InTracranial Haemorrhage
Conditions
Keywords
Factor XA Inhibitor-Related InTracranial Haemorrhage, FXa, ICH, FAITH
Brief summary
FAITH study is a multicentre retrospective analysis study that aims to understand the burden of ICH related to FXa inhibitors and the current treatment approaches in country/countries where specific reversal agents are not available yet. The results of this analysis will improve our understanding of FXa inhibitor-related ICH, its socioeconomic impact and factors associated with negative outcomes in real-world settings. The insights gained can inform clinical decision making and potentially lead to strategies to optimise the use of FXa inhibitors, increase the availability of specific reversal agents and improve patient safety and outcomes.
Detailed description
FAITH is a retrospective, non-interventional, multicentre cohort study that will retrieve the data from medical records of adult patients who were hospitalised with confirmed diagnosis of ICH while being treated with FXa inhibitors. The primary objectives of the study is to describe the characteristics and hospital outcomes of hospitalised patients with FXa inhibitors-related ICH in real-world settings. Data of consecutive patients admitted on or after 1 January 2021 and by 30 June 2023 will be retrieved. The index date is defined as the date of hospital admission.The identification of ICH will be based on the CT/MRI scan records and according to the ICD-10-CM diagnosis code. To establish the causal relation between FXa and ICH, the study will include only patients who were determined in the medical records to have taken oral FXa inhibitors.The historical data will be followed up from the index date (the date of hospital admission) until the earliest date of death, lost to follow-up or up to 6 months.The 6-month follow-up period will allow for the assessment of the disability rate and the need for supportive care among survivors.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type of discharge disposition | Hospital discharge to Maximum of 6 months | During the period from the hospital discharge date up to death event or 6 months, whichever occurs first, the following type of hospital discharge disposition will be described for survivors like Home, inpatient rehabilitation facility, nursing home, other hospitals/medical centres |
| ICH characteristics | Index day to 1 week | The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours |
| GCS score | Index day to 24hours | The GCS is scored between 3 and 15. 3 being the worst and 15 the best. It is composed of three parameters: best eye response (E), best verbal response (V), and best motor response (M) |
| mRS score | Index day to 24 hours | mRS score recorded within 24 hours on Index date The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or others causes of neurological disability. It is scored from: 0=No symptoms at all 1. No significant disability 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5=Severe disability 6=death |
| NIHSS score | Index date up to 24 hours | NIHSS score recorded within 24 hours on the Index date Scores range from 0 to 42, with higher scores indicating greater severity. Stroke severity may be stratified on the basis of NIHSS scores as follows: Very Severe: \>25 Severe: 15 - 24 Mild to Moderately Severe: 5 - 14 Mild: 1 - 5 |
| Haematoma volume | Index day to 24 hours | Haematoma volume based on baseline Imaging scans taken within 24 hours on the index date |
| Mortality at 30 days, post index event | Index date up to 30 days | Number of patients died between index date (date of hospitalization) up to 30 days |
| Mortality at 3 months post index event | Index date up to 3 months | Number of patients died between index date (date of hospitalization) up to 3 months |
| Mortality at 6 months post index event | Index date up to 6 months | Number of patients died between index date (date of hospitalization) up to 6 months |
| BP (Systolic and Diastolic) | Index day to 72 hours | BP at Index date during hospital admission and in 6, 24, and 72 hours |
| Antihypertensive treatment | Index day to 1 Week | Antihypertensive treatment patterns during hospitalisation from Index date to 1 week |
| In-hospital mortality due to any cause | Index date up to the death event during hospital stay (maximum 1 week) | Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week) |
| Patient characteristics | Index day (Date of hospitalization) to 24hours | Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization |
| Patient Characteristics | Index day (Date of hospitalization) to 24hours | Race (Middle Eastern, Asian, other) of the eligible patients is collected |
| Sociodemographic Characteristics of eligible patients | Index day (Date of hospitalization) to 24hours | Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day |
| Sociodemographic Characteristics | Index day (Date of hospitalization) to 24hours | Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day |
| Clinical characteristics | Index day (Date of hospitalization) to 24hours | Comorbidities info of the eligible patients is recorded on Index day |
| Clinical Characteristics | Index day (Date of hospitalization) to 24hours | Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day |
| FXa inhibitor characteristics | Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours | At index date the following FXa inhibitor characteristics will be described : Indication ,type and dose pf FXa Inhibitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from Hospital admission to time taken to do Imaging scan | Index day (Date of hospitalization) to Maximum of one hour | Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour |
| Time from hospital admission to administration of any haemostatic therapy | Index day (Date of hospitalization) to Maximum of one hour | Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour |
| Healthcare resource utilization during hospitalisation | Index day to maximum of 1 week | The length of ICU stay of eligible patients in days from Index day to maximum of 1 week |
| Length of hospitalisation in days | Index day to maximum of 1 week | The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week |
| Disability rate among survivors | At hospital discharge (Maximum of 1 week from Index day) | At hospital discharge (Maximum of 1 week from Index day) Modified Rankin Score (mRS) will be described Functional outcome assessed with the modified Rankin Scale (mRS) at hospital discharge .The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered of stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all 1=No significant disability, 2=Slight disability 3=Moderate disability 4=Moderately severe disability 5=Severe disability 6=death |
| Health care resource utilization after hospital admission up to 6 months | Index date to 6 months | From the index date to 6 months the following HCRU will be described: Need for supportive medical care ,type of supportive care (including rehabilitation services), inpatient rehabilitation, outpatient rehabilitation, including occupational therapists, speech and language pathologists, dietician, nurse, adaptive equipment, everything else. |
| Health care resource utilization within 6 months after hospital discharge. | Hospital discharge up to 6 months | From the patient hospital discharge up to 6 months the following HCRU will be described: Number of inpatient readmissions after discharge and up to 6 months, Type of ward, Number of days of hospitalization Reason for readmission and Medications. |
| Time from symptoms onset to hospital admission | Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours | Time between the onset of the bleeding symptoms to admission of patient in hospital in hours. |
Countries
Argentina, Brazil, Colombia, Mexico, Qatar, Saudi Arabia, United Arab Emirates
Outcome results
None listed