Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
* Current treatment with dabigatran
* At least 18 years of age
* Written Informed consent.
You may not be if
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.
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 hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
