Investigating bleeding in patients using anticoagulants
Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez · NCT06168838
This study looks at how often people on blood thinners experience bleeding in the brain and what factors might be linked to these events.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (other) |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06168838 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence and prevalence of intracranial bleeding events associated with oral anticoagulant therapy, including vitamin K antagonists and factor Xa and 2a inhibitors. It will analyze clinical records of patients diagnosed with intracranial hemorrhage while on anticoagulant therapy from January 2015 to July 2023. The study will also explore mortality rates related to these bleeding events and identify patient characteristics and treatment patterns associated with anticoagulant-related intracranial hemorrhages.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have been diagnosed with intracranial hemorrhage while receiving oral anticoagulant therapy.
Not a fit: Patients without available clinical records or those who did not complete follow-up after an intracranial bleeding event may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of the risks associated with anticoagulant therapy, potentially leading to better management strategies for patients at risk of intracranial bleeding.
How similar studies have performed: Other studies have shown success in understanding the risks of anticoagulant therapy, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Intracranial hemorrhage diagnosis and concomitant oral anticoagulant therapy * Available clinical record from January 2015 to July 2023 Exclusion Criteria: * Non available clinical record * Patients that did not complete follow up on days 30 and 90 after an intracranial bleeding.
Where this trial is running
Mexico City
- Instituto Nacional de Neurología y Neurocirugía — Mexico City, Mexico (RECRUITING)
Study contacts
- Study coordinator: Andrés Alberto Mercado Pompa, MD
- Email: clinica-evc@innn.edu.mx
- Phone: +525556063822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anticoagulant-induced Bleeding, Intracranial Hemorrhages, Anticoagulants, Intracranial hemorrhage