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

Phase 2TerminatedNCT01897792

University of Alabama at Birmingham11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Coagulopathy Nosocomial Pneumonia

Interventions

Vitamin CDIETARY_SUPPLEMENT

Vitamin EDIETARY_SUPPLEMENT

Saline (for Vitamin C)DIETARY_SUPPLEMENT

0.9% saline administered to mimic Vitamin C

Placebo (for Vitamin E)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: From enrollment up to 3 days

Number of Subjects With Ventilator-associated Pneumonia.

Number of subjects diagnosed with pneumonia and requiring ventilator support.

Time frame: From enrollment to 3 days

Number of Subjects With Organ Injury

Any injury to internal organs (thoracic, abdominal or cranial cavity)

Time frame: 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.

Time frame: From enrollment to 3 days

Secondary Outcomes

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.

Time frame: 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

Time frame: from enrollment up to 28 days post enrollment

Number of Subjects With 60-day Survival

Data from ClinicalTrials.gov

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