Health Condition 1: null- In patients treated with dabigatran etexilate (Pradaxa) who have uncontrolled bleeding or require emergency surgery or procedures.
Conditions
Interventions
Intervention1: Idarucizumab (BI 655075): Idarucizumab is a humanized monoclonal antibody fragment (Fab), administered as an intravenous infusion. The drug product (50mg/ml) is formulated as a buffered
Sponsors
Boehringer Ingelheim
Eligibility
Inclusion criteria
Inclusion criteria: Patients taking dabigatran are eligible for this study if they meet the following criteria: Group A: 1. Overt bleeding judged by the physician to require a reversal agent. 2. Currently taking dabigatran etexilate. 3. Age >= 18 years at entry. 4. Written Informed consent. Group B: 1. A condition requiring emergency surgery or procedure where adequate hemostasis is required. Emergency is defined as within the next 4 hours. 2. Currently taking dabigatran etexilate. 3. Age >= 18 years at entry. 4. Written Informed consent.
Exclusion criteria
Exclusion criteria: Group A: 1. Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care. 2. Patients with no clinical signs of bleeding. 3. Contraindications to study medication including known hypersensitivity to the drug or its excipients. Group B: 1. A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low. 2. Contraindications to study medication including known hypersensitivity to the drug or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to measure the reversal of anticoagulant effect of dabigatran based on central laboratory determination of dTT or ECT.Timepoint: An interim analysis is planned after recruitment of 10-25 patients (globally) to demonstrate reversibility of anticoagulant effect of Dabigatran. We anticipate approximately 3 years will be required to recruit target number of 250-300 patients. The final analysis will be planned after recruitment of target number of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality - Number of days hospitalized in ICU For ICH patients with serial CT scans, an estimate of blood volume - Fro Gp. A patients: Use of blood products after administration of study drug (includes FFP, packed RBCs, platelets, volume expanders, tranexamic acid, cryoprecipitate, Factor VIIa and any other hemostatic agents. Use of dialysis, change from baseline in haematocrit, Hb. Gp. B patients: Occurrence of bleeding. Bleeding will be categorized by the treating clinician.Timepoint: These analyses of the secondary outcome will be available during Interim analysis (planned after recruitment of 10-25 patients) and after final data base lock. | — |
Countries
Argentina, Australia, Belgium, Canada, China, Germany, Hong Kong, India, Poland, Portugal, Sweden, Switzerland, United Kingdom, United States of America
Contacts
Public ContactPartha Gokhale
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed