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NCT03807856 Clinical Trial

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Acute Pancreatitis Clinical Trial

Official title:
Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03807856
Other study ID # 18-004345
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 24, 2019
Est. completion date July 23, 2020

Study information
Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date July 23, 2020
Est. primary completion date July 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Other:
• Standard of Care
Daily vital signs, lab work and one outpatient clinic visit

Locations
Country Name City State
United States Mayo clinic Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Number of Reported Adverse Events One year
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