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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-10-31

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.

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Detailed Description

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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.

Conditions

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Hematologic Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Restrictive Red blood cell Transfusion

Transfusion Trigger of 70g/L with an aim to maintain Hemoglobin between 80-90g/L

Group Type EXPERIMENTAL

Red blood cell Transfusion

Intervention Type OTHER

Transfusion of Red blood cells to based on daily complete blood count

Liberal Red blood Cell Transfusion

Transfusion Trigger of 90g/L with an aim to maintain Hemoglobin between 100-110g/L

Group Type ACTIVE_COMPARATOR

Red blood cell Transfusion

Intervention Type OTHER

Transfusion of Red blood cells to based on daily complete blood count

Interventions

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Red blood cell Transfusion

Transfusion of Red blood cells to based on daily complete blood count

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No