Safety of prothrombin complex concentrate for emergency surgery according to the oral factor xa inhibitor level
Notice bibliographique
Résumé
Abstract Background: The incidence of thrombotic events after use of 4-factor prothrombin complex concentrate (4F-PCC) for oral factor Xa inhibitors-(XaI)-associated major bleeding is 3-4% and 5% in a study on 4F-PCC for XaI and emergency surgery. Rapid anti-Xa assays are seldom available, prompting clinicians to frequently administer 4F-PCC empirically. It is unknown if the thrombotic risk increases when pre-operative levels are low or unmeasured. Methods: We analyzed retrospectively all patients that received 4F-PCC between September 2018 and July 2024 at the hospitals in Hamilton, Canada, and screened for those with emergency surgery/invasive procedure as main indication. The PCC used was almost exclusively Octaplex (Octapharma). The primary outcomes were symptomatic or asymptomatic, objectively verified arterial or venous thromboembolism within 7 days from PCC infusion. The secondary outcome was the same but between day 8 and 30 postoperatively, at which timepoint other causes than preoperative PCC may be more prominent. XaI levels were determined with an anti-Xa assay, calibrated with the respective DOAC used by the patient. All-cause mortality within 30 days was also captured. The study was approved by Hamilton Integrated Research Ethics Board. Results: PCC at a median dose of 2000 units (interquartile range, 2000-2000) was administered to 224 patients on apixaban (142; 63%), rivaroxaban (71; 32%) or edoxaban (11;5%) for emergency surgery or invasive procedures. Mean age was 74 years and 42% were female. Postoperative prophylaxis against venous thromboembolism was started promptly in 184 patients (82%) after a median of 1 day (interquartile range, 1-2). Among 36 patients with high XaI levels, defined as at least 75 ng/mL there was 1 pulmonary embolism (3%); 24 patients with low levels had no events; 164 patients without any level measured had 7 events (4%) within 7 days, consisting of 5 myocardial infarctions, 1 DVT, 1 cerebral infarct. Two additional cerebral infarcts were deemed to be caused by compressive intracerebral hematomas that were evacuated. Events between day 8-30 were only in the group with no level – 3 deep vein thrombosis, 1 pulmonary embolism, 1 arterial thrombus. There were 8 deaths (22%) in the XaI high-level group, 2 (8%) in the low-level group, and 15 (9%) in the no-level group. Conclusion: The risk of thromboembolic events after 4F-PCC for management of hemostasis in patients on XaI and emergency surgery/invasive procedures appears to be similar among patients with preoperative drug levels that are high, low or not measured. These findings support the safe use of PCC in settings where rapid anti-Xa testing is unavailable.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».