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)
Not Applicable
Completed
- Conditions
- Red cell transfusionNot Applicable
- Registration Number
- ISRCTN17438123
- Lead Sponsor
- HS Blood and Transplant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence outcomes: <br>1. The proportion of enrolled participants for whom the transfusion policy was successfully followed<br>2. The proportion of red cell transfusions given in accordance with the randomisation policy where the correct dose was given<br>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<br>4. The percentage of pre-transfusion haemoglobin concentrations falling at or below, or above the threshold haemoglobin of the red cell transfusion threshold assigned<br>5. The percentage of post-transfusion haemoglobin concentrations falling below, or at and above the target haemoglobin of the red cell transfusion threshold assigned<br>6. Drop out: the proportion of randomised participants who were withdrawn from the study<br>7. Quality of Life (QoL) questionnaire compliance: the proportion of QoL questionnaires completed at each time point
- Secondary Outcome Measures
Name Time Method Clinical outcomes:<br>1. Death: all-cause mortality at Day 100 of HSCT<br>2. Clinically significant bleeding (WHO Grade 3-4)<br>3. Red cell exposure: the red cell transfusion volume per recipient weight (ml/Kg), number of red cell units administered and number of red cell transfusion episodes up to death/Day 100 of HSCT (whichever comes first)<br>4. Number of patient requiring an additional transfusion within 24 hours, and reason<br>5. Proportion of participants experiencing thromboembolic and ischaemic events<br>6. Transfusion reactions<br>7. Grade of acute graft versus host disease and Bearman toxicity score<br>8. Veno-occlusive disease<br>9. Admission to Paediatric Intensive Care (reason and duration of stay)<br>10. Number of platelet transfusions<br>11. Health related Quality of Life Scores.