Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation
- Conditions
- Hematologic Malignancies
- Interventions
- Other: Red blood cell Transfusion
- Registration Number
- NCT01237639
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
Transfusion of red blood cells (RBCs) is important for the care of patients undergoing stem cell transplantation. Stem cell transplants are used to treat blood cancers and bone marrow disorders. This involves the use of high doses of chemotherapy and/or radiation to kill cancer cells; but this damages the marrow and blood system. Blood stem cells are transplanted by infusing into the recipient and blood counts recover over 2-3 weeks. Before bone marrow recovery, RBCs are needed to support the patient. Higher hemoglobin in these high risk patients may have benefits such as better energy and organ function. However, research in other areas of medicine suggests that a higher red cell count may be dangerous. Taken together, it is unclear whether having a lower or higher red cell count is better for patients having a blood stem cell transplant. The investigators plan to study this by randomly assigning patients having a transplant to be transfused with RBCs either at a higher or lower hemoglobin level. In this way, the investigators will be able to accurately find out if there are any benefits or harms in having a lower or higher red cell count during the recovery period after blood stem cell transplantation.
- Detailed Description
1. Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT.
2. The indications for HSCT may include, but not limited to the following diseases :
1. Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse
2. Chronic Myeloid Leukemia in chronic, accelerated or blast phase
3. Chronic Lymphocytic Leukemia
4. Myelodysplastic Syndrome
5. Myeloproliferative Disorder
6. Lymphoma
7. Myeloma
3. All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy
- Pregnant or lactating at the time of enrollment
- Already received red cell transfusion after HSCT but prior to enrollment
- Unable/unwilling to provide informed consent.
- Patients receiving HSCT for non-malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restrictive Red blood cell Transfusion Red blood cell Transfusion Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L Liberal Red blood Cell Transfusion Red blood cell Transfusion Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L
- Primary Outcome Measures
Name Time Method Quality of Life (QOL)/Function based on the FACT-BMT scale 3 years The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to BMT patients.
- Secondary Outcome Measures
Name Time Method Transplant Related Mortality 100 days Platelet Transfusion 100 days Red Cell Transfusion 100 days Serious Infections 100 days All grade 4 and 5 infections (according to the CTCAE v.4)
Economic Evaluation/Quality of Life 100 days EQ-5D
NCI Toxicity Scale 100 days Acute Graft Versus Host Disease 100 days Bleeding 100 days Grade 3 or 4 by WHO scale
Time to Non-relapse Mortality 100 days
Trial Locations
- Locations (4)
Hamilton Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
London Health Sciences Centre, University Hospital
🇨🇦London, Ontario, Canada
Saskatchewan Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada