Treating Acute Pancreatitis With Dabigatran, a Pilot Study

August 30, 2022 updated by: Yan Bi, Mayo Clinic
Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Drug: Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
Other Names:
  • Pradaxa
Other: Standard of Care
Daily vital signs, lab work and one outpatient clinic visit
Active Comparator: Standard of Care
Standard treatment for acute pancreatitis
Other: Standard of Care
Daily vital signs, lab work and one outpatient clinic visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: One year
Number of Reported Adverse Events
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Yan Bi, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Actual)

July 23, 2020

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-004345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Pancreatitis

Clinical Trials on Dabigatran Etexilate Mesylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe