Treating Acute Pancreatitis With Dabigatran, a Pilot Study

NCT ID: NCT03807856

Last Updated: 2022-09-01

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2020-07-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

Standard treatment for acute pancreatitis

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Daily vital signs, lab work and one outpatient clinic visit

Dabigatran Etexilate Mesylate

Dabigatran 150mg BID for 3 days

Group Type ACTIVE_COMPARATOR

Dabigatran Etexilate Mesylate

Intervention Type DRUG

Dabigatran 150mg BID for 3 days

Standard of Care

Intervention Type OTHER

Daily vital signs, lab work and one outpatient clinic visit

Interventions

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Dabigatran Etexilate Mesylate

Dabigatran 150mg BID for 3 days

Intervention Type DRUG

Standard of Care

Daily vital signs, lab work and one outpatient clinic visit

Intervention Type OTHER

Other Intervention Names

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Pradaxa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Yan Bi

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-004345

Identifier Type: -

Identifier Source: org_study_id

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