A Phase 4 interventional study of erythropoietin in Hemolytic-Uremic Syndrome and Anemia, sponsored by Hospital General de Niños Pedro de Elizalde. Completed at 1 site in Argentina. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Hospital General de Niños Pedro de Elizalde · Phase 4, Interventional, and Supportive care
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This study will evaluate the impact of early administration of erythropoietin in the number of red blood cell transfusions in children with Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).
Introduction:
Anemia in STEC-HUS is treated with red blood cell (RBC) transfusions. It can causes hypervolemia, hyperkalemia, exacerbate the thrombotic state of the disease, transmit infectious agents and trigger antigenic sensitization. Anemia is mainly due to hemolysis, but deficit of erythropoietin synthesis (EPO) may aggravate it. Although recombinant human EPO is frequently used in children with STEC-HUS there is no adequate evidence of its benefit. If it is confirmed that EPO reduce the number of RBC transfusions, its administration could diminish the aforementioned risks and also reduce costs.
Objective:
To determine if EPO administration decreases the number of RBC transfusions and; secondarily, to assess if its levels influence on transfusion requirement.
Methodology:
Randomized, open controlled clinical trial. We will include 28 patients (14 per arm) \<18 years with STEC-HUS admitted to our hospital. They will be grouped after randomization:(1) One to standard of care (RBC transfusions with hemoglobin ≤7 mg / dl and/or hemodynamic instability) and (2) the other to standard of care plus EPO (50 u / kg subcutaneous three times weekly) and RBC transfusions with hemoglobin ≤7 mg / dl). Serum EPO will be measured by ELISA and together with the clinical and laboratory variables, association with RBC transfusions number will be sought. Written informed consent and assent when appropriate, will be requested prior to enter into the study.
28 studies on the registry are indexed under Hemolytic-Uremic Syndrome; 7 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 13 interventional studies indexed under Hemolytic-Uremic Syndrome.
Browse Hemolytic-Uremic Syndrome studies →Hospital General de Niños Pedro de Elizalde is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Erythropoietin plus standard of care (RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability)
Drug: erythropoietin
Standard of care: RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability
erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route
Also known as: EPO
Number of RBC transfusions
To determine if administration of erythropoietin decreases the number of RBC during the acute stage of hemolytic uremic syndrome
Time frame: At the end of the 36 month study recruiting period
Erythropoietin levels
To determine if erythropoietin levels correlate with RBC transfusions requirement.
Time frame: At the end of the 36 month study recruiting period
Plan to share: Yes — The authors will share the generated data with qualified external researchers during the next 5 years after article publication. All data provided will be anonymized to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: During the next 5 years after article publication.
Access criteria: Qualified external researchers
Ran from Jan 2019 to primary completion in Dec 2020, 23 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erythropoietin
Hospital General de Niños Pedro de Elizalde