Hemorrhage MedDRA version: 18.1 Level: LLT Classification code 10019524 Term: Hemorrhage System Organ Class: 100000004866
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 procedure where adequate hemostasis is required. Emergency is defined as within the next 8 hours. -- Current treatment with dabigatran -- At least 18 years of age -- Writen Informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 475
Exclusion criteria
Exclusion criteria: - 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. -- Women who are nursing or pregnant -- Patients who are legally institutionalised - 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 hypersensitiity to the drug or its excipients. -- Women who are nursing or pregnant -- Patients who are legally institutionalised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab;Secondary Objective: Evaluate safety and the pharmacokinetcs of the idarucizumab-dabigatran complex.;Primary end point(s): 1: Reversal of anticoagulant effect of dabigatran ;Timepoint(s) of evaluation of this end point: 1: up to 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Minimum unbound sum (free) dabigatran 2: Reversal of dTT or ECT after the first infusion and before the start of the second 3: Reversal of aPTT 4: Reversal of TT 5: Duration of reversal 6: Occurrence of major bleeding post-surgery (for Group B only) 7: Time to cessation of bleeding (for Group A only) ;Timepoint(s) of evaluation of this end point: 1: up to 4 hours 2: up to 15 minutes 3: up to 4 hours 4: up to 4 hours 5: up to 24 hours 6: up to 24 hours 7: up to 24 hours | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT information Disclosure
Boehringer Ingelheim GmbH & Co. KG
Outcome results
None listed