Blood Sample Volumes in Child Health Research: Review of Safe limits/Les Volumes Des Echantillons Sanguins Dans la Recherche En Matiere De Sante Infantile: Examen Des Limites De Securite/ Investigaciones Sanitarias Sobre El Volumen De Las Muestras De Sangre En Ninos: Revision De Los Limites De Seguridad

By Howie, Stephen R. C. | Bulletin of the World Health Organization, January 2011 | Go to article overview

Blood Sample Volumes in Child Health Research: Review of Safe limits/Les Volumes Des Echantillons Sanguins Dans la Recherche En Matiere De Sante Infantile: Examen Des Limites De Securite/ Investigaciones Sanitarias Sobre El Volumen De Las Muestras De Sangre En Ninos: Revision De Los Limites De Seguridad


Howie, Stephen R. C., Bulletin of the World Health Organization


Objective To determine paediatric blood sample volume limits that are consistent with physiological "minimal risk."

Methods A literature review was performed to search for evidence concerning the adverse effects of blood sampling in children and for guidelines on sampling volume in paediatric research. The search included Medline, EMBASE, other web-based and non-web-based sources and the bibliographies of the sources identified. Experts were also consulted.

Findings Five studies and nine guidelines were identified. Existing guidelines specify paediatric blood sample volume limits ranging from 1% to 5% of total blood volume (TBV) over 24 hours and up to 10% of TBV over 8 weeks. The evidence available is limited and includes findings from non-randomized studies showing a minimal risk with one-off sampling of up to 5% of TBV. Conclusion The evidence available is consistent with the conclusion that all identified guidelines are within the limits of "minimal risk." However, more and better evidence is required to draw firmer conclusions. Researchers and institutional review boards need to take into account the total sampling volume needed for both clinical care and research rather than for each alone. The child's general state of health should be considered and extra caution should be observed particularly with children whose illness can deplete blood volume or haemoglobin or hinder their replenishment. Local policies must also address the appropriateness and local acceptability of collection procedures and of the blood volumes drawn.

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Resume

Objectif Determiner les limites du volume de l'echantillon sanguin pediatrique qui soient pertinentes avec le <> physiologique.

Methodes II a ete procede a un examen de la documentation afin de trouver d'une part, des elements probants concernant les effets indesirables du prelevement d'echantillons sanguins chez l'enfant et d'autre part, des directives relatives au volume de l'echantillonnage dans la recherche pediatrique. Cette recherche englobait Medline, EMBASE, d'autres sources Internet et non-lnternet et les bibliographies des sources identifiees. Des experts ont egalement ete consultes.

Resultats Cinq etudes et neuf directives ont ete identifiees. Les directives existantes specifient que les limites du volume de l'echantillon sanguin pediatrique varient de 1 a 5% du volume sanguin (VST) sur 24 heures et jusqu'a 10% du VST sur 8 semaines. Les preuves dont on dispose sont limitees et comprennent les constatations d'etudes non randomisees montrant un risque minimal avec un echantillon ponctuel allant jusqu'a 5% du VST.

Conclusion Les elements de preuve dont nous disposons sont en coherence avec la conclusion selon laquelle toutes les directives identifiees sont comprises dans les limites du <>. Toutefois, davantage de preuves plus solides sont necessaires pour tirer des conclusions irrefutables. Les chercheurs et les comites institutionnels d'evaluation doivent prendre en compte le volume d'echantillon total necessaire a la fois aux soins cliniques et a la recherche, plutot que leurs besoins respectifs pris separement. Uetat de sante general de l'enfant doit etre evalue et un surcroit de precautions doit etre pris, notamment chez les enfants dont la pathologie est susceptible d'appauvrir le volume sanguin ou l'hemoglobine ou de freiner leur reconstitution. Les politiques locales doivent egalement traiter de l'adequation et de l'acceptabilite locale des procedures de collecte et des volumes sanguins preleves.

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Resumen

Objetivo Determinar los limites del volumen de las muestras de sangre en pacientes pediatricos para alcanzar el <>. Metodos Se realizo una revision bibliografica para buscar datos relacionados con los efectos adversos de la extraccion de muestras de sangre en ninos y para hallar unas directrices sobre el volumen de extraccion en las investigaciones pediatricas. …

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Blood Sample Volumes in Child Health Research: Review of Safe limits/Les Volumes Des Echantillons Sanguins Dans la Recherche En Matiere De Sante Infantile: Examen Des Limites De Securite/ Investigaciones Sanitarias Sobre El Volumen De Las Muestras De Sangre En Ninos: Revision De Los Limites De Seguridad
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