A small pilot feasibility study for a possible randomised control trial comparing clinical outcomes and quality of life following two different transfusion strategies in children undergoing allogeneic hematopoietic stem cell transplant (HSCT)

Red Cell Transfusion in Paediatric Allogeneic HSCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17438123

Enrollment

Registered

2019-05-23

Start date

2019-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Red cell transfusion Other

Interventions

This is a small pilot feasibility study for a possible randomised controlled trial comparing clinical outcomes and quality of life following two different transfusion strategies in children undergoing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children undergoing allogeneic HSCT 2. Aged at least 1 year and under 18 years at time of consent 3. Expected to require red cell transfusions

Exclusion criteria

Exclusion criteria: 1. Patients for whom the attending haematologist feels allocation to either a restrictive or liberal policy of red cell transfusion is not appropriate (e.g. acutely unwell, bleeding or ‘unstable’. 2. Children undergoing HSCT for haemoglobinopathy or red cell aplasia.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 20/01/2025: Recruitment: The percentage of eligible children recruited and randomised into the study Adherence: The percentage of Hb measurements where appropriate action was taken in accordance with the randomised policy Previous primary outcome measures: Adherence outcomes: 1. The proportion of enrolled participants for whom the transfusion policy was successfully followed 2. The proportion of red cell transfusions given in accordance with the randomisation policy where the correct dose was given 3. The mean pre-transfusion, post-transfusion and overall haemoglobin concentration (g/L) up to day 100 of HSCT and the difference between the two arms 4. The percentage of pre-transfusion haemoglobin concentrations falling at or below, or above the threshold haemoglobin of the red cell transfusion threshold assigned 5. The percentage of post-transfusion haemoglobin concentrations falling below, or at and above the target haemoglobin of the red cell transfusion threshold assigned 6. Drop out: the proportion of randomised participants who were withdrawn from the study 7. Quality of Life (QoL) questionnaire compliance: the proportion of QoL questionnaires completed at each time point	—

Measure

Time frame

Current primary outcome measures as of 20/01/2025: Recruitment: The percentage of eligible children recruited and randomised into the study Adherence: The percentage of Hb measurements where appropriate action was taken in accordance with the randomised policy Previous primary outcome measures: Adherence outcomes: 1. The proportion of enrolled participants for whom the transfusion policy was successfully followed 2. The proportion of red cell transfusions given in accordance with the randomisation policy where the correct dose was given 3. The mean pre-transfusion, post-transfusion and overall haemoglobin concentration (g/L) up to day 100 of HSCT and the difference between the two arms 4. The percentage of pre-transfusion haemoglobin concentrations falling at or below, or above the threshold haemoglobin of the red cell transfusion threshold assigned 5. The percentage of post-transfusion haemoglobin concentrations falling below, or at and above the target haemoglobin of the red cell transfusion threshold assigned 6. Drop out: the proportion of randomised participants who were withdrawn from the study 7. Quality of Life (QoL) questionnaire compliance: the proportion of QoL questionnaires completed at each time point

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Secondary

Measure	Time frame
Current secondary outcome measures as of 20/01/2025: Adherence outcomes: 1. The proportion of enrolled participants for whom the transfusion policy was successfully followed 2. The proportion of RBC transfusions given in accordance with the randomised policy where the correct dose was given 3. The mean pre-transfusion, post-transfusion and overall Hb concentration up to Day 100 of HSCT and the difference between the two arms 4. The percentage of pre-transfusion Hb concentrations falling at or below, or above the threshold Hb of the red cell transfusion threshold assigned 5. The percentage of post-transfusion Hb concentrations falling below, or at and above the target Hb of the red cell transfusion threshold assigned 6. Drop-out: the proportion of randomised participants who were withdrawn from the study 7. Quality of life (QoL) questionnaire compliance: the proportion of QoL questionnaires completed at each time point Clinical outcomes: 1. Death: All-cause mortality at Day 100 of HSCT 2. Clinically significant bleeding (WHO Grade 3-4) 3. Red Blood Cell Exposure: The RBC transfusion volume per recipient weight (ml/Kg), number of red blood cell units administered and number of RBC transfusion episodes up to death/Day 100 of HSCT (whichever comes first). Number of patients requiring an additional transfusion within 24 hours, and reason 4. Proportion of participants experiencing thromboembolic and ischaemic events 5. Transfusion reactions 6. Grade of acute graft versus host disease and Bearman toxicity score 7. Veno-occlusive disease 8. Admission to Paediatric Intensive Care (reason and duration of stay) 9. Number of platelet transfusions 10. Health-related QoL scores Previous secondary outcome measures: Clinical outcomes: 1. Death: all-cause mortality at Day 100 of HSCT 2. Clinically significant bleeding (WHO Grade 3-4) 3. Red cell exposure: the red cell transfusion volume per recipient weight (ml/Kg), number of red cell units administered and numb	—

Measure

Time frame

Current secondary outcome measures as of 20/01/2025: Adherence outcomes: 1. The proportion of enrolled participants for whom the transfusion policy was successfully followed 2. The proportion of RBC transfusions given in accordance with the randomised policy where the correct dose was given 3. The mean pre-transfusion, post-transfusion and overall Hb concentration up to Day 100 of HSCT and the difference between the two arms 4. The percentage of pre-transfusion Hb concentrations falling at or below, or above the threshold Hb of the red cell transfusion threshold assigned 5. The percentage of post-transfusion Hb concentrations falling below, or at and above the target Hb of the red cell transfusion threshold assigned 6. Drop-out: the proportion of randomised participants who were withdrawn from the study 7. Quality of life (QoL) questionnaire compliance: the proportion of QoL questionnaires completed at each time point Clinical outcomes: 1. Death: All-cause mortality at Day 100 of HSCT 2. Clinically significant bleeding (WHO Grade 3-4) 3. Red Blood Cell Exposure: The RBC transfusion volume per recipient weight (ml/Kg), number of red blood cell units administered and number of RBC transfusion episodes up to death/Day 100 of HSCT (whichever comes first). Number of patients requiring an additional transfusion within 24 hours, and reason 4. Proportion of participants experiencing thromboembolic and ischaemic events 5. Transfusion reactions 6. Grade of acute graft versus host disease and Bearman toxicity score 7. Veno-occlusive disease 8. Admission to Paediatric Intensive Care (reason and duration of stay) 9. Number of platelet transfusions 10. Health-related QoL scores Previous secondary outcome measures: Clinical outcomes: 1. Death: all-cause mortality at Day 100 of HSCT 2. Clinically significant bleeding (WHO Grade 3-4) 3. Red cell exposure: the red cell transfusion volume per recipient weight (ml/Kg), number of red cell units administered and numb

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Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026