Blood sample volumes in child health research: review of safe limits
Stephen RC Howie
Volume 89, Number 1, January 2011, 46-53
Table 2. Policies and recommendations on safe blood sample volume limits for paediatric clinical research as identified through a review of the literature
| Institution/Body | Maximum volume allowed for a single draw |
Maximum cumulative draw volume allowed | |
|---|---|---|---|
| % of TBV | ml/kg | ||
| Toronto Hospital for Sick Children Research Ethics Board |
5 | 3.75–4.0a | 5% of TBV within 3 months |
| USC/LA Children’s Hospital |
2.5–2.7 (within 24 hour)a | 2 | 4 ml/kg within 30 days |
| Wayne State University |
1 | 0.8 | 10% of TBV or 8 ml/kg within 8 weeks |
| Partners Human Research Committee |
3.6–3.9a | < 3 | < 3 ml/kg within 8 weeks |
| University of California Davis |
2.5 Note: Minimum blood Hb required at time of blood draw, 7 g/dl (9–10 g/dl if cardiorespiratory compromise present) |
2a | 5% of TBV within 30 days |
| Duke University |
For expedited IRB approval | 3 ml/kg or 50 ml total (whichever is less) over 8 weeks | |
| 2.5a (for review by convened IRB; note: special precautions and justification required for more than this limit) |
2, up to 200 ml total | 7 ml/kg over 8 weeks (up to 5 draws of 7 ml/kg per year) | |
| KEMRI–Wellcome Trust Research Programme, Kilifi, Kenyab | 1.9–2.3a (2005 guideline for total volume drawn) |
1.7–2.4 | Not stated |
| 1.3a (2008 guideline for volume drawn for research purposes in addition to volume needed for routine care) |
1 | 5 ml/kg within 8 weeks | |
| US Dept of Health and Human Services, Office for Human Research Protections |
3.8a | 3, up to 50 ml total | 3 ml/kg, up to 50 ml total within 8 weeks |
| Kauffman 2000 |
3.0 | 2.4a | Not stated |
| Gambia Government–MRC Joint Ethics Committee |
Range: 2.4 (e.g.1-kg infant) to 0.3 (e.g. 20-kg 4-year-old or 30-kg 9-year-old)a | 2, up to max 5 ml (age 0–4 yr); 10 ml (age 5–9 yr); 15 ml (age 10–14 yr); 30 ml (age ≥ 15 yr) | Within 3 months same as for one draw, “usually” |
Hb, haemoglobin; IRB, institutional review board; ml/kg, millilitres per kilogram of body weight; MRC, Medical Research Council; TBV, total blood volume.
a Calculated on the basis of a TBV of 75–80 ml/kg (in neonates, 100 ml/kg). Non-italicised content is quoted directly from the sources.
b Provided by the KEMRI–Wellcome Trust Research Programme, Kilifi, Kenya, in October 2006 with an updated version provided to the author in August 2009. These are local practice guidelines reflecting the latest recommendations of this institution.