Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph M. Still Research Foundation, Inc.
• Treatments: Vitamin K; Vitamins

Criteria

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.