Clinical trial NCT01897792: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coagulopathy
Nosocomial Pneumonia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants With Coagulation Abnormalities
timeFrame: From enrollment up to 3 days
measure: Number of Subjects With Ventilator-associated Pneumonia.
timeFrame: From enrollment to 3 days
measure: Number of Subjects With Organ Injury
timeFrame: From enrollment to 3 days
measure: Number of Total Blood Product Transfusions
timeFrame: From enrollment to 3 days
Secondary outcomes:
measure: Number of Protocol Violations Per Arm.
timeFrame: from enrollment up to 60 days post enrollment
measure: Number of Subjects Surviving to Day 28
timeFrame: from enrollment up to 28 days post enrollment
measure: Number of Subjects With 60-day Survival
timeFrame: from enrollment up to 60 days post enrollment
measure: Mean Number of Ventilator-free Days for Subjects
timeFrame: from enrollment up to 60 days post enrollment
measure: Mean Number of Days in ICU.
timeFrame: from enrollment up to 60 days post enrollment
measure: Mean Number of Hospital Stay Days.
timeFrame: from enrollment up to 60 days post enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Hospital
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Jean-Francois Pittet, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Alabama at Birmingham
name: Jeffrey Kerby, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. doi: 10.1378/chest.124.3_suppl.26s.
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.