Status:
TERMINATED
Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Lead Sponsor:
Mayo Clinic
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03807856
Start Date
June 24 2019
End Date
July 23 2020
Last Update
September 1 2022
Active Locations (1)
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1
Mayo clinic
Jacksonville, Florida, United States, 32224