NCT03941535

Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Joseph M. Still Research Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Vitamin K	Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Timeline

• Start date: 2019-05-10
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2019-05-08
• Last updated: 2021-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study