@article{Kuijpers2016-yp,

title = {Severe anaemia associated with Plasmodium falciparum infection in 

 children: consequences for additional blood sampling for research},

author = {Laura Maria Francisca Kuijpers and Jessica Maltha and Issa Guiraud and B\'{e}renger Kabor\'{e} and Palpouguini Lompo and Hugo Devlieger and Chris Van Geet and Halidou Tinto and Jan Jacobs},

year  = {2016},

date = {2016-06-01},

journal = {Malar. J.},

volume = {15},

pages = {304},

abstract = {BACKGROUND: Plasmodium falciparum infection may cause severe 

 anaemia, particularly in children. When planning a diagnostic 

 study on children suspected of severe malaria in sub-Saharan 

 Africa, it was questioned how much blood could be safely sampled; 

 intended blood volumes (blood cultures and EDTA blood) were 6 mL 

 (children aged 2 months to \<12 years, data of age, weight and 

 haemoglobin value (Hb) were available. For each child, the 

 estimated TBV (TBVe) (mL) was calculated by multiplying the body 

 weight (kg) by the factor 80 (ml/kg). Next, TBVe was corrected 

 for the degree of anaemia to obtain the functional TBV (TBVf). 

 The correction factor consisted of the rate 'Hb of the child 

 divided by the reference Hb'; both the lowest ('best case') and 

 highest ('worst case') reference Hb values were used. Next, the 

 exact volume that a 3.8 % proportion of this TBVf would present 

 was calculated and this volume was compared to the blood volumes 

 that were intended to be sampled. RESULTS: When applied to the 

 Burkina Faso cohort, the simulation exercise pointed out that in 

 5.3 % (best case) and 11.4 % (worst case) of children the blood 

 volume intended to be sampled would exceed the volume as defined 

 by the 3.8 % safety guideline. Highest proportions would be in 

 the age groups 2-6 months (19.0 %; worst scenario) and 6 

 months-2 years (15.7 %; worst case scenario). A positive rapid 

 diagnostic test for P. falciparum was associated with an 

 increased risk of violating the safety guideline in the worst case scenario (p = 0.016). CONCLUSIONS: Blood sampling in 

 children for research in P. falciparum endemic settings may 

 easily violate the proposed safety guideline when applied to 

 TBVf. Ethical committees and researchers should be wary of this 

 and take appropriate precautions.},

keywords = {Blood specimen collection; Blood volume; Child; Practice   guidelines as topic},

pubstate = {published},

tppubtype = {article}

}