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

NCT06575517 | Withdrawn

• 1 other identifier: D9603R00021
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (2)

Group 1

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

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic use of oral anticoagulant (OAC) suffering a major bleeding event while on OAC.

You may qualify if:

• Age ≥ 18 years;

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 28, 2024
• Study Start: January 13, 2025
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.