Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Mayo Clinic

Status and phase: Terminated; Phase 1

Conditions: Acute Pancreatitis

Treatments: Other: Standard of Care; Drug: Dabigatran Etexilate Mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT03807856

18-004345

Details and patient eligibility

About

Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Dabigatran Etexilate Mesylate

Active Comparator group

Description:

Dabigatran 150mg BID for 3 days

Treatment:

Drug: Dabigatran Etexilate Mesylate

Other: Standard of Care

Standard of Care

Active Comparator group

Description:

Standard treatment for acute pancreatitis

Treatment:

Other: Standard of Care