Reversal Dabigatran Anticoagulant Effect With Idarucizumab
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: Idarucizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The trial objective is to demonstrate the safety of idarucizumab, as assessed by the
      occurence of patients with drug related adverse events (including immune reactions) and
      all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in
      ongoing clinical trials who require emergency surgery/urgent procedures or patients who have
      life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid
      reversal of the anticoagulant effect of dabigatran is needed.
    

Eligibility criteria:

        Inclusion criteria:

        Patients taking dabigatran etexilate in the paediatric trials 1160.106 or 1160.108 are
        eligible for this trial if they meet the following criteria:

        Group A:

          -  Overt bleeding judged by the treating physician to require a reversal agent.

          -  Currently taking dabigatran etexilate in the context of a clinical trial with
             dabigatran etexilate (1160.106 or 1160.108).

          -  Male or female patients from 0 to less than 18 years of age at the time of informed
             consent/assent for participation in trial 1160.106 or in trial 1160.108.

          -  Female patients of childbearing potential (defined as having experienced menarche)
             must have followed the contraception requirements according to the dabigatran trial
             1160.106 or trial 1160.108 in which they are enrolled.

          -  Written informed consent provided by the patient (and/or the patient's legally
             accepted representative) and assent provided by the patient (if applicable) at the
             time of informed consent signature in accordance with Good Clinical Practice (GCP) and
             local legislation prior to admission to the trial. If the child is unable to give
             assent at the time of the emergency, the assent, when applicable will be obtained as
             soon as feasible.

        Group B:

          -  A condition requiring an emergency surgery or invasive procedure where adequate
             haemostasis is required. Emergency is defined as need for surgery or intervention
             within the following 8 hours.

          -  Currently taking dabigatran etexilate in the context of a clinical trial with
             dabigatran etexilate (1160.106 or 1160.108).

          -  Male or female patients from 0 to less than 18 years of age at the time of informed
             consent/assent for participation in trial 1160.106 or in trial 1160.108.

          -  Female patients of childbearing potential (defined as having experienced menarche)
             must have followed the contraception requirements according to the dabigatran trial
             1160.106 or trial 1160.108 in which they are enrolled.

          -  Written informed consent provided by the patient (and/or the patient's legally
             accepted representative) and assent provided by the patient (if applicable) at the
             time of informed consent signature in accordance with GCP and local legislation prior
             to admission to the trial. If the child is unable to give assent at the time of the
             emergency, the assent, when applicable will be obtained as soon as feasible.

        Exclusion criteria:

        Group A:

          -  Patients with minor bleeding (e.g. epistaxis, haematuria) who can be managed with
             standard supportive care.

          -  Patients with no clinical signs of bleeding.

          -  Patients with body weight < 2.5 kg

          -  Contraindications to trial medication including known hypersensitivity to the drug or
             its excipients; i.e. patients with hereditary fructose intolerance who may react to
             sorbitol.

          -  Female patients who are pregnant, nursing, or who plan to become pregnant while in the
             trial.

        Group B:

          -  A surgery or procedure which is elective or where the risk of uncontrolled or
             unmanageable bleeding is low.

          -  Patients with body weight < 2.5 kg

          -  Contraindications to trial medication including known hypersensitivity to the drug or
             its excipients; i.e. patients with hereditary fructose intolerance who may react to
             sorbitol.

          -  Female patients who are pregnant, nursing, or who plan to become pregnant while in the
             trial.