Anticoagulant-associated Intracranial Hemorrhage (AAIHINNN)

December 12, 2023 updated by: Vanessa Cano, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study

Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events.

Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients.

There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation.

These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk.

Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events.

This information can be used to improve patient outcomes and guide future research.

Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study observational. The total number of subjects for this study will be determined by the number of patients with intracranial bleeding associated with anticoagulant therapy on the clinical records.

Primary objective: To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.

Secondary objective:

  • To identify mortality related to intracranial bleeding associated with oral anticoagulant therapy, including vitamin K antagonists, factor Xa inhibitors and factor 2a inhibitors.
  • To identify patients´ characteristics correlated with intracranial hemorrhage associated with oral anticoagulants.
  • To identify treatment patterns: anticoagulant-associated intracranial bleeding management, including clinical, pharmacological, surgical, and interventional treatments, as well as procoagulant therapies.

Sample size Justification / Statistical Analysis: Non probabilistic, incidental reasoned selection.

The sample size will be determined by the number of patients with intracranial hemorrhage associated with anticoagulation in the clinical records. All electronic medical records that meet the inclusion criteria will be included in the analysis.

Descriptive analysis:

Descriptive statistics will be used for demographic and clinical characteristics of the study sample. This will include measures of central tendency (mean, median) and measures of dispersion (standard deviation, range).

Analytic (Inferential) analysis:

A univariate analysis will take place in order to examine the relationship between demographic and clinical variables with anticoagulation-associated intracranial hemorrhage This will include chi-squared tests for categorical data and T-tests or Mann-Whitney U Tests for continuous data.

A multivariable logistic regression analysis will be done to identify independent predictors of intracranial bleeding associated with anticoagulant therapy. The variables to include in the model will be determined by de univariate analysis results.

The investigators will consider a p-value under 0.05 for statistical significance.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 14269
        • Recruiting
        • Instituto Nacional de Neurologia y Neurocirugia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All outpatients and/or hospitalized patients and patients from the emergency room of the National Institute of Neurology and Neurosurgery Manuel Velasco Suárez with intracranial hemorrhage diagnosis under anticoagulant therapy such as Vitamin K antangonists, Factor Xa inhibitors or direct thrombin inhibitors.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Know incidence and prevalence of intracranial bleeding events
Time Frame: From January 2015 to November 2023
To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.
From January 2015 to November 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Collaborators

AstraZeneca

Investigators

  • Study Director: Claudia Vanessa Cano Nigenda, MD, Instituto Nacional de Neurología y Neurocirugía. Manuel Velasco Suárez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INNN-DI-CI-271-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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