Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168838
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-09-01
Brief Title:
Anticoagulant-associated Intracranial Hemorrhage
Sponsor:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Organization:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Study Overview
Official Title:
Anticoagulant-associated Intracranial Hemorrhage Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco Single-Center Observational Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAIHINNN
Brief Summary:
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 eg 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
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
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 005 for statistical significance
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 005 for statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None