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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coagulopathy, Nosocomial Pneumonia

Intervention / Treatment
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* Dietary Supplement: Vitamin C
* Dietary Supplement: Vitamin E
* Dietary Supplement: Saline (for Vitamin C)
* Drug: Placebo (for Vitamin E)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamins C and E<br>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<br> <br> * Other names: ascorbic acid;Dietary Supplement: Vitamin E<br> <br> * Other names: alpha-tocopherol;|
| Placebo Comparator: 0.9% saline and sugar pill<br>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)<br>* 0.9% saline administered to mimic Vitamin C<br>Drug: Placebo (for Vitamin E)<br>* Sugar pill administered to mimic Vitamin E<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From enrollment up to 3 days | 
| Number of Subjects With Ventilator-associated Pneumonia. | Number of subjects diagnosed with pneumonia and requiring ventilator support. | From enrollment to 3 days | 
| Number of Subjects With Organ Injury | Any injury to internal organs (thoracic, abdominal or cranial cavity) | From enrollment to 3 days | 
| Number of Total Blood Product Transfusions | the number of blood product transfusions for all subjects in each group over the course of 3 days. | From enrollment to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from enrollment up to 60 days post enrollment | 
| Number of Subjects Surviving to Day 28 | Number of subjects that survived to day 28 after enrollment | from enrollment up to 28 days post enrollment | 
| Number of Subjects With 60-day Survival | Number of subjects in each arm that survived to day 60 | from enrollment up to 60 days post enrollment | 
| Mean Number of Ventilator-free Days for Subjects | The mean number of ventilator free days (not on ventilator) for subjects in each arm | from enrollment up to 60 days post enrollment | 
| Mean Number of Days in ICU. | the mean number of days each subject was in the ICU in each arm | from enrollment up to 60 days post enrollment | 
| Mean Number of Hospital Stay Days. | The mean number of days subjects were in the hospital in each arm of the study | from enrollment up to 60 days post enrollment |