{"id":"W4401772749","doi":"10.1136/bmjopen-2024-091381","title":"Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial","year":2024,"lang":"en","type":"article","venue":"BMJ Open","topic":"Trauma, Hemostasis, Coagulopathy, Resuscitation","field":"Medicine","cited_by":8,"is_retracted":false,"has_abstract":true,"ca_institutions":"Women's College Hospital; University of Toronto; Queen's University; University Health Network","funders":"Canadian Institutes of Health Research; Octapharma; University of Toronto","keywords":"Medicine; Fresh frozen plasma; Prothrombin complex concentrate; Surgery; Clinical endpoint; Coagulation; Coagulation testing; Cardiac surgery; Factor VII; Coagulopathy; Anesthesia; Randomized controlled trial; Internal medicine; Warfarin; Atrial fibrillation; Platelet","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01736255,0.006237898,0.009380761,0.001333655,0.002962448,0.003581978,0.003148765,0.009327577,0.1126017],"category_scores_gemma":[0.0181281,0.0029881,0.004054682,0.001801188,0.003541616,0.002918819,0.00152631,0.01100544,0.02335017],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003670397,"about_ca_system_score_gemma":0.01151486,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001779933,"about_ca_topic_score_gemma":0.004634746,"domain_scores_codex":[0.9871683,0.007086707,0.001079052,0.001636734,0.001467912,0.001561342],"domain_scores_gemma":[0.9904673,0.002146463,0.002104697,0.001463837,0.001577476,0.002240364],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9260092,0.007393998,0.0005816645,0.009508231,0.001235382,0.0002945557,0.000227935,0.0008697246,0.002173933,0.003158909,0.02990322,0.01864328],"study_design_scores_gemma":[0.9328773,0.01901117,0.001406891,0.001605679,0.000506126,0.00008815616,0.00005643016,0.0008298325,0.0006641591,0.001936146,0.04092971,0.00008846693],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.002723012,0.0004777279,0.001176736,0.0004796141,0.001055296,0.9892397,0.002631472,0.0001589799,0.002057554],"genre_scores_gemma":[0.004505501,0.0002479997,0.001387784,0.0009635804,0.0002360572,0.9903813,0.0005984174,0.00001473553,0.001664557],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.1126017,"threshold_uncertainty_score":0.3766901,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2517817114396242,"score_gpt":0.4612164472286755,"score_spread":0.2094347357890513,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}