Treating Acute Pancreatitis With Dabigatran, a Pilot Study
NCT ID: NCT03807856
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2019-06-24
2020-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Standard treatment for acute pancreatitis
Standard of Care
Daily vital signs, lab work and one outpatient clinic visit
Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Standard of Care
Daily vital signs, lab work and one outpatient clinic visit
Interventions
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Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Standard of Care
Daily vital signs, lab work and one outpatient clinic visit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-75 years old
* Willingness to sign the informed consent
* Symptom onset within 72 hours
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Yan Bi
Principal Investigator
Principal Investigators
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Yan Bi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo clinic
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-004345
Identifier Type: -
Identifier Source: org_study_id
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