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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- mRS score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who were treated with andexanet alfa.
- •Patients who were enrolled in any clinical trials during the study period.
结局指标
主要结局
mRS score
时间窗: 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
Clinical characteristics
时间窗: Index day (Date of hospitalization) to 24hours
Comorbidities info of the eligible patients is recorded on Index day
Sociodemographic Characteristics of eligible patients
时间窗: Index day (Date of hospitalization) to 24hours
Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day
FXa inhibitor characteristics
时间窗: 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
In-hospital mortality due to any cause
时间窗: 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
时间窗: 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
时间窗: Index day (Date of hospitalization) to 24hours
Race (Middle Eastern, Asian, other) of the eligible patients is collected
ICH characteristics
时间窗: Index day to 1 week
The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours
BP (Systolic and Diastolic)
时间窗: Index day to 72 hours
BP at Index date during hospital admission and in 6, 24, and 72 hours
Antihypertensive treatment
时间窗: Index day to 1 Week
Antihypertensive treatment patterns during hospitalisation from Index date to 1 week
Mortality at 6 months post index event
时间窗: Index date up to 6 months
Number of patients died between index date (date of hospitalization) up to 6 months
Clinical Characteristics
时间窗: Index day (Date of hospitalization) to 24hours
Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day
GCS score
时间窗: 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)
NIHSS score
时间窗: 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
Mortality at 3 months post index event
时间窗: Index date up to 3 months
Number of patients died between index date (date of hospitalization) up to 3 months
Type of discharge disposition
时间窗: 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
Sociodemographic Characteristics
时间窗: Index day (Date of hospitalization) to 24hours
Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day
Haematoma volume
时间窗: 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
时间窗: Index date up to 30 days
Number of patients died between index date (date of hospitalization) up to 30 days
次要结局
- Time from symptoms onset to hospital admission(Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours)
- Health care resource utilization within 6 months after hospital discharge.(Hospital discharge up to 6 months)
- Healthcare resource utilization during hospitalisation(Index day to maximum of 1 week)
- Disability rate among survivors(Index day to Maximum of 6 months)
- Health care resource utilization after hospital admission up to 6 months(Index date to 6 months)
- Time from Hospital admission to time taken to do Imaging scan(Index day (Date of hospitalization) to Maximum of one hour)
- Time from hospital admission to administration of any haemostatic therapy(Index day (Date of hospitalization) to Maximum of one hour)
- Length of hospitalisation in days(Index day to maximum of 1 week)