Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2017-10-31
2020-08-31
Brief Summary
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Detailed Description
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Several risk factors for late anemia have been reported, including serial IUT (due to bone marrow suppression), severity of HDN, reduced use of exchange transfusions during the neonatal period and reduced survival of transfused red blood cells. Finally, erythropoietin deficiency is also considered as a possible contributing factor to late anemia.
EPO has been increasingly used in neonates to prevent or reduce neonatal anemia without short or long-term adverse effects. Several small studies and casuistic reports suggest that neonates with HDN may benefit from treatment with EPO to reduce the risk of delayed anemia and subsequent top-up transfusions. However, other authors found that EPO may be less effective than expected. Due to the lack of evidence, routine use of EPO is currently not recommended. To determine a role for EPO in this group of patients, a well-designed randomized controlled clinical trial of sufficient sample size is required. Potentially, EPO stabilizes the hemoglobin levels of these infants and thus prevents top-up transfusions and extra admissions, creating a more stable and natural postnatal course for patients with HDN.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Darbepoetin alfa group
Group treated with darbepoetin alfa (Aranesp) 10microg/kg once a week for a period of 8 weeks.
Darbepoetin Alfa
Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
Control group
"Standard care" which involves close monitoring of hemoglobin levels and if necessary, top-up red cell transfusion.
No interventions assigned to this group
Interventions
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Darbepoetin Alfa
Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
OTHER
Responsible Party
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Principal Investigators
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Masja de Haas, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sanquin Research
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Ree IMC, de Haas M, van Geloven N, Juul SE, de Winter D, Verweij EJT, Oepkes D, van der Bom JG, Lopriore E. Darbepoetin alfa to reduce transfusion episodes in infants with haemolytic disease of the fetus and newborn who are treated with intrauterine transfusions in the Netherlands: an open-label, single-centre, phase 2, randomised, controlled trial. Lancet Haematol. 2023 Dec;10(12):e976-e984. doi: 10.1016/S2352-3026(23)00285-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P17.102
Identifier Type: -
Identifier Source: org_study_id
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