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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status and phase

Terminated
Phase 2

Conditions

Coagulopathy
Nosocomial Pneumonia

Treatments

Drug: Placebo (for Vitamin E)
Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin C
Dietary Supplement: Saline (for Vitamin C)

Study type

Interventional

Funder types

Other

Identifiers

NCT01897792
F101108001

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

11 participants in 2 patient groups, including a placebo group

Vitamins C and E
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin C
0.9% saline and sugar pill
Placebo Comparator group
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.
Treatment:
Drug: Placebo (for Vitamin E)
Dietary Supplement: Saline (for Vitamin C)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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