A Phase 3 interventional study of Red blood cell Transfusion in Hematologic Malignancies, sponsored by Ottawa Hospital Research Institute. Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-12.
Sponsored by Ottawa Hospital Research Institute · Phase 3, Interventional, and Supportive care
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.
The indications for HSCT may include, but not limited to the following diseases :
1,463 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.
This study's enrollment of 300 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L
Other: Red blood cell Transfusion
Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L
Other: Red blood cell Transfusion
Transfusion of Red blood cells to based on daily complete blood count
Quality of Life (QOL)/Function based on the FACT-BMT scale
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.
Time frame: 3 years
Transplant Related Mortality
Time frame: 100 days
Red Cell Transfusion
Time frame: 100 days
Platelet Transfusion
Time frame: 100 days
Acute Graft Versus Host Disease
Time frame: 100 days
Bleeding
Grade 3 or 4 by WHO scale
Time frame: 100 days
Serious Infections
All grade 4 and 5 infections (according to the CTCAE v.4)
Time frame: 100 days
Time to Non-relapse Mortality
Time frame: 100 days
Economic Evaluation/Quality of Life
EQ-5D
Time frame: 100 days
NCI Toxicity Scale
Time frame: 100 days
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute