A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING)
- Conditions
- Bleeding
- Registration Number
- NCT06575517
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 168
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients adherent to a predefined checklist for optimal bleeding management strategies 2 months This checklist will involve proper use of blood products; proper use of reversal agents; proper dose adjusting and timing of restart of anticoagulation.
- Secondary Outcome Measures
Name Time Method