Hemorrhage
Conditions
Brief summary
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.
Interventions
DRUGidarucizumab
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently taking dabigatran etexilate. * Age \>= 20 years at entry. * Written Informed consent * Group A: \-- Uncontrolled or life-threatening judged by the physician to require a reversal agent. * Group B: * A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Exclusion criteria
* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol). * Group A: * Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care. * Patients with no clinical signs of bleeding. * Group B: * surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events | from first drug administration until 5 days after last drug administration, up to 6 days. | Percentage of subjects with drug-related adverse events is presented |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Idarucizumab 5 g The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Idarucizumab 5 g |
|---|---|
| Age, Continuous | 82 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events is presented
Time frame: from first drug administration until 5 days after last drug administration, up to 6 days.
Population: Treated Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idarucizumab 5 g | Percentage of Subjects With Drug-related Adverse Events | 0.0 Percentage of participants |