search
Back to results

Comparison of Vitamin K Doses in Patients With Larger Burn Injuries (VITK)

Primary Purpose

Burns

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin K
Sponsored by
Joseph M. Still Research Foundation, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Vitamin K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Joseph M. Still Burn Center at Doctors HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decreasing Daily Dose of Vitamin K

Standard of Care Dose of Vitamin K

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.
This outcome will be measured in patients with larger burn % TBSA 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 ICU stay
The secondary outcome for this study will be comparison of coagulopathy patterns
This outcome will be measured in patients with larger burn % TBSA 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 ICU stay as evidenced by changes in: (Protime - PT, Partial Thromboplastin Time - PTT and International Normalized Ration - INR, liver function abnormalities (Serum glutamic pyruvic transaminase - SGPT, Serum glutamic oxaloacetic transaminase - SGOT, Albumin , Bilirubin).

Full Information

First Posted
April 22, 2019
Last Updated
August 24, 2021
Sponsor
Joseph M. Still Research Foundation, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03941535
Brief Title
Comparison of Vitamin K Doses in Patients With Larger Burn Injuries
Acronym
VITK
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joseph M. Still Research Foundation, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Vitamin K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective interventional study to compare a decreasing dose of daily Vitamin K to a matched retrospective cohort
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decreasing Daily Dose of Vitamin K
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care Dose of Vitamin K
Arm Type
Active Comparator
Arm Description
This group of patients will be reviewed retrospectively and would have received Vitamin K IV at 10mg/day during their entire hospital course
Intervention Type
Drug
Intervention Name(s)
Vitamin K
Intervention Description
Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day
Primary Outcome Measure Information:
Title
The primary outcome for the study will be rate of DVT occurrence
Description
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.
Time Frame
90 days or the study will end at time of discharge or death.
Secondary Outcome Measure Information:
Title
The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.
Description
This outcome will be measured in patients with larger burn % TBSA 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 ICU stay
Time Frame
90 days or the study will end at time of discharge or death.
Title
The secondary outcome for this study will be comparison of coagulopathy patterns
Description
This outcome will be measured in patients with larger burn % TBSA 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 ICU stay as evidenced by changes in: (Protime - PT, Partial Thromboplastin Time - PTT and International Normalized Ration - INR, liver function abnormalities (Serum glutamic pyruvic transaminase - SGPT, Serum glutamic oxaloacetic transaminase - SGOT, Albumin , Bilirubin).
Time Frame
90 days or the study will end at time of discharge or death.
Other Pre-specified Outcome Measures:
Title
Incidence of treatment-emergent adverse events to determine safety and tolerability
Description
This outcome will be measured in patients with larger burn % TBSA 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 ICU stay.
Time Frame
from time consent is signed throughout the duration of active study participation (90 days, discharge or death - whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan M Wilson, MSN, MHA, RN
Phone
7063642966
Ext
7505
Email
joan.wilson@jmsresearchfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Taylor
Phone
7063642966
Ext
7501
Email
tammy.taylor@jmsresearchfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Quinn, MD
Organizational Affiliation
Joseph M. Still Research Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph M. Still Burn Center at Doctors Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Wilson
Phone
706-364-2966
Ext
7063642966
Email
joan.wilson@jmsresearchfoundation.org
First Name & Middle Initial & Last Name & Degree
Tammy Taylor
Phone
7063642966
Ext
7063642966
Email
tammy.taylor@jmsresearchfoundation.org
First Name & Middle Initial & Last Name & Degree
Michael Quinn, MD
First Name & Middle Initial & Last Name & Degree
Shawn Fagan, MD
First Name & Middle Initial & Last Name & Degree
Bruce Friedman, MD
First Name & Middle Initial & Last Name & Degree
Fred Mullins, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11706280
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.
Results Reference
background
PubMed Identifier
26892582
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.
Results Reference
background
PubMed Identifier
18697901
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.
Results Reference
background
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.
Results Reference
background

Learn more about this trial

Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

We'll reach out to this number within 24 hrs