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Completed

NCT Number: NCT01237639

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

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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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences Centre, Hamilton, Ontario, Canada

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cell Transfusion

Other

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

Primary outcomes

  1. Quality of Life (QOL)/Function based on the FACT-BMT scale

    Time frame: 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 outcomes

  1. Transplant Related Mortality

    Time frame: 100 days

  2. Red Cell Transfusion

    Time frame: 100 days

  3. Platelet Transfusion

    Time frame: 100 days

  4. Acute Graft Versus Host Disease

    Time frame: 100 days

  5. Bleeding

    Time frame: 100 days

    Grade 3 or 4 by WHO scale

  6. Serious Infections

    Time frame: 100 days

    All grade 4 and 5 infections (according to the CTCAE v.4)

  7. Time to Non-relapse Mortality

    Time frame: 100 days

  8. Economic Evaluation/Quality of Life

    Time frame: 100 days

    EQ-5D

  9. NCI Toxicity Scale

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Blood Services
  • Canadian Institutes of Health Research (CIHR)
  • Hamilton Health Sciences Corporation
  • London Health Sciences Centre
  • Saskatchewan Cancer Centre
  • The Ottawa Hospital

Registry information

Official study title

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

Acronym: TRIST

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2010
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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