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Vitamin
Vitamin K for Burns (VITK Trial)
Phase 4
Waitlist Available
Led By Michael Quinn, MD
Research Sponsored by Joseph M. Still Research Foundation, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days or the study will end at time of discharge or death.
Awards & highlights
VITK Trial Summary
This trial will help determine if there are any potential complications from giving vitamin K to burn patients at a standard dose.
VITK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days or the study will end at time of discharge or death.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days or the study will end at time of discharge or death.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The for the study will be rate of DVT occurrence
Secondary outcome measures
The for this study will be comparison of coagulopathy patterns
The for this study will be total number of blood products transfused (Fresh Frozen Plasma - FFP and Packed Red Blood Cells - PRBCs.
Other outcome measures
Incidence of treatment-emergent adverse events to determine safety and tolerability
Side effects data
From 2016 Phase 3 trial • 133 Patients • NCT0146231844%
Multiple sclerosis relapse
25%
Upper respiratory tract infection
23%
Urinary tract infection
16%
Headache
14%
Nasopharyngitis
11%
Pharyngitis
11%
Back pain
10%
Influenza like illness
9%
Fatigue
9%
Pyrexia
8%
Muscular weakness
8%
Sinusitis
8%
Arthralgia
8%
Anxiety
7%
Hypoaesthesia
7%
Depression
7%
Pain in extremity
7%
Insomnia
7%
Diarrhoea
7%
Alanine aminotransferase increased
6%
Influenza
6%
Lymphadenopathy
5%
Oral herpes
5%
Muscle spasms
5%
Spinal pain
5%
Migraine
5%
Muscle spasticity
5%
Hypothyroidism
2%
Pneumonia
2%
Postmenopausal haemorrhage
1%
Sarcoidosis
1%
Autoimmune hepatitis
1%
Neutropenia
1%
Streptococcal urinary tract infection
1%
Toxicity to various agents
1%
Obesity
1%
Lumbar spinal stenosis
1%
Furuncle
1%
Hepatitis E
1%
Hepatic enzyme increased
1%
Infection
1%
Haemolytic anaemia
1%
Suicide attempt
1%
Abortion missed
1%
Hydronephrosis
1%
Endometrial hypertrophy
1%
Endometriosis
1%
Ovarian cyst
1%
Cutaneous sarcoidosis
1%
Erythema nodosum
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
DAC HYP 150 mg
VITK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Decreasing Daily Dose of Vitamin KExperimental Treatment1 Intervention
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
Group II: Standard of Care Dose of Vitamin KActive Control1 Intervention
This group of patients will be reviewed retrospectively and would have received Vitamin K IV at 10mg/day during their entire hospital course
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phylloquinone
FDA approved
Find a Location
Who is running the clinical trial?
Joseph M. Still Research Foundation, Inc.Lead Sponsor
8 Previous Clinical Trials
308 Total Patients Enrolled
2 Trials studying Burns
75 Patients Enrolled for Burns
Michael Quinn, MDPrincipal InvestigatorJoseph M. Still Research Foundation, Inc.
1 Previous Clinical Trials
65 Total Patients Enrolled
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