Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

Burns Clinical Trial

— VITK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941535
• Other study ID #: JMSRF-VITK-P01
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2019
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Joseph M. Still Research Foundation, Inc.
• Contact: Joan M Wilson, MSN, MHA, RN
• Phone: 7063642966
• Email: joan.wilson[@]jmsresearchfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center at Doctors Hospital	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Joseph M. Still Research Foundation, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fulton RL, McMurdo ME, Hill A, Abboud RJ, Arnold GP, Struthers AD, Khan F, Vermeer C, Knapen MH, Drummen NE, Witham MD. Effect of Vitamin K on Vascular Health and Physical Function in Older People with Vascular Disease--A Randomised Controlled Trial. J Nutr Health Aging. 2016 Mar;20(3):325-33. doi: 10.1007/s12603-015-0619-4. — View Citation

Vitamin K Fact Sheet for health professionals. National Institutes of Health Office of Dietary Supplements. U. S. Department of Health and Human Services. Retrieved from https://olds.od.nih.gov/factsheets/VitaminK-HealthProfessional on January 16, 2019.

Yoshida M, Jacques PF, Meigs JB, Saltzman E, Shea MK, Gundberg C, Dawson-Hughes B, Dallal G, Booth SL. Effect of vitamin K supplementation on insulin resistance in older men and women. Diabetes Care. 2008 Nov;31(11):2092-6. doi: 10.2337/dc08-1204. Epub 2008 Aug 12. — View Citation

Zittermann A. Effects of vitamin K on calcium and bone metabolism. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):483-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-emergent adverse events to determine safety and tolerability	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)
Primary	The primary outcome for the study will be rate of DVT occurrence	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	The secondary outcome for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.	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.
Secondary	The secondary outcome for this study will be comparison of coagulopathy patterns	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.