Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2014 Apr 25:12:67.
doi: 10.1186/1741-7015-12-67.

Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia

Peter Olupot-Olupot, Charles Engoru, Jennifer Thompson, Julius Nteziyaremye, Martin Chebet, Tonny Ssenyondo, Cornelius M Dambisya, Vicent Okuuny, Ronald Wokulira, Denis Amorut, Paul Ongodia, Ayub Mpoya, Thomas N Williams, Sophie Uyoga, Alex Macharia, Diana M Gibb, A Sarah Walker, Kathryn Maitland  1
Affiliations
Clinical Trial

Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia

Peter Olupot-Olupot et al. BMC Med. .

Abstract

Background: 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 hemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.

Methods: 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 36 months (interquartile range (IQR) 13 to 53)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.

Results: Median admission hemoglobin was 4.2 g/dl (IQR 3.1 to 4.9). Initial volume received followed the randomization strategy in 155 (97%) patients. By 24-hours, 70 (90%) children in the Tx30 arm had corrected SA compared to 61 (74%) in the Tx20 arm; cause-specific hazard ratio = 1.54 (95% confidence interval 1.09 to 2.18, P = 0.01). From admission to day 28 there was a greater hemoglobin increase from enrollment in Tx30 (global P <0.0001). Serious adverse events included one non-fatal allergic reaction and one death in the Tx30 arm. There were six deaths in the Tx20 arm (P = 0.12); three deaths were adjudicated as possibly related to transfusion, but none secondary to volume overload.

Conclusion: A higher initial transfusion volume prescribed at hospital admission was safe and resulted in an accelerated hematological recovery in Ugandan children with SA. Future testing in a large, pragmatic clinical trial to establish the effect on short and longer-term survival is warranted.

Trial registration: ClinicalTrials.Gov identifier: NCT01461590 registered 26 October 2011.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial flow.
Figure 2
Figure 2
Correction of severe anemia by 24 hours by study arm. Time to first hemoglobin>6mg/dl by study arm by study arm (primary outcome- correction of severe anemia).
Figure 3
Figure 3
Change in mean hemoglobin (3a) and lactate (3b) over follow up by study arm. a. Hemoglobin over 28 days. b. Lactate levels over 24 hours.
See this image and copyright information in PMC

Comment in

References

    1. de Benoist B, McLean E, Egli I, Cogswell M, Worldwide prevalence of anaemia 1993–2005. WHO global database on anaemia. In WHO report. 2008. http://whqlibdoc.who.int/publications/2008/9789241596657_eng.pdf [accessed 31 March 2014] (Geneva)
    1. Rowe AK, Rowe SY, Snow RW, Korenromp EL, Schellenberg JR, Stein C, Nahlen BL, Bryce J, Black RE, Steketee RW. The burden of malaria mortality among African children in the year 2000. Int J Epidemiol. 2006;35:691–704. doi: 10.1093/ije/dyl027. - DOI - PMC - PubMed
    1. Ala F, Allain JP, Bates I, Boukef K, Boulton F, Brandful J, Dax EM, El Ekiaby M, Farrugia A, Gorlin J, Hassall O, Lee H, Loua A, Maitland K, Mbanya D, Mukhtar Z, Murphy W, Opare-Sem O, Owusu-Ofori S, Reesink H, Roberts D, Torres O, Totoe G, Ullum H, Wendel S. External financial aid to blood transfusion services in sub-Saharan Africa: a need for reflection. PLoS Med. 2012;9:e1001309. doi: 10.1371/journal.pmed.1001309. - DOI - PMC - PubMed
    1. WHO Department of Blood Safety. Aide Memoire. In: Technology DoBSaC, editor. WHO/BCT/02.03. 1211 Geneva 27. Geneva: World Health Organization; 2002. pp. 1–2.
    1. WHO/FCH/CAH/00.01. Geneva: WHO: World Health Organization; 2000. Management of the child with a serious infection or severe malnutrition: guidelines for care at the first-referral level in developing countries.

Publication types

Associated data