An observational study in Bleeding, sponsored by AstraZeneca. Withdrawn. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by AstraZeneca · Observational
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.
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Patients with chronic use of oral anticoagulant (OAC) suffering a major bleeding event while on OAC.
Inclusion criteria
The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding.
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.
Proportion of patients adherent to a predefined checklist for optimal bleeding management strategies
This checklist will involve proper use of blood products; proper use of reversal agents; proper dose adjusting and timing of restart of anticoagulation.
Time frame: 2 months
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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