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Inability to recruit patients that meet inclusion criteria.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamins C and E | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Dietary Supplement |
|
| |
| Vitamin E |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to 3 days |
| Number of Subjects With Ventilator-associated Pneumonia. | Number of subjects diagnosed with pneumonia and requiring ventilator support. | From enrollment to 3 days |
| Number of Subjects With Organ Injury | Any injury to internal organs (thoracic, abdominal or cranial cavity) | 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. | From enrollment to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment up to 60 days post enrollment |
| Number of Subjects Surviving to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Francois Pittet, M.D. | The University of Alabama at Birmingham | Principal Investigator |
| Jeffrey Kerby, M.D., Ph.D. | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17457176 | Background | 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. | |
| 18469643 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamins C and 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. Vitamin C Vitamin E |
| FG001 | 0.9% Saline and Sugar Pill | 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. Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamins C and 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. Vitamin C Vitamin E |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | From enrollment up to 3 days |
|
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No adverse events were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamins C and 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. Vitamin C Vitamin E |
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Study terminated--inability to recruit patient that met inclusion criteria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Francois Pittet, MD | UAB Department of Anesthesiology | 205-996-4755 | jpittet@uabmc.edu |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dietary Supplement |
|
|
| Saline (for Vitamin C) | Dietary Supplement | 0.9% saline administered to mimic Vitamin C |
|
| Placebo (for Vitamin E) | Drug | Sugar pill administered to mimic Vitamin E |
|
Number of subjects that survived to day 28 after enrollment
| from enrollment up to 28 days post enrollment |
| Number of Subjects With 60-day Survival | Number of subjects in each arm that survived to day 60 | from enrollment up to 60 days post enrollment |
| Mean Number of Ventilator-free Days for Subjects | The mean number of ventilator free days (not on ventilator) for subjects in each arm | from enrollment up to 60 days post enrollment |
| Mean Number of Days in ICU. | the mean number of days each subject was in the ICU in each arm | from enrollment up to 60 days post enrollment |
| Mean Number of Hospital Stay Days. | The mean number of days subjects were in the hospital in each arm of the study | from enrollment up to 60 days post enrollment |
| 19333141 | Background | 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. |
| 20009664 | Background | 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. |
| 12454520 | Background | 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. |
| 18596309 | Background | 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. |
| 20689935 | Background | 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. |
| 12813333 | Background | 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. |
| 12855879 | Background | 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. |
| 12970121 | Background | Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. doi: 10.1378/chest.124.3_suppl.26s. |
| 20149369 | Background | 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. |
| 0.9% Saline and Sugar Pill |
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. Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 0.9% Saline and Sugar Pill |
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. Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E |
|
|
| Primary | Number of Subjects With Ventilator-associated Pneumonia. | Number of subjects diagnosed with pneumonia and requiring ventilator support. | Posted | Number | participants | From enrollment to 3 days |
|
|
|
| Primary | Number of Subjects With Organ Injury | Any injury to internal organs (thoracic, abdominal or cranial cavity) | Posted | Number | participants | From enrollment to 3 days |
|
|
|
| Primary | Number of Total Blood Product Transfusions | the number of blood product transfusions for all subjects in each group over the course of 3 days. | Posted | Number | blood transfusions | From enrollment to 3 days |
|
|
|
| Secondary | 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. | Posted | Number | protocol deviations | from enrollment up to 60 days post enrollment |
|
|
|
| Secondary | Number of Subjects Surviving to Day 28 | Number of subjects that survived to day 28 after enrollment | Posted | Number | participants | from enrollment up to 28 days post enrollment |
|
|
|
| Secondary | Number of Subjects With 60-day Survival | Number of subjects in each arm that survived to day 60 | Posted | Number | participants | from enrollment up to 60 days post enrollment |
|
|
|
| Secondary | Mean Number of Ventilator-free Days for Subjects | The mean number of ventilator free days (not on ventilator) for subjects in each arm | Posted | Mean | Full Range | days | from enrollment up to 60 days post enrollment |
|
|
|
| Secondary | Mean Number of Days in ICU. | the mean number of days each subject was in the ICU in each arm | Posted | Mean | Full Range | days | from enrollment up to 60 days post enrollment |
|
|
|
| Secondary | Mean Number of Hospital Stay Days. | The mean number of days subjects were in the hospital in each arm of the study | Posted | Mean | Full Range | days | from enrollment up to 60 days post enrollment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 0.9% Saline and Sugar Pill | 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. Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E | 0 | 0 | 0 | 0 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |