The Effect of Maintaining a Higher Haemoglobin Level on Neutropenia Duration After Bone Marrow Transplantation in Children.
The investigators know that children requiring bone marrow transplant need to first go
through a myeloablative regimen, which induces a neutropenia. The length of the neutropenia
has an incidence on the risk of contracting bacterial and fungal infections that could be
lethal. It is then important to find ways to accelerate the neutrophil recovery, so patient
survival can be improved.
Studies conducted in the '70s and '80s suggested that if the hemoglobin level could be kept
at a higher level, then the neutrophil recovery would be accelerated. Other studies also
support the hypothesis that if the stem cells do not need to produce red cells because these
are being supplied through transfusions, then the stem cells would differentiate into
non-erythroid cell lines.
As of now, for patients undergoing a bone marrow transplant, it is standard practice to
transfuse with red cells based on the condition of the patient or if the hemoglobin level
falls below 70 g/L. Hematopoietic growth factors have been used to increase the speed of the
neutrophil recovery, but studies conducted so far do not demonstrate that mortality and
length of hospitalization have been reduced by the specific use of G-CSF. In more recent
studies, these agents have been shown to also have negative effects, such as delayed
platelet recovery and impaired immune recovery. In addition, the prophylactic use of G-CSF
was also associated with graft-versus-host disease, treatment-related mortality and death.
In conclusion, this study will determine if maintaining a higher hemoglobin level has an
effect on the neutrophil recovery after allogenic bone marrow transplantation in children.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to neutrophil engraftment (defined as the time from transplantation to the first of three consecutive days with a neutrophil count > 0,5 x 109/L, as used in the International Bone Marrow Transplant Registry (IBMTR) criteria).
First 100 days post HSCT
Michel Duval, MD
St. Justine's Hospital
Canada: Health Canada and FRSQ (Québec)