Acute Pancreatitis
Conditions
Brief summary
Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.
Detailed description
Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.
Interventions
Dabigatran 150mg BID for 3 days
OTHERStandard of Care
Daily vital signs, lab work and one outpatient clinic visit
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase \>3 times UNL and AP on images) * 18-75 years old * Willingness to sign the informed consent * Symptom onset within 72 hours
Exclusion criteria
* Under 18 years of age or over 75 years of age * Pregnancy or lactating * Presence of pseudo aneurysm on CT * Predicted severe acute pancreatitis * Unwilling or unable to sign the informed consent * Had recent surgery or sphincterotomy * Active pathological bleeding * Concurrent use of anti-coagulation * Known serious hypersensitivity reaction to Dabigatran * CrCI \<30mL/min or on dialysis * Mechanical prosthetic valves * Liver disease * Cancer * On Chemotherapy or immunosuppressant * Persistent ALT, AST, Akl Phos \>2 x ULN * Active hepatitis C, active hepatitis B, and active hepatitis A * Anemia (hemoglobin \<10g/dL) * Thrombocytopenia * Concomitant use of P-gp inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | One year | Number of Reported Adverse Events |
Countries
United States
Outcome results
None listed