NCT04001686

Ambispective Observational Study to Evaluate the Incidence and Management of Aplastic Anemia in Spain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Biogipuzkoa Health Research Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
OTHER	incidence aplastic anemia	Ambispective chart review

Timeline

• Start date: 2018-01-31
• Primary completion: 2021-09-01
• Completion: 2022-09-30
• First posted: 2019-06-28
• Last updated: 2021-08-10

Locations

1 site across 1 country: Spain