A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery: The cryopreserved versus liquid platelet-New Zealand pilot trial. McGuinness, S., Charlewood, R., Gilder, E., Parke, R., Hayes, K., Morley, S., Al-Ibousi, A., Deans, R., Howe, B., Johnson, L., Marks, D. C., Reade, M. C., Australian, of Anaesthetists Clinical Trials Network, N. Z. C., Australian, & Group, N. Z. I. C. S. C. T. Vox Sanguinis, 117(3):337–345, March, 2022.
doi  abstract   bibtex   
BACKGROUND AND OBJECTIVES: Platelets for transfusion have a shelf-life of 7 days, limiting availability and leading to wastage. Cryopreservation at -80°C extends shelf-life to at least 1 year, but safety and effectiveness are uncertain. MATERIALS AND METHODS: This single centre blinded pilot trial enrolled adult cardiac surgery patients who were at high risk of platelet transfusion. If treating clinicians determined platelet transfusion was required, up to three units of either cryopreserved or liquid-stored platelets intraoperatively or during intensive care unit admission were administered. The primary outcome was protocol safety and feasibility. RESULTS: Over 13 months, 89 patients were randomized, 23 (25.8%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 h between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 103 /μl vs. 157 × 103 /μl, median difference 39.5 ×103 /μl, p = 0.03). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24-h blood loss, red cell transfusion or a composite bleeding outcome. CONCLUSION: This pilot randomized controlled trial demonstrated the feasibility of the protocol and adds to accumulating data supporting the safety of this intervention. Given the clear advantage of prolonged shelf-life, particularly for regional hospitals in New Zealand, a definitive non-inferiority phase III trial is warranted.
@article{mcguinness_pilot_2022,
	title = {A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery: {The} cryopreserved versus liquid platelet-{New} {Zealand} pilot trial},
	volume = {117},
	issn = {1423-0410},
	shorttitle = {A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery},
	doi = {10.1111/vox.13203},
	abstract = {BACKGROUND AND OBJECTIVES: Platelets for transfusion have a shelf-life of 7 days, limiting availability and leading to wastage. Cryopreservation at -80°C extends shelf-life to at least 1 year, but safety and effectiveness are uncertain.
MATERIALS AND METHODS: This single centre blinded pilot trial enrolled adult cardiac surgery patients who were at high risk of platelet transfusion. If treating clinicians determined platelet transfusion was required, up to three units of either cryopreserved or liquid-stored platelets intraoperatively or during intensive care unit admission were administered. The primary outcome was protocol safety and feasibility.
RESULTS: Over 13 months, 89 patients were randomized, 23 (25.8\%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 h between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 103 /μl vs. 157 × 103 /μl, median difference 39.5 ×103 /μl, p = 0.03). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24-h blood loss, red cell transfusion or a composite bleeding outcome.
CONCLUSION: This pilot randomized controlled trial demonstrated the feasibility of the protocol and adds to accumulating data supporting the safety of this intervention. Given the clear advantage of prolonged shelf-life, particularly for regional hospitals in New Zealand, a definitive non-inferiority phase III trial is warranted.},
	language = {eng},
	number = {3},
	journal = {Vox Sanguinis},
	author = {McGuinness, Shay and Charlewood, Richard and Gilder, Eileen and Parke, Rachael and Hayes, Katia and Morley, Sarah and Al-Ibousi, Aous and Deans, Renae and Howe, Belinda and Johnson, Lacey and Marks, Denese C. and Reade, Michael C. and {Australian and New Zealand College of Anaesthetists Clinical Trials Network} and {Australian and New Zealand Intensive Care Society Clinical Trials Group}},
	month = mar,
	year = {2022},
	pmid = {34581452},
	keywords = {Adult, Blood Platelets, Cardiac Surgical Procedures, Cryopreservation, Humans, New Zealand, Pilot Projects, Platelet Transfusion, blood transfusion, cardiac surgical procedures, cryopreservation, haemorrhage, platelet transfusion},
	pages = {337--345},
}
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