Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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Males or females aged 18 years or older who are undergoing either an autologous or allogeneic HSCT. The indications for HSCT may include, but not limited to the following diseases : Acute Leukemia, myeloid, lymphoid or biphenotypic in 1st, 2nd remission or in relapse Chronic Myeloid Leukemia in chronic, accelerated or blast phase Chronic Lymphocytic Leukemia Myelodysplastic Syndrome Myeloproliferative Disorder Lymphoma Myeloma All study patients must provide consent at least 1 day prior to scheduled HSCT and provide written informed consent.

Official Title
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Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation: The TRIST Study

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Other: Red blood cell Transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are aged 16-70 undergoing either an autologous or allogeneic HSCT for any hematologic malignancy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restrictive Red blood cell Transfusion<br>Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L | Other: Red blood cell Transfusion<br>* Transfusion of Red blood cells to based on daily complete blood count<br>|
| Active Comparator: Liberal Red blood Cell Transfusion<br>Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L | Other: Red blood cell Transfusion<br>* Transfusion of Red blood cells to based on daily complete blood count<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant Related Mortality |  | 100 days | 
| Red Cell Transfusion |  | 100 days | 
| Platelet Transfusion |  | 100 days | 
| Acute Graft Versus Host Disease |  | 100 days | 
| Bleeding | Grade 3 or 4 by WHO scale | 100 days | 
| Serious Infections | All grade 4 and 5 infections (according to the CTCAE v.4) | 100 days | 
| Time to Non-relapse Mortality |  | 100 days | 
| Economic Evaluation/Quality of Life | EQ-5D | 100 days | 
| NCI Toxicity Scale |  | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red Cells, Transfusion, Trigger, Threshold, Hematopoietic Stem cell Transplantation