Trial Outcomes & Findings for Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma (NCT NCT01897792)
NCT ID: NCT01897792
Last Updated: 2017-03-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From enrollment up to 3 days
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
Baseline characteristics by cohort
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 3 daysCoagulation 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.
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Participants With Coagulation Abnormalities
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: From enrollment to 3 daysNumber of subjects diagnosed with pneumonia and requiring ventilator support.
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Subjects With Ventilator-associated Pneumonia.
|
4 participants
|
2 participants
|
PRIMARY outcome
Timeframe: From enrollment to 3 daysAny injury to internal organs (thoracic, abdominal or cranial cavity)
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Subjects With Organ Injury
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From enrollment to 3 daysthe number of blood product transfusions for all subjects in each group over the course of 3 days.
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Total Blood Product Transfusions
|
11 blood transfusions
|
5 blood transfusions
|
SECONDARY outcome
Timeframe: from enrollment up to 60 days post enrollmentThe number of times that there was a deviation or violation from how the protocol was to be implemented.
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Protocol Violations Per Arm.
|
1 protocol deviations
|
0 protocol deviations
|
SECONDARY outcome
Timeframe: from enrollment up to 28 days post enrollmentNumber of subjects that survived to day 28 after enrollment
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Subjects Surviving to Day 28
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: from enrollment up to 60 days post enrollmentNumber of subjects in each arm that survived to day 60
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Number of Subjects With 60-day Survival
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: from enrollment up to 60 days post enrollmentThe mean number of ventilator free days (not on ventilator) for subjects in each arm
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Mean Number of Ventilator-free Days for Subjects
|
12 days
Interval 2.0 to 23.0
|
6.2 days
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: from enrollment up to 60 days post enrollmentthe mean number of days each subject was in the ICU in each arm
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Mean Number of Days in ICU.
|
15 days
Interval 3.0 to 30.0
|
11 days
Interval 4.0 to 20.0
|
SECONDARY outcome
Timeframe: from enrollment up to 60 days post enrollmentThe mean number of days subjects were in the hospital in each arm of the study
Outcome measures
| Measure |
Vitamins C and E
n=6 Participants
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
|
0.9% Saline and Sugar Pill
n=5 Participants
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
|
|---|---|---|
|
Mean Number of Hospital Stay Days.
|
18.3 days
Interval 6.0 to 39.0
|
18.2 days
Interval 6.0 to 26.0
|
Adverse Events
Vitamins C and E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.9% Saline and Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jean-Francois Pittet, MD
UAB Department of Anesthesiology
Phone: 205-996-4755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place