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

August 24, 2021 updated by: Joseph M. Still Research Foundation, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Joseph M. Still Burn Center at Doctors Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Quinn, MD
        • Sub-Investigator:
          • Shawn Fagan, MD
        • Sub-Investigator:
          • Bruce Friedman, MD
        • Sub-Investigator:
          • Fred Mullins, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decreasing Daily Dose of Vitamin K

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
Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day
Active Comparator: Standard of Care Dose of Vitamin K
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
Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome for the study will be rate of DVT occurrence
Time Frame: 90 days or the study will end at time of discharge or death.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.
Time Frame: 90 days or the study will end at time of discharge or death.
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
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
Time Frame: 90 days or the study will end at time of discharge or death.
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).
90 days or the study will end at time of discharge or death.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events to determine safety and tolerability
Time Frame: from time consent is signed throughout the duration of active study participation (90 days, discharge or death - whichever comes first)
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.
from time consent is signed throughout the duration of active study participation (90 days, discharge or death - whichever comes first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph M. Still Research Foundation, Inc.

Investigators

  • Principal Investigator: Michael Quinn, MD, Joseph M. Still Research Foundation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMSRF-VITK-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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