FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage

InTracranial Haemorrhage Clinical Trial

— FAITH  

Official title:

A Real-World, Observational, Multicentre Retrospective Analysis to Evaluate the Clinical Characteristics, Medical Management and Outcomes of Hospitalised Patients With Factor XA Inhibitor-Related InTracranial Haemorrhage (FAITH)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420011
• Other study ID #: D9603R00022
• Status: Not yet recruiting
• Start date: July 3, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• InTracranial Haemorrhage
• Intracranial Hemorrhages

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics	Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization	Index day (Date of hospitalization) to 24hours
Primary	Patient Characteristics	Race (Middle Eastern, Asian, other) of the eligible patients is collected	Index day (Date of hospitalization) to 24hours
Primary	Sociodemographic Characteristics of eligible patients	Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day	Index day (Date of hospitalization) to 24hours
Primary	Sociodemographic Characteristics	Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day	Index day (Date of hospitalization) to 24hours
Primary	Clinical characteristics	Comorbidities info of the eligible patients is recorded on Index day	Index day (Date of hospitalization) to 24hours
Primary	Clinical Characteristics	Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day	Index day (Date of hospitalization) to 24hours
Primary	FXa inhibitor characteristics	At index date the following FXa inhibitor characteristics will be described : Indication ,type and dose pf FXa Inhibitor	Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours
Primary	ICH characteristics	The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours	Index day to 1 week
Primary	GCS score	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)	Index day to 24hours
Primary	mRS score	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	Index day to 24 hours
Primary	NIHSS score	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	Index date up to 24 hours
Primary	Haematoma volume	Haematoma volume based on baseline Imaging scans taken within 24 hours on the index date	Index day to 24 hours
Primary	BP (Systolic and Diastolic)	BP at Index date during hospital admission and in 6, 24, and 72 hours	Index day to 72 hours
Primary	Antihypertensive treatment	Antihypertensive treatment patterns during hospitalisation from Index date to 1 week	Index day to 1 Week
Primary	In-hospital mortality due to any cause	Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week)	Index date up to the death event during hospital stay (maximum 1 week)
Primary	Mortality at 30 days, post index event	Number of patients died between index date (date of hospitalization) up to 30 days	Index date up to 30 days
Primary	Mortality at 3 months post index event	Number of patients died between index date (date of hospitalization) up to 3 months	Index date up to 3 months
Primary	Mortality at 6 months post index event	Number of patients died between index date (date of hospitalization) up to 6 months	Index date up to 6 months
Primary	Type of discharge disposition	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	Hospital discharge to Maximum of 6 months
Secondary	Time from symptoms onset to hospital admission	Time between the onset of the bleeding symptoms to admission of patient in hospital in hours.	Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours
Secondary	Time from Hospital admission to time taken to do Imaging scan	Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour	Index day (Date of hospitalization) to Maximum of one hour
Secondary	Time from hospital admission to administration of any haemostatic therapy	Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour	Index day (Date of hospitalization) to Maximum of one hour
Secondary	Healthcare resource utilization during hospitalisation	The length of ICU stay of eligible patients in days from Index day to maximum of 1 week	Index day to maximum of 1 week
Secondary	Length of hospitalisation in days	The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week	Index day to maximum of 1 week
Secondary	Disability rate among survivors	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 hospital discharge (Maximum of 1 week from Index day)
Secondary	Disability rate among survivors	At three months, after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.	Index day to 3 months
Secondary	Health care resource utilization after hospital admission up 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.	Index date to 6 months
Secondary	Health care resource utilization within 6 months after hospital discharge.	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.	Hospital discharge up to 6 months
Secondary	Disability rate among survivors	At six months after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described.	Index day to Maximum of 6 months