A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING)

A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING): a Cluster-randomized Trial

Prospective, cluster randomized trial including expected 168 patients with chronic use of oral anticoagulation (OAC) suffering major bleeding. Randomization will be performed stratified by geographic region (Southern/Southeastern Brazil versus other Brazilian regions).

The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding, including transfusion thresholds and when indicated; laboratory assessment of coagulation when indicated; reversal agents when indicated, and tailored approach to restarting of oral anticoagulation and dosing adjustments among patients after bleeding episode. This bundle will be based on a society guideline on bleeding management from the American College of Cardiology. The Group 2 will be randomized to the standard of care. Standard of care will be left to the discretion of the sites (clusters) participating in the study. All sites, including those from the control group, will be encouraged to follow local policies of blood product utilization and bleeding management.

Inclusion criteria

• Age ≥ 18 years;
• Patients using chronic OAC (that is, for 30 or more consecutive days) due to AF/flutter, VTE or other clinical indication and presenting with a major bleeding episode according to the definition of the International Society of Thrombosis and Hemostasis (ISTH). Exclusion criteria
• Patients with limitation to follow-up;
• Patients with do not resuscitate order at time of enrolment.