Recruiting

Vitamin K

Sponsor:

Joseph M. Still Research Foundation, Inc.

Code:

NCT03941535

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin K

Study Details

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.

Conditions

Burns

Study ID

NCT03941535

Start date

May 10, 2019

Status verified date

Aug, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Vitamin K

Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Locations

Joseph M. Still Burn Center at Doctors Hospital

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Principal Investigator:

Michael Quinn, MD

More Information

Sponsor

Joseph M. Still Research Foundation, Inc.

Last update posted

Aug 25, 2021

Last verified

Aug, 2021

Keywords

  • Vitamin K

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joseph M. Still Research Foundation, Inc. on 2021-08-25.