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

NCT ID: NCT06575517

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-01-13

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.

Conditions

Bleeding

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding.

No interventions assigned to this group

Group 2

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years;

Exclusion Criteria

• Patients with limitation to follow-up;
• Patients with do not resuscitate order at time of enrolment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

D9603R00021

Identifier Type: -

Identifier Source: org_study_id