Fresh Red Cells for Transfusion in Critically Ill Adults: An Economic Evaluation of the Standard Issue Transfusion versus Fresher Red-Cell Use in Intensive Care (TRANSFUSE) Clinical Trial
Irving A, Higgins A, Ady B, Bellomo R, Cooper DJ, French C, Gantner D, Harris A, Irving DO, Murray L, et al
Critical care medicine. 2019
OBJECTIVES Trials comparing the effects of transfusing RBC units of different storage durations have considered mortality or morbidity as outcomes. We perform the first economic evaluation alongside a full age of blood clinical trial with a large population assessing the impact of RBC storage duration on quality-of-life and costs in critically ill adults. DESIGN Quality-of-life was measured at 6 months post randomization using the EuroQol 5-dimension 3-level instrument. The economic evaluation considers quality-adjusted life year and cost implications from randomization to 6 months. A generalized linear model was used to estimate incremental costs (2016 U.S. dollars) and quality-adjusted life years, respectively while adjusting for baseline characteristics. SETTING Fifty-nine ICUs in five countries. PATIENTS Adults with an anticipated ICU stay of at least 24 hours when the decision had been made to transfuse at least one RBC unit. INTERVENTIONS Patients were randomized to receive either the freshest or oldest available compatible RBC units (standard practice) in the hospital transfusion service. MEASUREMENTS AND MAIN RESULTS EuroQol 5-dimension 3-level utility scores were similar at 6 months-0.65 in the short-term and 0.63 in the long-term storage group (difference, 0.02; 95% CI, -0.00 to 0.04; p = 0.10). There were no significant differences in resource use between the two groups apart from 3.0 fewer hospital readmission days (95% CI, -5.3 to -0.8; p = 0.01) during follow-up in the short-term storage group. There were no significant differences in adjusted total costs or quality-adjusted life years between the short- and long-term storage groups (incremental costs, -$2,358; 95% CI, -$5,586 to $711) and incremental quality-adjusted life years: 0.003 quality-adjusted life years (95% CI, -0.003 to 0.008). CONCLUSIONS Without considering the additional supply cost of implementing a freshest available RBC strategy for critical care patients, there is no evidence to suggest that the policy improves quality-of-life or reduces other costs compared with standard transfusion practice.
A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial
Reade MC, Marks DC, Bellomo R, Deans R, Faulke DJ, Fraser JF, Gattas DJ, Holley AD, Irving DO, Johnson L, et al
BACKGROUND Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval. STUDY DESIGN AND METHODS The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought. RESULTS A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group. CONCLUSION In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.
Age of red cells for transfusion and outcomes in critically ill adults
Cooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, et al
The New England Journal of Medicine. 2017;377((19):):1858-1867
Background It is uncertain whether the duration of red-cell storage affects mortality after transfusion among critically ill adults. Methods In an international, multicenter, randomized, double-blind trial, we assigned critically ill adults to receive either the freshest available, compatible, allogeneic red cells (short-term storage group) or standard-issue (oldest available), compatible, allogeneic red cells (long-term storage group). The primary outcome was 90-day mortality. Results From November 2012 through December 2016, at 59 centers in five countries, 4994 patients underwent randomization and 4919 (98.5%) were included in the primary analysis. Among the 2457 patients in the short-term storage group, the mean storage duration was 11.8 days. Among the 2462 patients in the long-term storage group, the mean storage duration was 22.4 days. At 90 days, there were 610 deaths (24.8%) in the short-term storage group and 594 (24.1%) in the long-term storage group (absolute risk difference, 0.7 percentage points; 95% confidence interval [CI], -1.7 to 3.1; P=0.57). At 180 days, the absolute risk difference was 0.4 percentage points (95% CI, -2.1 to 3.0; P=0.75). Most of the prespecified secondary measures showed no significant between-group differences in outcome. Conclusions The age of transfused red cells did not affect 90-day mortality among critically ill adults. (Funded by the Australian National Health and Medical Research Council and others; TRANSFUSE Australian and New Zealand Clinical Trials Registry number, ACTRN12612000453886 ; ClinicalTrials.gov number, NCT01638416 .).
Determining the effect of vein visualization technology on donation success, vasovagal symptoms, anxiety and intention to re-donate in whole blood donors aged 18-30 years: a randomized controlled trial
Waller D, Mondy P, Brama T, Fisher J, King A, Malkov K, Wall-Smith D, Ryan L, Irving DO
Vox Sanguinis. 2016;111((2):):135-43
BACKGROUND AND OBJECTIVES Vein visualization technology (VVT) devices use near-infrared light to assist location of peripheral veins. The current study investigated the impact of VVT on donor experience and collection success for young blood donors at the Australian Red Cross Blood Service. MATERIALS AND METHODS The study in donors aged 18 to 30 years used a two intervention to one control randomized trial design with 285 new and 587 returning donors recruited at two sites. Donors reported presyncopal symptoms, phlebotomy pain, anxiety and intentions to redonate along with other measures. Participating phlebotomists rated usefulness of the technology. Flow rates, collection volumes and other donation information were taken from routine data. RESULTS No significant differences were found between control and intervention groups on presyncopal symptoms, phlebotomy pain, anxiety, intentions to redonate, flow rates, collection volumes or vasovagal reactions (all P's > 0.05). Phlebotomist ratings of VVT were significantly more positive when they had less than 5 years of experience (P < 0.01) or when the vein was not visible to the naked eye (P < 0.01). CONCLUSIONS Results suggest that VVT does not improve the donation experience for younger blood donors. Staff reports indicate that VVT may have some utility for assisting with difficult phlebotomies.
Vein visualisation technology and young blood donors: impact on donation success and retention
Waller D, Mondy P, Brama T, Wall-Smith D, Irving DO, Fisher J, King A, Malkov K, Diaz P, Shuttleworth G, et al
Vox Sanguinis. 2015;109((Suppl. 1)):138-139.. Abstract No. P-170.
Frozen platelets for rural Australia: the CLIP trial
Reade MC, Marks DC, Johnson L, Irving DO, Holley AD
Anaesthesia & Intensive Care. 2013;41((6):):804-5.