Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

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 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.

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.

- 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).