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 (10 g/dL) Transfusion Strategy; Type: EXPERIMENTAL; Interventions: Biological: Liberal (10 g/dL) Transfusion Strategy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Restrictive (Symptomatic) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Liberal (10 g/dL) Transfusion Strategy; Assigned to Arm(s): Liberal (10 g/dL) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Restrictive (Symptomatic) Transfusion Strategy; Assigned to Arm(s): 2
B: 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
C: Arm Label: Restrictive transfusion strategy; Type: ACTIVE_COMPARATOR; Interventions: Other: Restrictive Transfusion Strategy | Arm Label: Liberal transfusion strategy; Type: ACTIVE_COMPARATOR; Interventions: Other: Liberal transfusion strategy | Intervention Type: OTHER; Name: Restrictive Transfusion Strategy; Assigned to Arm(s): Restrictive transfusion strategy | Intervention Type: OTHER; Name: Liberal transfusion strategy; Assigned to Arm(s): Liberal transfusion strategy
D: Arm Label: Restrictive arm (intervention); Type: EXPERIMENTAL; Interventions: Procedure: Less red blood cell transfusions | Arm Label: Standard care arm (comparator); Type: ACTIVE_COMPARATOR; Interventions: Procedure: More red blood cell transfusion (standard transfusion strategy in PICU) | Intervention Type: PROCEDURE; Name: Less red blood cell transfusions; Assigned to Arm(s): Restrictive arm (intervention) | Intervention Type: PROCEDURE; Name: More red blood cell transfusion (standard transfusion strategy in PICU); Assigned to Arm(s): Standard care arm (comparator)

Answer: B