Recruiting

Red Blood Cell Transfusion

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02099669

Conditions

Myelodysplastic Syndromes (MDS)

Quality of Life

Red Blood Cell (RBC) Transfusions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Red Blood Cell Transfusions

Study Details

Brief summary:

Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone marrow function that may progress to acute myeloid leukemia. Many patients become red blood cell transfusion-dependent. Transfusion dependence is associated with inferior quality of life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L (normal hemoglobin > 120-130g/L). The question is: would a higher hemoglobin target lead to improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to associated time commitments, expense, transfusion reactions etc). Several groups have prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of 15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program has been conducting prospective assessments of QOL since 2007 in all registered and consented patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients) revealed that, compared with an age-matched healthy general population, MDS patients have inferior QOL. Transfusion dependence and anemia were independently predictive of poor functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100 g/L seemed to be the key threshold for improvement in function and symptom scores. The investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients are too low and this may account for their inferior quality of life. Our goal is to compare the effect on QOL of a restrictive strategy (which is the current standard of care), with a liberal transfusion strategy in a large randomized controlled trial of transfusion dependent MDS outpatients. Before embarking on such an endeavor, the investigators must first prove feasibility in a smaller pilot randomized controlled trial.

Conditions

Myelodysplastic Syndromes (MDS)

Quality of Life

Red Blood Cell (RBC) Transfusions

Study ID

NCT02099669

Start date

Mar, 2014

Status verified date

Apr, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients with MDS ≥18 years of age
  • Transfusion dependent: at least 1 transfusion per month in the last 8 weeks
  • Hb <100g/L pre transfusion
  • Life expectancy > 6 months

Exclusion Criteria:

  • Unstable cardiac disease (Canadian Cardiovascular Society (CCS) III/IV angina or New York Heart Association (NYHA) III/IV congestive heart failure) requiring the transfusion target range to remain >85-100 g/L at all times
  • ECOG ≥3
  • Patients with red cell antibodies against high frequency antigens or multiple antibodies (would potentially delay finding blood)
  • Patients on ESA's or disease modifying agents (like azacitidine) for their MDS

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liberal transfusion strategy

Intervention: Red Blood Cell transfusions. Transfuse pRBC at a higher threshold- maintain Hb level between 110 and 120 g/L: to achieve this, 2 units of pRBCs are transfused when Hb level is < 105 g/L and 1 unit of RBCs when Hb level is 105-110 g/L.

Transfusions administered more frequently.

active comparator: Restrictive transfusion strategy

Intervention: Red Blood Cell transfusions. Transfuse pRBC at standard of care thresholds- maintain Hb level between 85 and 100 g/L: to achieve this, 2 units of packed red blood cells (pRBCs) will be transfused when the Hb level is < 80 g/L and 1 unit of pRBCs when Hb level is 80-85 g/L: standard administration

Interventions

Red Blood Cell Transfusions

Primary outcome measure

  • Percentage compliance of q2weekly hemoglobins [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada

Contacts

Principal Investigator:

Brian Leber, MD

Princess Margaret Hospital

Recruiting

Toronto, Canada

Sunnybrook Health Sciences Centre/Odette Cancer Centre

Recruiting

Toronto, Canada

Contacts

Principal Investigator:

Rena Buckstein

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 26, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2018-04-26.