Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

NCT03941535 | Unknown Phase 4 FDA Drug

• 1 other identifier: JMSRF-VITK-P01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Vitamin K

Outcome Measures

Primary Outcomes (1)

• The primary outcome for the study will be rate of DVT occurrence

  This outcome will be measured in patients with larger burn % total body surface area (TBSA) burn injury receiving Vitamin K 10mg/day with a decreasing dose over 5 days and maintaining a lower daily dose, versus an historical cohort that received intravenous Vitamin K 10m/day during their entire intensive care unit (ICU) stay.

  90 days or the study will end at time of discharge or death.

Secondary Outcomes (2)

• The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.

  90 days or the study will end at time of discharge or death.

• The secondary outcome for this study will be comparison of coagulopathy patterns

  90 days or the study will end at time of discharge or death.

Other Outcomes (1)

• Incidence of treatment-emergent adverse events to determine safety and tolerability

  from time consent is signed throughout the duration of active study participation (90 days, discharge or death - whichever comes first)

Study Arms (2)

Decreasing Daily Dose of Vitamin K

EXPERIMENTAL

This group of patients will receive a decreasing dose of Vitamin K IV: Days 1-2 = 10mg/day (standard of care) Days 3-4 = 5mg/day Days 5-90 (or date of discharge, death, etc) = 2mg/day

Drug: Vitamin K

Standard of Care Dose of Vitamin K

ACTIVE COMPARATOR

This group of patients will be reviewed retrospectively and would have received Vitamin K IV at 10mg/day during their entire hospital course

Drug: Vitamin K

Interventions

Vitamin K DRUG

Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Decreasing Daily Dose of Vitamin K; Standard of Care Dose of Vitamin K

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The Subject:
• has a history or, or has present at baseline any of the following:
• bleeding disorders
• thrombocytopenia
• coagulopathy
• liver failure (MELD -Model for end stage liver disease score ≥20)
• is already therapeutically anticoagulated for PE, DVT, etc.
• is participating in another interventional clinical trial for the duration of the study.
• is moribund, or in the opinion of the investigator is not expected to survive.
• has a burn injury sustained as a result a suicide attempt.

Sponsors & Collaborators

• Joseph M. Still Research Foundation, Inc.: lead

Study Sites (1)

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 11706280 BACKGROUND

• 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.

  PMID: 26892582 BACKGROUND

• 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.

  PMID: 18697901 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Study Officials

• Michael Quinn, MD

  Joseph M. Still Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan M Wilson, MSN, MHA, RN

CONTACT

7063642966; joan.wilson@jmsresearchfoundation.org

Tammy Taylor

CONTACT

7063642966; tammy.taylor@jmsresearchfoundation.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective interventional study to compare a decreasing dose of daily Vitamin K to a matched retrospective cohort

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 8, 2019
• Study Start: May 10, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)