Cardiothoracic & vascular anaesthesia
Trial Of Pathogen-reduced Cryoprecipitate vs. cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): a single center, prospective, cluster randomized trial in cardiovascular surgery
Authors' conclusion
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.
Study context
- Population
- Bleeding cardiac surgery patients receiving intraoperative cryoprecipitate, with suspected hypofibrinogenemiaof 502 planned patients, trial stopped early for futility · PR CRYO 84 · Cryo 86
- Participants
- 170 patients
- Comparison
- PR CRYO vs Cryo
- PR CRYOn = 84
- Cryon = 86
- Primary endpoint
- Number of allogeneic blood components transfused
- Follow-up
- Within 30 days
Methodological detailscluster-randomized by month, superiority trial
- Cluster-randomized by month
- Superiority trial
Primary result
As reported in the abstract
- PR CRYO vs Cryo: P > 0.9
- Total blood component utilization; 6 units, IQR 3-12, both groups
Further findings
Time to issue
difference (faster with PR CRYO) 19 min · P < 0.001
Time to transfusion start
difference (sooner with PR CRYO) 16 min · P = 0.008
3-day transfusions
- Similar between groups
Early stop for futility
- Conditional power
- 8.2%
- Patients enrolled of planned
- 170 of 502
- Trial stopped early for futility
Procedure types
- valve/CABG
- 51%
- Aneurysm
- 38%
- Aortic arch repair
- 11%
- Baseline characteristics were similar
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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