Prospective registry of management and outcome of bleeding complications in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs)

Completed

• Conditions: atrial arrythmia; deep vein thrombosis; atrial fibrillation; pulmonary embolism; 10007521; 10014523

• Registration Number: NL-OMON44969
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- Age * 18 years
- Treatment with dabigatran, rivaroxaban or apixaban (and after approval also edoxaban)
- Presentation with NOAC bleeding or the need for an emergent invasive surgery or procedure within 8 hours.

Exclusion Criteria

None

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome variable will be a successful clinical outcome of bleeding<br /><br>defined as excellent or good haemostatic efficacy. For the exact definition of<br /><br>excellent or good haemostatic efficacy see the table in paragraph 6.1.1 of the<br /><br>protocol.<br /><br><br /><br>The primary outcome for patients who require an emergency invasive procedure,<br /><br>will be the occurrence of a major bleeding within 30 days follow-up. For the<br /><br>definition of major bleeding, see paragraph 6.1.1 of the protocol.</p><br>