Background: Pharmaceutical research in pediatrics has increased in recent years. As children are exceptionally vulnerable, care must be taken in the design of research studies to ensure minimal risk. One essential contributor of risk is blood sampling. EU (European Union) and Food and Drug Administration (FDA) guidelines confirm it is the responsibility of the research ethics board (REB) and the investigator to ensure safe volumes are drawn. The guidance from the literature is highly variable (table 1) and is dependent on the age of the participant. The EU guidance is the most conservative at 1% of blood volume in 24 hours, maximum 3% over 4 weeks. Consideration of patient health and need for clinical testing must also be taken in account.
Aims: We performed a literature search to identify Canadian Guidelines for research blood sampling volumes in pediatric patients.
Methods: An OVID/Pubmed search was performed using the following search terms: pediatrics; humans/blood specimen collection/ blood volume draw guidelines; ethics, research/nursing methodology research/ operations research/ research/ clinical nursing research/pharmaceutical research/ nursing research; Canada.mp or Canada. A Google search was performed of guidelines for blood collection volume for pediatric research in Canada.
Results: No results were returned from the OVID/pubmed search. No guidance from Health Canada was found regarding the safe volume of blood collection from pediatric patients in research. No evidence-based Canadian studies were located. Guidelines found from Canadian REBs were identified from the Hospital for Sick Children, Children’s Hospital of Eastern Ontario, University of British Columbia and Alberta Health Services (table 2). These guidelines were variable and referenced the World Health Organization and US-based guidelines and research.
Conclusions: There is a need to develop evidence-based guidance for Canadian sites regarding blood draw maximums for research involving pediatric patients to ensure minimal risk for participation.
|Reference Institution||Single draw percent of Total Blood Volume (TBV)||Single draw in mL/kg||Total allowable cumulative draw volume|
|USC/LA Children’s Hospital||2.5-2.7% (within 24 hours)||2mL/kg (within 24 hours)||4ml/kg within 30 days|
|Wayne State University||1%||0.8mL/kg||10% TBV or 8mL/kg within 8 weeks|
|Partners Human Research Committee||3.6-3.9%||<3mL/kg||<3mL/kg within 8 weeks|
|University of California Davis||2.5%||2mL/kg||5% TBV within 30 days|
|KEMRI-Wellcome Trust Research Programme, Kilifi||1.9-2.3%||1.7-2.4mL/kg||2008 guideline 1.3 %TBV for research purposes in addition to volume needed for routine care|
|Gambia Government – MRC Joint Ethics Committee||0.3 to 2.4%||2mL up to max 30mL depending on age of child||Within 3 months same as for single draw maximum|
|EU Directive 2001/20/EC (2008)||1%||0.8mL/kg||3% TBV during period of 4 weeks|
|Children’s Hospital of Pennsylvania||6%||5mL/kg||9.5 ml/kg maximum over any 8 week period|
[Table 1 Blood Volume Draw Guidelines for Research in Pediatric Participants]
|Reference Institution||Single draw % of Total Blood Volume (TBV)||Single draw in ml/kg||Total allowable cumulative draw volume||References|
|Hospital for Sick Children REB||5% (divided portions)||3.75-4mL/kg (divided portions)||5% TBV within 3 months||Pearson HA “Blood and Blood-forming Tissues” in Rudolph’s Pediatrics, McGraw-Hill, 21st Edition 2003 pg 1521|
|Children’s Hospital of Eastern Ontario||2.5%||2mL/kg||5% TBV monthly or 4ml/kg (should not occur more than 3 months in a row)||CMRC IRB, Chicago IL. (2006) Howie (2011) Bull World Health Organ 89: 46-53|
|University of British Columbia||2.5%||2mL/kg||5% TBV over 30 period (must occur no more than 3 consecutive months)||CMRC IRB, Chicago IL. (2006) Howie (2011) Bull World Health Organ 89: 46-53|
|Alberta Health Services||1%||1mL/kg||1% or 1ml/kg maximum volume in 24 hours||Ernst, D.J. Applied Phlebotomy. Lippincott Williams & Wilkins (2005)|
[Table 2: Canadian Research Ethics Board Guidelines for Allowable Blood Draw Volume for Research in Pediatric Participants]
To cite this abstract in AMA style:Hamilton K, Chan AK, Bhatt M. Canadian Guidelines Regarding Safe Blood-draw Volumes for Research in Pediatric Participants [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/canadian-guidelines-regarding-safe-blood-draw-volumes-for-research-in-pediatric-participants/. Accessed January 26, 2022.
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