CoagulopathyPhase 2NCT01897792

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

A Phase 2 study testing Vitamin C, Vitamin E and Saline (for Vitamin C) in people with Coagulopathy and Nosocomial Pneumonia, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Coagulopathy, Nosocomial Pneumonia
What is being tested?: Vitamin C, Vitamin E and Saline (for Vitamin C)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: May 2013to Feb 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294

Other trials in United States

About this study

Conditions: Coagulopathy, Nosocomial Pneumonia
Being tested: Vitamin C, Vitamin E, Saline (for Vitamin C), Placebo (for Vitamin E)
Medical subject headings: Hemostatic Disorders, Healthcare-Associated Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin CDietary supplement
Also called ascorbic acid
Vitamin EDietary supplement
Also called alpha-tocopherol
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

Study groups in NCT01897792
Study group	Role	What they receive
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. Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E
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. Receives: Dietary Supplement: Saline (for Vitamin C); Drug: Placebo (for Vitamin E)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From enrollment up to 3 days
Number of Subjects With Ventilator-associated Pneumonia.
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Measured: From enrollment to 3 days
Number of Subjects With Organ Injury
Any injury to internal organs (thoracic, abdominal or cranial cavity)
Measured: 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.
Measured: From enrollment to 3 days

Secondary outcomes (6)

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.
Measured: from enrollment up to 60 days post enrollment
Number of Subjects Surviving to Day 28
Number of subjects that survived to day 28 after enrollment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from enrollment up to 60 days post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Feb 2015

First posted12 Jul 2013 (estimated)
Study startMay 2013
Primary completionFeb 2015
Study completionFeb 2015

Why it stopped: Inability to recruit patients that meet inclusion criteria.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for CoagulopathyStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01897792
Sponsor's protocol ID: F101108001
Status last verified: Feb 2017
First submitted: 9 Jul 2013
Last updated: 29 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 17457176
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.
PubMed 18469643
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.
PubMed 19333141
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.
PubMed 20009664
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.
PubMed 12454520
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.
PubMed 18596309
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.
PubMed 20689935
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.
PubMed 12813333
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.
PubMed 12855879
Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. doi: 10.1378/chest.124.3_suppl.26s.
PubMed 12970121
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.
PubMed 20149369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coagulopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
ClinicalTrials.gov ID: NCT01897792
Acronym / sponsor ID: F101108001
Conditions: Coagulopathy, Nosocomial Pneumonia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inability to recruit patients that meet inclusion criteria.
Enrolment: 11 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: May 2013
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 12 Jul 2013 (estimated)
Results: Posted 29 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vitamins C and E	Experimental	Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin EVitamin 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	Dietary Supplement: Saline (for Vitamin C), Drug: Placebo (for Vitamin E)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.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin CAlso: ascorbic acid	Dietary supplement	Vitamins C and E
Vitamin EAlso: alpha-tocopherol	Dietary supplement	Vitamins C and E
Saline (for Vitamin C)0.9% saline administered to mimic Vitamin C	Dietary supplement	0.9% saline and sugar pill
Placebo (for Vitamin E)Sugar pill administered to mimic Vitamin E	Drug	0.9% saline and sugar pill

Primary outcome

Number of Participants With Coagulation Abnormalities
Time frame: From enrollment up to 3 days
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.
Number of Subjects With Ventilator-associated Pneumonia.
Time frame: From enrollment to 3 days
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Number of Subjects With Organ Injury
Time frame: From enrollment to 3 days
Any injury to internal organs (thoracic, abdominal or cranial cavity)
Number of Total Blood Product Transfusions
Time frame: From enrollment to 3 days
the number of blood product transfusions for all subjects in each group over the course of 3 days.

6 secondary outcomes

Number of Protocol Violations Per Arm.
Time frame: from enrollment up to 60 days post enrollment
Number of Subjects Surviving to Day 28
Time frame: from enrollment up to 28 days post enrollment
Number of Subjects With 60-day Survival
Time frame: from enrollment up to 60 days post enrollment
Mean Number of Ventilator-free Days for Subjects
Time frame: from enrollment up to 60 days post enrollment
Mean Number of Days in ICU.
Time frame: from enrollment up to 60 days post enrollment
Mean Number of Hospital Stay Days.
Time frame: from enrollment up to 60 days post enrollment

Results and safety

Results posted to the registry on 29 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamins C and E	6	6
0.9% Saline and Sugar Pill	5	5

Primary outcome: Number of Participants With Coagulation Abnormalities

Time frame: From enrollment up to 3 days. Number. Unit: participants

Measure	Vitamins C and E n = 6	0.9% Saline and Sugar Pill n = 5
Value	2	1

Primary outcome: Number of Subjects With Ventilator-associated Pneumonia.

Time frame: From enrollment to 3 days. Number. Unit: participants

Measure	Vitamins C and E n = 6	0.9% Saline and Sugar Pill n = 5
Value	4	2

Primary outcome: Number of Subjects With Organ Injury

Time frame: From enrollment to 3 days. Number. Unit: participants

Measure	Vitamins C and E n = 6	0.9% Saline and Sugar Pill n = 5
Value	0	0

Primary outcome: Number of Total Blood Product Transfusions

Time frame: From enrollment to 3 days. Number. Unit: blood transfusions

Measure	Vitamins C and E n = 6	0.9% Saline and Sugar Pill n = 5
Value	11	5

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamins C and E	0 of 0	0 of 0	Not reported
0.9% Saline and Sugar Pill	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Study terminated--inability to recruit patient that met inclusion criteria.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17457176Brohi 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.
Background: PubMed 18469643Brohi 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.
Background: PubMed 19333141Chesebro 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.
Background: PubMed 20009664Cohen 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.
Background: PubMed 12454520Nathens 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.
Background: PubMed 18596309Collier 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.
Background: PubMed 20689935Secor 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.
Background: PubMed 12813333Brohi 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.
Background: PubMed 12855879MacLeod 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.
Background: PubMed 12970121Esmon CT. The protein C pathway. Chest. 2003 Sep;124(3 Suppl):26S-32S. doi: 10.1378/chest.124.3_suppl.26s.
Background: PubMed 20149369Giladi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Francois Pittet, M.D. principal investigator

The University of Alabama at Birmingham

Jeffrey Kerby, M.D., Ph.D. principal investigator

The University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin C, Vitamin E and Saline (for Vitamin C) in people with Coagulopathy and Nosocomial Pneumonia, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Coagulation Abnormalities (time frame: From enrollment up to 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897792, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.