Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Red Blood Cell Transfusion Thresholds and QOL in MDS (EnhanceRBC): a Pilot, Feasibility Study
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.


Options:
A: Arm Label: Liberal Transfusion Strategy; Type: ACTIVE_COMPARATOR; Interventions: Biological: Red blood cell transfusion | Arm Label: Restrictive Transfusion Strategy; Type: ACTIVE_COMPARATOR; Interventions: Biological: Red blood cell transfusion | Intervention Type: BIOLOGICAL; Name: Red blood cell transfusion; Assigned to Arm(s): Liberal Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Red blood cell transfusion; Assigned to Arm(s): Restrictive Transfusion Strategy
B: Arm Label: Restrictive RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Restrictive RBC Transfusion | Arm Label: Liberal RBC Transfusion Group; Type: EXPERIMENTAL; Interventions: Biological: Liberal RBC Transfusion | Intervention Type: BIOLOGICAL; Name: Restrictive RBC Transfusion; Assigned to Arm(s): Restrictive RBC Transfusion Group | Intervention Type: BIOLOGICAL; Name: Liberal RBC Transfusion; Assigned to Arm(s): Liberal RBC Transfusion Group
C: Arm Label: Liberal transfusion strategy; Type: EXPERIMENTAL; Interventions: Other: Red Blood Cell Transfusions | Arm Label: Restrictive transfusion strategy; Type: ACTIVE_COMPARATOR; Interventions: Other: Red Blood Cell Transfusions | Intervention Type: OTHER; Name: Red Blood Cell Transfusions; Assigned to Arm(s): Liberal transfusion strategy, Restrictive transfusion strategy
D: Arm Label: Liberal RBC Transfusion Strategy; Type: EXPERIMENTAL; Interventions: Other: Liberal Red Blood Cell Transfusion Strategy | Arm Label: Restrictive RBC Transfusion Strategy; Type: ACTIVE_COMPARATOR; Interventions: Other: Restrictive Red Blood Cell Transfusion Strategy | Intervention Type: OTHER; Name: Liberal Red Blood Cell Transfusion Strategy; Assigned to Arm(s): Liberal RBC Transfusion Strategy | Intervention Type: OTHER; Name: Restrictive Red Blood Cell Transfusion Strategy; Assigned to Arm(s): Restrictive RBC Transfusion Strategy

Answer: C