Immediate Versus Triggered Transfusion for Children with Uncomplicated Severe Anaemia

Kathryn Maitland; Sarah Kiguli; Peter Olupot-Olupot; Charles Engoru; Jane Mallewa; Pedro Rafael Saramago Goncalves; Elisabeth George; Diana M. Gibb; A. Sarah Walker

doi:10.1056/NEJMoa1900105

Immediate Versus Triggered Transfusion for Children with Uncomplicated Severe Anaemia

Kathryn Maitland, Sarah Kiguli, Peter Olupot-Olupot, Charles Engoru, Jane Mallewa, Pedro Rafael Saramago Goncalves, Elisabeth George, Diana M. Gibb, A. Sarah Walker

Centre for Health Economics

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The World Health Organization recommends a haemoglobin transfusion threshold of <4g/dl for children with uncomplicated anaemia. High rates of mortality and re-admission in African children with severe anaemia suggest a less restrictive transfusion threshold might improve outcomes. Methods: The TRACT factorial open-label trial randomized Ugandan/Malawian children aged 2 months to 12 years with haemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20-30mls/kg whole-blood equivalent or transfusion triggered by new severity signs or haemoglobin fall to <4g/dl. Three other randomizations investigated blood volume, post-discharge micronutrients and/or cotrimoxazole. The primary endpoint was 28-day mortality. Results: 1565 children (median 26 months; 977(62%) with malaria) were randomized to immediate (n=778) or triggered (n=787) transfusion and followed for 180-days (71(5%) lost-to-follow-up). 778(100%) immediate vs 386(49%) triggered children were transfused during admission, a median 1.2 vs 24.9 hours from randomization: receiving mean (standard deviation) 314(228) vs 142(224) mls total whole-blood equivalent respectively. 7(1%) immediate vs 13(2%) triggered children died before 28-days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs 47(6%) respectively before 180-days (HR=0.75 (0.48-1.16) p=0.19), with no evidence of interaction with other randomizations (p>0.2) nor evidence of differences between groups in re-admissions (p=0.36), serious adverse events (p=0.36) nor in haemoglobin recovery at 180-days (p=0.08). Length-of-stay was mean 0.9 days longer in the triggered group. Conclusions: There was no evidence of differences in clinical outcomes over 6 months with triggered vs immediate transfusion. Triggered transfusion reduced blood-volume requirements by 60% but increased length-of-stay by 20% and required repeated haemoglobin monitoring and surveillance.

Original language	English
Pages (from-to)	407-419
Number of pages	13
Journal	New England Journal of Medicine
DOIs	https://doi.org/10.1056/NEJMoa1900105
Publication status	Published - 1 Aug 2019

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@article{b281f02c446d49bd99c5480ae4fa0e00,

title = "Immediate Versus Triggered Transfusion for Children with Uncomplicated Severe Anaemia",

abstract = "Background: The World Health Organization recommends a haemoglobin transfusion threshold of <4g/dl for children with uncomplicated anaemia. High rates of mortality and re-admission in African children with severe anaemia suggest a less restrictive transfusion threshold might improve outcomes. Methods: The TRACT factorial open-label trial randomized Ugandan/Malawian children aged 2 months to 12 years with haemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20-30mls/kg whole-blood equivalent or transfusion triggered by new severity signs or haemoglobin fall to <4g/dl. Three other randomizations investigated blood volume, post-discharge micronutrients and/or cotrimoxazole. The primary endpoint was 28-day mortality. Results: 1565 children (median 26 months; 977(62%) with malaria) were randomized to immediate (n=778) or triggered (n=787) transfusion and followed for 180-days (71(5%) lost-to-follow-up). 778(100%) immediate vs 386(49%) triggered children were transfused during admission, a median 1.2 vs 24.9 hours from randomization: receiving mean (standard deviation) 314(228) vs 142(224) mls total whole-blood equivalent respectively. 7(1%) immediate vs 13(2%) triggered children died before 28-days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs 47(6%) respectively before 180-days (HR=0.75 (0.48-1.16) p=0.19), with no evidence of interaction with other randomizations (p>0.2) nor evidence of differences between groups in re-admissions (p=0.36), serious adverse events (p=0.36) nor in haemoglobin recovery at 180-days (p=0.08). Length-of-stay was mean 0.9 days longer in the triggered group. Conclusions: There was no evidence of differences in clinical outcomes over 6 months with triggered vs immediate transfusion. Triggered transfusion reduced blood-volume requirements by 60% but increased length-of-stay by 20% and required repeated haemoglobin monitoring and surveillance. ",

author = "Kathryn Maitland and Sarah Kiguli and Peter Olupot-Olupot and Charles Engoru and Jane Mallewa and {Saramago Goncalves}, {Pedro Rafael} and Elisabeth George and Gibb, {Diana M.} and Walker, {A. Sarah}",

year = "2019",

month = aug,

day = "1",

doi = "10.1056/NEJMoa1900105",

language = "English",

pages = "407--419",

journal = "New England Journal of Medicine ",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

