A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran. The secondary objectives are the assessment of bleeding, clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Study phase: III

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Group A-Dabigatran-treated patients seen in the Emergency Department (ED) of a hospital who exhibit signs and symptoms of (overt) uncontrolled bleeding requiring urgent medical or surgical intervention.
OR
Group B-Dabigatran treated patients seen in the Emergency Department of a hospital who require emergency surgery or other medical procedure necessitating rapid reversal of the anticoagulant effect of dabigatran prior to surgery/procedure.
AND
Establish that the patient is being treated with dabigatran.

Primary disease category: Trauma & Emergency Medicine

Sponsor: Boehringer Ingelheim

Protocol number: Version 2.0

Projected enrollment dates: April 2015 to May 2017

Official study title: A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.