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

Phase 2

Terminated

• Conditions: Coagulopathy; Nosocomial Pneumonia
• Interventions: Dietary Supplement: Vitamin C; Dietary Supplement: Saline (for Vitamin C); Dietary Supplement: Vitamin E; Drug: Placebo (for Vitamin E)

• Registration Number: NCT01897792
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2015-10-27
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Results First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamins C and E	Vitamin C	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.
Vitamins C and E	Vitamin 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.
0.9% saline and sugar pill	Saline (for Vitamin C)	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.
0.9% saline and sugar pill	Placebo (for Vitamin E)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Number of Days in ICU.	from enrollment up to 60 days post enrollment	the mean number of days each subject was in the ICU in each arm
Number of Subjects With 60-day Survival	from enrollment up to 60 days post enrollment	Number of subjects in each arm that survived to day 60
Number of Protocol Violations Per Arm.	from enrollment up to 60 days post enrollment	The number of times that there was a deviation or violation from how the protocol was to be implemented.
Mean Number of Ventilator-free Days for Subjects	from enrollment up to 60 days post enrollment	The mean number of ventilator free days (not on ventilator) for subjects in each arm
Mean Number of Hospital Stay Days.	from enrollment up to 60 days post enrollment	The mean number of days subjects were in the hospital in each arm of the study
Number of Subjects Surviving to Day 28	from enrollment up to 28 days post enrollment	Number of subjects that survived to day 28 after enrollment

Trial Locations

Locations (1)

The University of Alabama at Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States