Maintaining a Higher Level of Haemoglobin: Effect on the White Cells After Bone Marrow Transplantation in Children.

NCT ID: NCT00937053

Last Updated: 2010-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this study is to determine if maintaining a high hemoglobin level in children that underwent bone marrow transplant will accelerate the neutrophil recovery.

Detailed Description

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.

Conditions

Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemoglobin below 120 g/dL

Group Type: EXPERIMENTAL

Transfusion level 120 g/dL

Intervention Type: OTHER

Patients whose hemoglobin falls below 120 g/dL will be transfused with red cells within 24 hours.

Platelet transfusion

Intervention Type: OTHER

Patients whose platelets fall below 10 x 10\*9 will be transfused with platelets

Hemoglobin below 70 g/dL

Group Type: ACTIVE_COMPARATOR

Transfusion level 70 g/dL

Intervention Type: OTHER

Patients whose hemoglobin falls below 70 g/dL will be transfused with red cells within 24 hours

Platelet transfusion

Intervention Type: OTHER

Patients whose platelets fall below 10 x 10\*9 will be transfused with platelets

Interventions

Transfusion level 120 g/dL

Patients whose hemoglobin falls below 120 g/dL will be transfused with red cells within 24 hours.

Intervention Type: OTHER

Transfusion level 70 g/dL

Patients whose hemoglobin falls below 70 g/dL will be transfused with red cells within 24 hours

Intervention Type: OTHER

Platelet transfusion

Patients whose platelets fall below 10 x 10\*9 will be transfused with platelets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients between 1 year of age and 18 years of age at the time of transplantation (18 years is the upper limit of childhood in CIBMTR definitions)

2. Patients planned to undergo a related or unrelated allogeneic bone marrow transplant for a malignant or benign disease (except for sickle cell disease)

3. Conditioning regimen must be myeloablative, i.e. include busulfan greater or equal to 12 mg/kg or Total Body Irradiation greater or equal to 10 Gy, except for patients with acquired severe aplastic anemia

4. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial

5. Patient must agree to receive blood transfusion

6. Patient (or their legal guardians) must sign an Informed consent Form

Exclusion Criteria

1. Patients receiving autologous bone marrow transplant, cord blood transplant or peripheral stem cell transplant

2. Sickle cell disease (since higher hemoglobin level increases blood viscosity and puts these patients at risk for stroke)

3. Hematopoietic growth factor (G-CSF, GM-CSF, stem cell factor, erythropoietin) planned before transplantation (post-transplant decision of hematopoietic growth factors administration as required by the patient's condition will be accepted)

4. Presence of an allo-antibody directed against red blood cells

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nancy Robitaille, MD

UNKNOWN

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHU Sainte-Justine, Research Center

Principal Investigators

Michel Duval, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Nancy Robitaille, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

Souther Alberta Children's Cancer Care Program, Calgary

Calgary, Alberta, Canada

Pediatric Bone Marrow Transplant Unit, British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Section of Blood and Marrow Transplant, The Hospital for Sick Children

Toronto, Ontario, Canada

Hematopoietic Stem Cell Transplantation Program, Sainte-Justine Hospital

Montreal, Quebec, Canada

Department of Hematology, The Montreal Children's Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

9967

Identifier Type: -

Identifier Source: org_study_id