Thrombosis Clinical Trial
Official title:
Retrospective Electronic Chart Review to Assess the Prevalence of PNH-clones Among Patients Identified With PNH Risk Factors
NCT number | NCT05884060 |
Other study ID # | B1172022000017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 20, 2018 |
Est. completion date | March 1, 2022 |
Verified date | May 2023 |
Source | AZ Delta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The present study is a non-interventional retrospective chart review study assessing the prevalence of PNH-clones in patients with PNH risk-factors aged ≥14 years and treated at our hospital. The objective of this study is to develop a PNH screening tool on the hospital Electronic Health Record (EHR) system. An algorithm defining PNH risk groups is developed.
Status | Completed |
Enrollment | 568 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Patient =14 years of age - At least 1 record encoded in the General Hospital Delta (AZ Delta) patient database (HiX) between 20 April 2018 and 1 March 2022 - A history or presence of at least one PNH risk factors identified following retrospective screening of electronic patient records Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Delta | Roeselare | West-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
AZ Delta | Alexion |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PNH risk factors translation into query codes that can be interpreted by a computer system for analysis | Three main PNH risk sub-cohorts were constructed, representing patients exhibiting PNH risk factors such as hemolytic anemia (group 1), bone marrow dysfunction (group 2) and thrombosis (group 3). To build these sub-cohorts, queries were created using a combination of structured and unstructured electronic health record (EHR) data, including lab results, diagnoses, medication, questionnaire data, text from medical and radiology reports, notes, and Internation Classification Codes (ICD-10). These sub-cohorts were validated by two hematologists who reviewed randomly selected patients, resulting in several iterations and query optimizations. | 2022 | |
Primary | Number of patients identified with high risk for PNH clone and per type of screening criteria by developing a computational screening algorithm | A computational algorithm was employed for a retrospective EHR analysis, to identify high-risk cohorts of potential PNH patients who need treatment from all registered patients, with maximum ability to find relevant cases. Three main PNH risk sub-cohorts were constructed, representing patients exhibiting PNH risk factors such as hemolytic anemia (group 1), bone marrow dysfunction (group 2) and thrombosis (group 3). These sub-cohorts were validated by two hematologists who reviewed randomly selected patients, resulting in several iterations and query optimizations. Sub-cohorts were subsequently merged and refined into high risk cohorts that undergo further analysis and manual review. Two hematologists independently reviewed and rated medical records to achieve a manual risk stratification of the high risk cohorts. | 2022 | |
Secondary | The number of patients at high risk for PNH, categorized by risk factor, across each medical department | To increase awareness of PNH risk factors by medical departments that need to consider PNH lab testing | 2023 |
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