi: 10.1007/s00134-010-1969-3. Epub 2010 Aug 6.
Results Reference
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PubMed Identifier
12813333
Citation
Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.
Results Reference
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PubMed Identifier
12855879
Citation
MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003 Jul;55(1):39-44. doi: 10.1097/01.TA.0000075338.21177.EF.
Results Reference
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PubMed Identifier
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Citation
Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. doi: 10.1378/chest.124.3_suppl.26s.
Results Reference
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PubMed Identifier
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Citation
Giladi AM, Dossett LA, Fleming SB, Abumrad NN, Cotton BA. High-dose antioxidant administration is associated with a reduction in post-injury complications in critically ill trauma patients. Injury. 2011 Jan;42(1):78-82. doi: 10.1016/j.injury.2010.01.104. Epub 2010 Feb 10.
Results Reference
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Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

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