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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
503
idarucizumab
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
Time frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1
Reversal of aPTT and TT From Central Laboratory
Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
Time frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1
Duration of Reversal
Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
Time frame: from the first infusion up to 24 hours after the last infusion on Day 1
Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively
Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH \[International Society for Thrombosis and Hemostasis\] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
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Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
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
...and 166 more locations
Time frame: within 24 hours of surgery
Time to Cessation of Bleeding (for Group A Only)
Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
Time frame: from the first infusion up to 24 hours after the last infusion on Day 1
Cmin,1 of Unbound Sum (Free) Dabigatran
Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
Time frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial
Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial
Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
Time frame: after the first vial of idarucizumab and before the start of second vial on Day1