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

Coagulopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01897792
• Other study ID #: F101108001
• Status: Terminated
• Phase: Phase 2
• First received: July 9, 2013
• Last updated: August 4, 2015
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders
• Nosocomial Pneumonia
• Pneumonia

Intervention

Dietary Supplement:
• Vitamin C

• Vitamin E

• Saline (for Vitamin C)
0.9% saline administered to mimic Vitamin C

Drug:
• Placebo (for Vitamin E)
Sugar pill administered to mimic Vitamin E

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. — View 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. — View 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. — View 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. — View Citation

Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of coagulation abnormalities, total blood product transfusions and the incidence of organ injury and ventilator-associated pneumonia.	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. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of ventilator-associated pneumonia (VAP).	up to 3 days	No
Secondary	Protocol violations, 28- and 60-day mortality, ventilator-free days and duration of ICU and hospital stay.	Coagulation parameters are evaluated using standard functional tests (PT, 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. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of VAP.	up to 3 days	No