FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization

Race (Middle Eastern, Asian, other) of the eligible patients is collected

Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day

Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day

Comorbidities info of the eligible patients is recorded on Index day

Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day

At index date the following FXa inhibitor characteristics will be described :

Indication ,type and dose pf FXa Inhibitor

The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date 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 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

• No significant disability
• Slight disability
• Moderate disability
• Moderately severe disability 5=Severe disability

6=death

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 based on baseline Imaging scans taken within 24 hours on the index date

BP at Index date during hospital admission and in 6, 24, and 72 hours

Antihypertensive treatment patterns during hospitalisation from Index date to 1 week

Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week)

Number of patients died between index date (date of hospitalization) up to 30 days

Number of patients died between index date (date of hospitalization) up to 3 months

Number of patients died between index date (date of hospitalization) up to 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

Time between the onset of the bleeding symptoms to admission of patient in hospital in hours.

Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour

Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour

The length of ICU stay of eligible patients in days from Index day to maximum of 1 week

The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week

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

At three months, after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.

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.

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.

At six months after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.