Condition or disease | Intervention/treatment |
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Aplastic Anemia | Other: incidence aplastic anemia |
This is a national, multicenter, ambispective, observational post-authorization study (EPA-SP for its acronym in Spanish) to describe the incidence, clinical management and outcome of aplastic anemia in hospitals throughout Spain.
The study includes a retrospective chart review to identify all cases of aplastic anemia diagnosed between January 2010 and the date of the study initiation and a prospective study to detect new cases of aplastic anemia during an 18-month period since the study initiation in the participant hospitals. The study is also designed to collect both retrospective and prospective data on clinical management and outcome of patients with confirmed aplastic anemia. All patients included in the study, including those cases of aplastic anemia identified since 2010 until the study initiation through the retrospective chart review that are alive at the time of inclusion in the study, will be followed up until death or lost-to-follow-up or until 6 months after the last patient is enrolled in the study.
The study consists of a baseline visit, follow-up visits every 6 months (± 15 days) until death or lost-to follow-up or up to 6 months after the last patient is enrolled in the study, and a final visit (final/premature withdrawal visit) which will be performed at the study end (6 months after the last patient is enrolled) or in case of premature withdrawal, except for patient withdrawal of consent, loss-to-follow-up or death.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 88 participants |
Observational Model: | Other |
Time Perspective: | Other |
Target Follow-Up Duration: | 6 Months |
Official Title: | Ambispective Observational Study to Evaluate the Incidence and Management of Aplastic Anemia in Spain |
Actual Study Start Date : | January 31, 2018 |
Estimated Primary Completion Date : | July 30, 2019 |
Estimated Study Completion Date : | July 30, 2022 |
The number of males and females diagnosed with aplastic anemia per one million people per year will be calculated.
The number of patients diagnosed with aplastic anemia in each age category considered (in the statistical plan) per one million people per year will be calculated.
Hematological response will be assessed on the basis of hemoglobin, platelet and absolute neutrophil count every 3 months (90 days) according to routine clinical practice.
Hematological response will be classified as response (CR and PR vs. NR). CR and PR to treatment will be defined as follows:
CR: haemoglobin levels ≥120 g/L, platelet count ≥100 x 109/L, and neutrophil count ≥1.5 x 109/L.
PR: haemoglobin levels ≥80 g/L, platelet count ≥20 x 109/L (transfusion independent), and neutrophil count ≥0.5 x 109/L.
Tracking Information | |||||
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First Submitted Date | June 26, 2019 | ||||
First Posted Date | June 28, 2019 | ||||
Last Update Posted Date | June 28, 2019 | ||||
Actual Study Start Date | January 31, 2018 | ||||
Estimated Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
To evaluate the incidence of aplastic anemia [ Time Frame: 2010-2022 ] The primary endpoint of the study is the number of cases of aplastic anemia per year recorded in the databases of the participant hospitals from January 2010 and the date of the study initiation (retrospective analysis) and all new cases of aplastic anemia detected per year (prospective analysis) during an 18-month period since study initation.
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Ambispective Observational Study to Evaluate the Incidence and Management of Aplastic Anemia in Spain | ||||
Official Title | Ambispective Observational Study to Evaluate the Incidence and Management of Aplastic Anemia in Spain | ||||
Brief Summary | This is a national, multicenter, ambispective, observational post-authorization study (EPA-SP for its acronym in Spanish) to describe the incidence, clinical management and outcome of aplastic anemia in hospitals throughout Spain. | ||||
Detailed Description |
This is a national, multicenter, ambispective, observational post-authorization study (EPA-SP for its acronym in Spanish) to describe the incidence, clinical management and outcome of aplastic anemia in hospitals throughout Spain. The study includes a retrospective chart review to identify all cases of aplastic anemia diagnosed between January 2010 and the date of the study initiation and a prospective study to detect new cases of aplastic anemia during an 18-month period since the study initiation in the participant hospitals. The study is also designed to collect both retrospective and prospective data on clinical management and outcome of patients with confirmed aplastic anemia. All patients included in the study, including those cases of aplastic anemia identified since 2010 until the study initiation through the retrospective chart review that are alive at the time of inclusion in the study, will be followed up until death or lost-to-follow-up or until 6 months after the last patient is enrolled in the study. The study consists of a baseline visit, follow-up visits every 6 months (± 15 days) until death or lost-to follow-up or up to 6 months after the last patient is enrolled in the study, and a final visit (final/premature withdrawal visit) which will be performed at the study end (6 months after the last patient is enrolled) or in case of premature withdrawal, except for patient withdrawal of consent, loss-to-follow-up or death. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Other Time Perspective: Other |
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Target Follow-Up Duration | 6 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The study population consists of all consecutive patients diagnosed with aplastic anemia between January 2010 and the date of finalization of the 18-month inclusion period | ||||
Condition | Aplastic Anemia | ||||
Intervention | Other: incidence aplastic anemia
Ambispective chart review
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
88 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 30, 2022 | ||||
Estimated Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Aplasia is defined by a cellularity of the bone marrow <25% and the presence of less than the following: (i) hemoglobin <100 g / l (ii) platelet count <50 x109 / l (iii) Neutrophil count < 1.5 x 109 / l.
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | |||||
Listed Location Countries | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04001686 | ||||
Other Study ID Numbers | AIBiodonostia | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Asociacion Instituto Biodonostia | ||||
Study Sponsor | Asociacion Instituto Biodonostia | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Asociacion Instituto Biodonostia | ||||
Verification Date | June 2019 |