atrial arrythmia
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age * 18 years - Treatment with dabigatran, rivaroxaban or apixaban (and after approval also edoxaban) - Presentation with NOAC bleeding or the need for an emergent invasive surgery or procedure within 8 hours.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be a successful clinical outcome of bleeding defined as excellent or good haemostatic efficacy. For the exact definition of excellent or good haemostatic efficacy see the table in paragraph 6.1.1 of the protocol. The primary outcome for patients who require an emergency invasive procedure, will be the occurrence of a major bleeding within 30 days follow-up. For the definition of major bleeding, see paragraph 6.1.1 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Thromboembolic complications: ischemic stroke, transient ischemic attack, myocardial infarction, DVT or PE - Bleeding complications: intracranial haemorrhage, extracranial haemorrhage, gastro-intestinal haemorrhage, all other haemorrhages - Length of stay in hospital - Admission in and length of stay in high care unit - Mortality at 30 days - Drop in haemoglobin (Hb) over 24 hours - Management of bleeding: transfusion, surgical, endoscopic or radiologic interventions to control bleeding - NOAC blood levels estimated by chromogenic anti-Xa for rivaroxaban, apixaban or edoxaban and diluted thrombin time (dTT) for dabigatran) at entry emergency department and decrease after 24 hours (in %) - Complete blood count, PT, aPTT, and other laboratory tests of interest including thrombin generation - Comparison of outcome of NOAC bleeding in the subgroup of patients treated with PCC with a historical cohort of patients treated with PCC for VKA associated bleeding. | — |
Countries
Netherlands
Outcome results
None listed