Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Completed · Phase 3

Conditions studied: Hemorrhage

In brief

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Key facts

Study ID

NCT02104947

Run by

Boehringer Ingelheim

People needed

503

Starts

2014-05-06

Expected to finish

2016-10-20

Last updated by the study team

2018-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Group A (Bleeding patients)
• Overt bleeding judged by the physician to require a reversal agent
• Currently taking dabigatran etexilate
• At least 18 years of age
• Written informed consent
• Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding
• Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
• Current treatment with dabigatran
• At least 18 years of age
• Written Informed consent.

You may not qualify if…

• Group A (Bleeding Patients)
• Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
• Patients with no clinical signs of bleeding
• Contraindications to study medication including known hypersensitivity to the drug or its excipients.
• Group B (Patients who require emergency surgery or procedure)
• A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
• Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Mayo Clinic Cancer Center — Jacksonville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Community Hospital — Munster, Indiana, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Henry Ford Allegiance Health — Jackson, Michigan, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• St. Elizabeth Youngstown Hospital — Youngstown, Ohio, United States
• St. John Health System Inc — Tulsa, Oklahoma, United States
• St. Mary Medical Center — Langhorne, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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