Clinical Trial: EPO-4-Rhesus: Role of Darbepoetin Alfa in Reducing Late Anaemia in Neonates With Red Blood Cell Alloimmunization After Intrauterine Transfusions

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial on the Use of EPO to Reduce Top-up Transfusions in Neonates With Red Blood Cell Alloimmunization Treated With Intrauterine Transfusions

Brief Summary:

The mainstay of antenatal treatment of fetal anemia due to red cell alloimmunization is (serial) IUT. The mainstay of postnatal treatment in HDN is (1) intensive phototherapy and exchange transfusion to treat hyperbilirubinemia and prevent kernicterus, and (2) top-up transfusions to treat anemia. Up to 80% of infants with HDN treated with IUT require at least one top-up transfusions for late anemia during the first 3 months of life.

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.


Detailed Summary:
Sponsor: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Current Primary Outcome: Number of top-up transfusions required per infant [ Time Frame: First 3 months of life ]

Number of top-up transfusions required per infant


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of infants requiring a top-up transfusion [ Time Frame: First 3 months of life ]
    The percentage of infants requiring a top-up transfusion
  • Number of days of admission for top-up transfusions [ Time Frame: First 3 months of life ]
    Number of days of admission for top-up transfusions
  • Occurrence of hypertension [ Time Frame: 8 weeks (treatment course) ]
    The percentage of infants with a systolic blood pressure ≥ 2 SD above age adjusted mean systolic blood pressure during treatment
  • Occurrence of high ferritin levels [ Time Frame: 8 weeks (treatment course) ]
    The percentage of infants with ferritin levels >200 μg/L during treatment


Original Secondary Outcome: Same as current

Information By: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Dates:
Date Received: April 3, 2017
Date Started: June 2017
Date Completion: August 2020
Last Updated: May 18, 2017
Last Verified: May 2017