The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Intravenous
Beijing AnZhen Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Cardiovascular Institute and Fu Wai Hospital
Beijing, China
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 41.26 seconds.
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 35.54 seconds.
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
Time frame: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery
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First Affiliated Hospital of Dalian Medical University
Dalian, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Guangzhou, China
2nd Affiliated Hosp Zhejiang University College of Medical
Hangzhou, China
Zhejiang Province People's Hospital
Hangzhou, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, Jiangsu Province, China
...and 3 more locations
Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported.
Time frame: Up to 24 hours post-surgery.
Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported.
Time frame: Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is \> 100, it was set to 100. 100% ULN is 39.80 seconds.
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)
Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is \> 100, it was set to 100. 100% ULN is 14.22 seconds.
Time frame: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
Numbers of Participants With Any Adverse Events - on Treatment
Numbers of participants with any adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Numbers of participants with any adverse events until end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Serious Adverse Events - on Treatment
Number of participants with Serious adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Serious Adverse Events - Including Post Treatment Period
Number of participants with Serious adverse events until the end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Drug-related Adverse Events - on Treatment
Numbers of patients with drug-related adverse events during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Numbers of patients with drug-related adverse events until end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Immune Reaction Adverse Event - on Treatment
Number of participants with immune reaction adverse event during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Number of participants with immune reaction adverse event until end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
Number of Participants With Thrombotic Events - on Treatment
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
Time frame: Since the first infusion up until 5 days after the completion of the second infusion.
Number of Participants With Thrombotic Events - Including Post Treatment Period
Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
Time frame: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.