1.
Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial
Stanworth SJ, Killick S, McQuilten ZK, Karakantza M, Weinkove R, Smethurst H, Pankhurst LA, Hodge RL, Hopkins V, Thomas HL, et al
British journal of haematology. 2020
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Abstract
Optimal red cell transfusion support in myelodysplastic syndromes (MDS) has not been tested and established. The aim of this study was to demonstrate feasibility of recruitment and follow-up in an outpatient setting with an exploratory assessment of quality of life (QoL) outcomes (EORTC QLQ-C30 and EQ-5D-5L). We randomised MDS patients to standardised transfusion algorithms comparing current restrictive transfusion thresholds (80 g/l, to maintain haemoglobin 85-100 g/l) with liberal thresholds (105 g/l, maintaining 110-125 g/l). The primary outcomes were measures of compliance to transfusion thresholds. Altogether 38 patients were randomised (n = 20 restrictive; n = 18 liberal) from 12 participating sites in UK, Australia and New Zealand. The compliance proportion for the intention-to-treat population was 86% (95% confidence interval 75-94%) and 99% (95-100%) for restrictive and liberal arms respectively. Mean pre-transfusion haemoglobin concentrations for restrictive and liberal arms were 80 g/l (SD6) and 97 g/l (SD7). The total number of red cell units transfused on study was 82 in the restrictive and 192 in the liberal arm. In an exploratory analysis, the five main QoL domains were improved for participants in the liberal compared to restrictive arm. Our findings support the feasibility and need for a definitive trial to evaluate the effect of different red cell transfusion thresholds on patient-centred outcomes.
PICO Summary
Population
Patients with myelodysplastic syndrome, (n=38).
Intervention
Restrictive transfusion threshold (80 g/l, to maintain haemoglobin 85-100 g/l), (n=20).
Comparison
Liberal transfusion threshold (105 g/l, to maintain haemoglobin 110-125 g/l), (n=18).
Outcome
The compliance proportion for the intention-to-treat population was 86% and 99% for restrictive and liberal arms respectively. Mean pre-transfusion haemoglobin concentrations for restrictive and liberal arms were 80 g/l (SD6) and 97 g/l (SD7). The total number of red cell units transfused on study was 82 in the restrictive and 192 in the liberal arm. In an exploratory analysis, the five main QoL domains were improved for participants in the liberal compared to restrictive arm.
2.
Design and preliminary results of a pilot randomized controlled trial on a 1:1:1 transfusion strategy: the trauma formula-driven versus laboratory-guided study
Nascimento B, Rizoli S, Rubenfeld G, Lin Y, Callum J, Tien HC
The Journal of Trauma. 2011;71((5, Suppl 1):):S418-26.
Abstract
BACKGROUND Retrospective reviews have recently shown an survival benefit for adopting a resuscitation strategy that transfuses plasma and platelets at a near 1:1 ratio with red blood cells (RBCs). However, a randomized controlled trial on the topic is lacking. We report on the design and preliminary results of our ongoing randomized control pilot trial (ClinicalTrial.gov NCT00945542). METHODS This is a 2-year feasibility randomized control trial at a single tertiary trauma center. Bleeding trauma patients were randomized to either a laboratory-driven or a formula-driven (1 plasma:1 platelet:1 RBC) transfusion protocols. Feasibility was assessed by analyzing for ability to enroll patients, appropriate activation of transfusion protocols, time to transfusion of each type of blood product, laboratory turnaround time, ratio of blood products transfused, and wastage of blood products. RESULTS From July 6, 2009, to May 31, 2010, n = 18 patients were randomized and included in the study. Issues that we noted were the need to do postrandomization exclusions, the need to have rapid and accurate predictors of massive bleeding to enroll patients quickly, and the need to have waived consent for study participation. As well, we noted that the logistics of administering 1:1:1 were formidable and required rapid access to thawed plasma. Similarly, challenges in the control arm of such a study included the turnaround time for obtaining laboratory results. CONCLUSION Despite major challenges, our initial experience suggests that with an organized system, it is possible to prospectively randomize massively bleeding trauma patients. The accomplishment of high ratios of plasma to RBCs is challenging with current thawing methods and unavailability of thawed plasma in Canada. Longer shelf-life for plasma and faster plasma thawing microwaves should overcome some of these obstacles. For a laboratory-guided transfusion protocol, massive transfusion protocols should be in place with faster turnaround time for coagulation tests. Finally, further research on predictors of massive transfusion is needed.