Efficacy of Prothrombin Complex Concentrate (PCC) for Reversal of Warfarin Effect.
Notice bibliographique
Résumé
Abstract In the United States supratherapeutic INRs are typically reversed with fresh frozen plasma (FFP). This requires transfusion of large volumes (10–15 ml/kg) with therapeutic delay, volume overload, risk for TRALI (transfusion related acute lung injury) and multiple donor exposures. Our Blood Utilization Review Committee recommends PCC as the preferred product for warfarin reversal. Profilnine (Alpha Therapeutic Corp, Los Angeles, CA) is PCC containing vitamin-K dependent clotting factors and dosed by FIX content. FII, VII and X content is no more than 150%, 35% and 100% of the FIX amount, respectively. The manufacturer’s suggested dose for warfarin reversal is 15–50 U/kg. The dose of PCC and need for vitamin K or FFP is determined by the clinician after consultation with the transfusion service. Sixty-five patients received PCC; 25 for reduction of INR prior to surgery or other interventions and 40 for treatment of a supratherapeutic INR (>5.0) with bleeding or risk of bleeding. Twenty-three patients with supratherapeutic INRs received low dose PCC (mean 25 U/kg) and 17 received high dose (mean 50 U/kg). The average admission INR was 9.0 (5.2–15.0) for the low-dose group and 8.6 (5.3–15) for the high-dose group. Repeat INR measurements occurred after PCC and again if FFP was transfused. Twenty patients had samples frozen for analysis of FII, VII, IX and X with a mean time between PCC infusion and sample draw of 2 hours (0.5–8.1). Ten of these were stable at the time of PCC infusion and were used to calculate relative factor recovery. The INR corrected (decreased to ≤3) in 55%(6/11) of cases following treatment with low-dose PCC, while high-dose PCC corrected the INR in 43%(3/7). Combination of PCC and FFP (mean 2 units, ~5–7 mL/kg) corrected the INR in 89% (16/18) and 87%(13/15) of cases for low and high-dose PCC, respectively. PCC dose, with or without FFP, had no effect on the likelihood of INR correction (Chi-square, p> 0.05). The addition of low dose FFP, however, significantly increased the response rate (Chi-square, p<0.05) for both doses. The average factor increment is summarized in Table 1. Differences in factor levels between the PCC and PCC plus FFP groups were not significant(ANOVA, p>0.05). Based on PCC dose the median recovery of factor IX was 100% with a median recovery for FII, VII and X of 168%, 32%, and 100% of the factor IX increment. When FFP was added to the treatment regimen the recovery of factor IX was 106% of the PCC dose. FII, VII, and X were 182%, 46%, and 119% of the FIX increment. Only FVII recovery was significantly higher in the PCC plus FFP group (Mann-Whitney, p< 0.05). In conclusion, treatment with Profilnine increases factor levels compatible with the manufacturer’s insert, but PCC plus FFP causes a larger FVII increment. Treatment with low or high dose PCC results in similar rates of INR correction. However, addition of FFP increases the rate of INR correction for both doses. Profilnine alone is, therefore, unable to reliably correct a supratherapeutic INR, and supplementation with small amounts of FFP is necessary to provide additional FVII. A PCC product with a higher content of FVII is a better therapeutic option but is not readily available in the United States. Factor increments following PCC infusion INR F II(%) F VII(%) F IX(%) F X(%) mean±SD PCC only Pre 8.3±4.5 11±10 7±7 10±10 6±3 Post 2.6±1.4 53±21 14±10 28±19 31±12 PCC plus FFP Pre 12.2±5.0 5±1 1±1 12±19 12±19 Post 1.9±0.8 76±28 20±12 45±22 53±19
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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 | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| 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 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».