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

Joseph M. Still Research Foundation

Status and phase: Unknown; Phase 4

Conditions: Burns

Treatments: Drug: Vitamin K

Study type: Interventional

Funder types: Other

Identifiers

NCT03941535

JMSRF-VITK-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Decreasing Daily Dose of Vitamin K

Experimental group

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

Treatment:

Drug: Vitamin K

Standard of Care Dose of Vitamin K

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin K