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.

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.

Treated set (TS) comprised all patients who had been received at least 1 dose of the study medication.

From first drug administration until 5 days after last drug administration, up to 6 days.

Because of the trial design and backgrounds, only 1 patient was entered in the trial. Because of the limited number of patients, it was difficult to draw general conclusion regarding safety or tolerability of idarucizumab