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TY - JOUR

T1 - Immediate Versus Triggered Transfusion for Children with Uncomplicated Severe Anaemia

AU - Maitland, Kathryn

AU - Kiguli, Sarah

AU - Olupot-Olupot, Peter

AU - Engoru, Charles

AU - Mallewa, Jane

AU - Saramago Goncalves, Pedro Rafael

AU - George, Elisabeth

AU - Gibb, Diana M.

AU - Walker, A. Sarah

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Background: The World Health Organization recommends a haemoglobin transfusion threshold of <4g/dl for children with uncomplicated anaemia. High rates of mortality and re-admission in African children with severe anaemia suggest a less restrictive transfusion threshold might improve outcomes. Methods: The TRACT factorial open-label trial randomized Ugandan/Malawian children aged 2 months to 12 years with haemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20-30mls/kg whole-blood equivalent or transfusion triggered by new severity signs or haemoglobin fall to <4g/dl. Three other randomizations investigated blood volume, post-discharge micronutrients and/or cotrimoxazole. The primary endpoint was 28-day mortality. Results: 1565 children (median 26 months; 977(62%) with malaria) were randomized to immediate (n=778) or triggered (n=787) transfusion and followed for 180-days (71(5%) lost-to-follow-up). 778(100%) immediate vs 386(49%) triggered children were transfused during admission, a median 1.2 vs 24.9 hours from randomization: receiving mean (standard deviation) 314(228) vs 142(224) mls total whole-blood equivalent respectively. 7(1%) immediate vs 13(2%) triggered children died before 28-days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs 47(6%) respectively before 180-days (HR=0.75 (0.48-1.16) p=0.19), with no evidence of interaction with other randomizations (p>0.2) nor evidence of differences between groups in re-admissions (p=0.36), serious adverse events (p=0.36) nor in haemoglobin recovery at 180-days (p=0.08). Length-of-stay was mean 0.9 days longer in the triggered group. Conclusions: There was no evidence of differences in clinical outcomes over 6 months with triggered vs immediate transfusion. Triggered transfusion reduced blood-volume requirements by 60% but increased length-of-stay by 20% and required repeated haemoglobin monitoring and surveillance.

AB - Background: The World Health Organization recommends a haemoglobin transfusion threshold of <4g/dl for children with uncomplicated anaemia. High rates of mortality and re-admission in African children with severe anaemia suggest a less restrictive transfusion threshold might improve outcomes. Methods: The TRACT factorial open-label trial randomized Ugandan/Malawian children aged 2 months to 12 years with haemoglobin 4-6g/dl and no severity signs to immediate transfusion with 20-30mls/kg whole-blood equivalent or transfusion triggered by new severity signs or haemoglobin fall to <4g/dl. Three other randomizations investigated blood volume, post-discharge micronutrients and/or cotrimoxazole. The primary endpoint was 28-day mortality. Results: 1565 children (median 26 months; 977(62%) with malaria) were randomized to immediate (n=778) or triggered (n=787) transfusion and followed for 180-days (71(5%) lost-to-follow-up). 778(100%) immediate vs 386(49%) triggered children were transfused during admission, a median 1.2 vs 24.9 hours from randomization: receiving mean (standard deviation) 314(228) vs 142(224) mls total whole-blood equivalent respectively. 7(1%) immediate vs 13(2%) triggered children died before 28-days (hazard ratio[HR]=0.54 (95% CI 0.22-1.36) p=0.19), and 35(4%) vs 47(6%) respectively before 180-days (HR=0.75 (0.48-1.16) p=0.19), with no evidence of interaction with other randomizations (p>0.2) nor evidence of differences between groups in re-admissions (p=0.36), serious adverse events (p=0.36) nor in haemoglobin recovery at 180-days (p=0.08). Length-of-stay was mean 0.9 days longer in the triggered group. Conclusions: There was no evidence of differences in clinical outcomes over 6 months with triggered vs immediate transfusion. Triggered transfusion reduced blood-volume requirements by 60% but increased length-of-stay by 20% and required repeated haemoglobin monitoring and surveillance.

U2 - 10.1056/NEJMoa1900105

DO - 10.1056/NEJMoa1900105

M3 - Article

SN - 0028-4793

SP - 407

EP - 419

JO - New England Journal of Medicine

JF - New England Journal of Medicine

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