Clinical trial NCT03941535: Comparison of Vitamin K Doses in Patients With Larger Burn Injuries
Official title: Comparison of a Decreasing Dose of Daily Intravenous Vitamin K to a Single Dose Given as Standard of Care to an Historical Cohort in Subjects With Larger Burns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Burns
Keywords: Vitamin K
Lead sponsor: Joseph M. Still Research Foundation, Inc.
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective interventional study to compare a decreasing dose of daily Vitamin K to a matched retrospective cohort
Primary purpose: TREATMENT

Brief summary: The use of Vitamin K in treating bleeding diatheses is well documented and accepted as standard of care, as is the effect of Vitamin K on calcium and bone metabolism. In the treatment of larger burns however, there is a paucity of available literature related to optimal daily dosing, goals of therapy and potential complications. This study aims to identify any potential issues arising from the administration of a standard of care dose in an historical cohort of subjects with larger burns to a prospective patient population given a decreasing dose during their intensive care unit (ICU) stay.

Detailed description: This will be a prospective, single-center study. Eligible subjects will present with a minimum 20% Total Body Surface Area (TBSA) burn injury and expected to receive the standard dose of intravenous Vitamin K (10mg/day). Exclusion criteria will include any patient admitted with a history of, or having present at baseline: bleeding disorders, thrombocytopenia, coagulopathy, or liver dysfunction (MELD Score ≥20). Subjects who are moribund, or in the opinion of the investigator, not expected to survive will be excluded, as well as burns induced as a result of a suicide attempt.

The study will enroll approximately 25 subjects in the prospective arm and 25 subjects will be matched from our medical record data base to the basic subject criteria for the chart review portion of the study. Study duration will be 90 days.

The research foundation will request exemption, waiver of HIPAA (Health Insurance Portability and Accountability Act) authorization and waiver of informed consent for the data collection /cohort portion of the study as only burn injury demographics, lab results and dosing regimen will be collected. No protected health information (PHI) will be recorded on patients identified for the cohort arm of the study.

Eligibility criteria: Inclusion Criteria:

* The Subject:

  1. is anticipated to be hospitalized for the duration of treatment.
  2. is ≥18 years of age.
  3. or their legally authorized representative is able to provide informed consent.
  4. has been diagnosed with at least 20%TBSA thermal, chemical, or electrical burn.
  5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)?
  6. is expected to receive the standard of care dosing of intravenous Vitamin K (10g/day).

Exclusion Criteria:

* The Subject:

  1. has a history or, or has present at baseline any of the following:

     1. bleeding disorders
     2. thrombocytopenia
     3. coagulopathy
  2. liver failure (MELD -Model for end stage liver disease score ≥20)
  3. is already therapeutically anticoagulated for PE, DVT, etc.
  4. is participating in another interventional clinical trial for the duration of the study.
  5. is moribund, or in the opinion of the investigator is not expected to survive.
  6. has a burn injury sustained as a result a suicide attempt.

Historical Cohort Inclusion/Exclusion All criteria will be the same except there will be no informed consent requirement. The data collection portion in the historical cohort will be to match burn size, type and etiologies and to collect lab results and other outcomes as specified in the study objectives. No PHI will be collected or shared. Additionally, only patients that received intravenous Vitamin K 10m/day for at least 14 days will be chosen for data collection. Every attempt will be made to match study drug duration (90days) as closely as possible.

Primary outcomes:
measure: The primary outcome for the study will be rate of DVT occurrence
timeFrame: 90 days or the study will end at time of discharge or death.
Secondary outcomes:
measure: The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.
timeFrame: 90 days or the study will end at time of discharge or death.
measure: The secondary outcome for this study will be comparison of coagulopathy patterns
timeFrame: 90 days or the study will end at time of discharge or death.
Other outcomes:
measure: Incidence of treatment-emergent adverse events to determine safety and tolerability
timeFrame: from time consent is signed throughout the duration of active study participation (90 days, discharge or death - whichever comes first)
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Burn Center at Doctors Hospital
state: Georgia
Study officials:
affiliation: Joseph M. Still Research Foundation, Inc.
name: Michael Quinn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zittermann A. Effects of vitamin K on calcium and bone metabolism. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):483-7. doi: 10.1097/00075197-200111000-00003.
citation: Fulton RL, McMurdo ME, Hill A, Abboud RJ, Arnold GP, Struthers AD, Khan F, Vermeer C, Knapen MH, Drummen NE, Witham MD. Effect of Vitamin K on Vascular Health and Physical Function in Older People with Vascular Disease--A Randomised Controlled Trial. J Nutr Health Aging. 2016 Mar;20(3):325-33. doi: 10.1007/s12603-015-0619-4.
citation: Yoshida M, Jacques PF, Meigs JB, Saltzman E, Shea MK, Gundberg C, Dawson-Hughes B, Dallal G, Booth SL. Effect of vitamin K supplementation on insulin resistance in older men and women. Diabetes Care. 2008 Nov;31(11):2092-6. doi: 10.2337/dc08-1204. Epub 2008 Aug 12.
citation: Vitamin K Fact Sheet for health professionals. National Institutes of Health Office of Dietary Supplements. U. S. Department of Health and Human Services. Retrieved from https://olds.od.nih.gov/factsheets/VitaminK-HealthProfessional on January 16, 2019.