Whole blood
Other30mls/kg transfused over fours hours
NCT Number: NCT01461590
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.
Looking for future studies?
Notify Me60 day–12 year
All sexes
Interventional
Phase 2
Mbale Regional Referral Hospital, Mbale, Uganda
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.
We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30mls/kg transfused over fours hours
Time frame: 24 hours
Correction of severe anaemia to a Hb >6g/dL at 24 hours.
Prof Kathryn Maitland
Other
Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Acronym: Tx30
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06601712
Anemia, Hematologic Diseases
Abomey, Benin
View Trial DetailsNCT07082205
Anemia, Hematologic Diseases
Kisumu, Nyanza, Kenya
View Trial DetailsNCT02075970
Anemia, Anemia, Neonatal
Iowa City, Iowa, United States
View Trial DetailsNCT05750654
Anemia, Hematologic Diseases
Houston, Texas, United States
View Trial Details