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Trial record 3 of 3 for:    "Acute Pancreatitis" | "Serine"

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

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ClinicalTrials.gov Identifier: NCT03807856
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Bi, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Dabigatran Etexilate Mesylate Other: Standard of Care Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Acute Pancreatitis With Dabigatran, a Pilot Study
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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 Name: 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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: One year ]
    Number of Reported Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807856


Contacts
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Contact: Yan Bi, MD 9049536970 bi.yan@mayo.edu

Locations
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United States, Florida
Mayo clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Yan Bi    904-953-6970    bi.yan@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Yan Bi, MD, PhD Mayo Clinic

Additional Information:
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Responsible Party: Yan Bi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03807856     History of Changes
Other Study ID Numbers: 18-004345
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants