FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

Launched by ASTRAZENECA · May 16, 2024

Keywords

ClinConnect Summary

The FAITH study is looking at how certain blood-thinning medications, known as Factor Xa inhibitors, can lead to a type of bleeding in the brain called intracranial hemorrhage (ICH). This study is important because it aims to understand how common these cases are, especially in places where specific treatments to reverse the effects of these medications are not available. By analyzing data from patients who experienced ICH, researchers hope to learn more about the impact of these medications on patients' health and safety, which could help doctors make better treatment decisions in the future.

To be eligible for this study, participants must be adults aged 18 and older who were admitted to the hospital with a bleeding issue in the brain, confirmed by imaging tests like CT or MRI scans. They should have taken a dose of Factor Xa inhibitors within the 24 hours before their hospital visit. However, individuals treated with a specific reversal agent called andexanet alfa or those involved in other clinical trials during this time cannot participate. Participants in the study can expect their medical records to be reviewed to gather information about their condition and treatment, with the goal of improving patient safety and outcomes for those affected by similar issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women ≥ 18 years of age at the time of hospital admission.
• • Patients presented with a spontaneous or traumatic haemorrhage into any intracranial compartment. The diagnosis of ICH will be based on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan and according to the ICD-10-CM diagnosis code.
• • Patients who were determined in the medical records to have taken a dose of oral FXa inhibitors within 24 hrs before hospital presentation that warranted reversal of anticoagulant activities.
• Exclusion Criteria:
• • Patients who were treated with andexanet alfa.
• • Patients who were enrolled in any clinical trials during the study period.