Journal of clinical anesthesia · 2026
Trial Of Pathogen-reduced Cryoprecipitate vs. cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): a single center, prospective, cluster randomized trial in cardiovascular surgery.
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Cushing Melissa M, Cohen Tobias, Girardi Natalia I, Jimenez Alexandra, Andy Caroline, Milewski Andrew R, Fitzgerald Meghann M, Chen Dennis, Parra Priscilla, Rand Sophie, Sinfort Abraham, Lau Christopher, Keltner Nadia, Corash Laurence, Mack Charles, DeSimone Robert A
Аннотация
BACKGROUND: Low perioperative fibrinogen levels potentiate hemorrhage and increase transfusions in cardiac surgery patients. Cryoprecipitated anti-hemophilic factor (Cryo) requires on-demand thawing, often delaying fibrinogen supplementation; its short post-thaw shelf life limits pre-emptive availability. In contrast, Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR CRYO) can be stored post-thaw at room temperature for up to five days, allowing immediate availability without the need for on-demand thawing. This single-center, randomized trial compared PR CRYO to Cryo in cardiac surgery patients with suspected hypofibrinogenemia to determine whether PR CRYO reduces transfusions.
METHODS: Cryoprecipitate orders were cluster-randomized by month to PR CRYO or Cryo. Bleeding cardiac surgery patients receiving intraoperative cryoprecipitate were included. The primary outcome was number of allogeneic blood components transfused within 30 days. Multivariable mixed effects regression was used to evaluate outcomes.
RESULTS: The trial stopped early for futility after 170 of 502 planned patients (84 PR CRYO, 86 Cryo; conditional power 8.2%). Baseline characteristics were similar; valve/CABG procedures were most common (51%), followed by aneurysm (38%), and aortic arch repair (11%). Total blood component utilization was identical (6 units, IQR 3-12, both groups; p > 0.9). PR CRYO was issued 19 min faster (12 vs. 31 min; p < 0.001) and transfusion began 16 min sooner (46 vs. 62 min; p = 0.008). Adverse events and 3-day transfusions were similar.
CONCLUSIONS: PR CRYO was available earlier for bleeding patients in this first clinical trial of the product. No reduction in 30 day transfusions was demonstrated in this underpowered, single-center superiority trial. Safety and efficacy outcomes were numerically similar between groups; however, the trial was not designed to assess noninferiority, and therefore equivalence cannot be formally concluded.
METHODS: Cryoprecipitate orders were cluster-randomized by month to PR CRYO or Cryo. Bleeding cardiac surgery patients receiving intraoperative cryoprecipitate were included. The primary outcome was number of allogeneic blood components transfused within 30 days. Multivariable mixed effects regression was used to evaluate outcomes.
RESULTS: The trial stopped early for futility after 170 of 502 planned patients (84 PR CRYO, 86 Cryo; conditional power 8.2%). Baseline characteristics were similar; valve/CABG procedures were most common (51%), followed by aneurysm (38%), and aortic arch repair (11%). Total blood component utilization was identical (6 units, IQR 3-12, both groups; p > 0.9). PR CRYO was issued 19 min faster (12 vs. 31 min; p < 0.001) and transfusion began 16 min sooner (46 vs. 62 min; p = 0.008). Adverse events and 3-day transfusions were similar.
CONCLUSIONS: PR CRYO was available earlier for bleeding patients in this first clinical trial of the product. No reduction in 30 day transfusions was demonstrated in this underpowered, single-center superiority trial. Safety and efficacy outcomes were numerically similar between groups; however, the trial was not designed to assess noninferiority, and therefore equivalence cannot be formally concluded.