Efecto de las diferentes drogas anticoagulantes sobre el ensayo de fibrinógeno derivado del tiempo de protrombina / Effect of different anticoagulant drugs on the prothrombin time-derived fibrinogen assay

Resumen El objetivo de este trabajo fue comparar los niveles de fibrinógeno (FBG) obtenidos por el método de Clauss con los obtenidos por el método de fibrinógeno derivado del tiempo de protrombina (FBG PT-d), con dos tromboplastinas, en pacientes anticoagulados con distintas drogas. Se estudiaron pacientes anticoagulados consecutivos: 105 con antagonistas de la vitamina K (AVK), 55 con heparina no fraccionada (HNF), 58 con heparina de bajo peso molecular (HBPM), 60 con rivaroxabán, 45 con apixabán, 60 con dabigatrán y 100 controles normales (CN). El FBG se determinó por el método de Clauss y FBG PT-d utilizando tromboplastina de cerebro de conejo o recombinante humana; los niveles de heparina, rivaroxabán y apixabán por método cromogénico anti Xa; el dabigatrán con el ensayo de tiempo de trombina diluido. Existió un sesgo positivo (p<0,001) al comparar el FBG PT-d vs. FBG por Clauss: CN: 13,7%, AVK: 31,8%, rivaroxabán: 34,8% y apixabán: 20,0% cuando se utilizó tromboplastina de conejo. En el caso de las muestras que contenían HBPM se observó este desvío con ambas tromboplastinas. El sesgo porcentual en presencia de dabigatrán y heparina no fraccionada no fue estadísticamente distinto del obtenido en el grupo control. El ensayo de FBG PT-d no debe utilizarse en pacientes anticoagulados con rivaroxabán, apixabán, HBPM o AVK, ya que sobreestima los niveles de FBG. El porcentaje de sesgo depende del tipo de tromboplastina utilizado y fue mayor con la de cerebro de conejo en el sistema de detección utilizado.

Abstract The aim of this study was to compare fibrinogen (FBG) results obtained by Clauss method (FBG-C) and by the prothrombin time-derived fibrinogen assay (FBG PT-d) with two thromboplastins in patients under anticoagulation. Consecutive anticoagulated patients were studied: 105 vitamin-K antagonist (VKA), 55 unfractioned heparin, 58 LMWH, 60 rivaroxaban, 45 apixaban and 60 dabigatran, and 100 healthy controls (NC). FBG-C was performed by Clauss and FIB PT-d with rabbit brain and human recombinant thromboplastins, respectively. Heparins, rivaroxaban and apixaban levels were measured by antiXa; dabigatran by thrombin diluted assay. A positive bias of FBG PT-d vs. FBG-C with both thromboplastins were seen in NC (13.7 and 19.0 % for HS and RP, respectively), but bias with HS in rivaroxaban, apixaban and VKA patients were significantly higher compared to NC: 34.8%, 20.0 % and 31.8 %, respectively. LMWH presented higher BIAS compared to NC with both thromboplastins. Samples with unfraction heparin and dabigatran presented similar bias to NC. FBG PT-d should not be used in patients under anticoagulant treatment because of an important overestimation of FBG could be obtained in these patients. The percentage of bias depends on the type of thromboplastin used; it was higher with rabbit brain thromboplastin in the detection system used.

Resumo O objetivo deste trabalho foi comparar os níveis de fibrinogênio (FBG) obtidos pelo método de Clauss com aqueles obtidos pelo método do fibrinogênio derivado do tempo de protrombina (FBG PT-d), com duas tromboplastinas, em pacientes anticoagulados com diferentes drogas. Pacientes anticoagulados consecutivos foram estudados: 105 com antagonista da vitamina K (AVK); 55 com heparina não fracionada (UFH); 58 com heparina de baixo peso molecular (HBPM), 60 com rivaroxabana, 45 com apixabana, 60 com dabigatrana e 100 controles normais (CN). FBG foi determinado pelo método de Clauss e FBG PT-d usando tromboplastina de cérebro de coelho ou tromboplastina humana recombinante; níveis de heparina, rivaroxabana e apixabana pelo método cromogênico anti-Xa; dabigatrana com ensaio de tempo de trombina diluída. Há um viés positivo (p<0,001) ao comparar o FBG PT-d vs FBG de Clauss: CN: 13,7%; AVK: 31,8%, rivaroxabana: 34,8% e apixabana 20,0% quando foi utilizada tromboplastina de coelho. No caso das amostras contendo HBPM, esse desvio foi observado com ambas as tromboplastinas. O viés percentual na presença de dabigatrana e heparina não fracionada não foi estatisticamente diferente daquela obtida no grupo controle. O ensaio de FBG PT-d não deve ser usado em pacientes anticoagulados com rivaroxabana, apixabana, LMWH ou VKA, pois superestima os níveis de FBG. A porcentagem de viés depende do tipo de tromboplastina utilizado e foi maior com a de cérebro de coelho, no sistema de detecção utilizado.

Comparison of matched sibling, unrelated and haploidentical donors in hematopoietic stem cell transplantation. A real world experience from the Argentine Group For Bone Marrow Transplantation And Cell Therapy (GATMO-TC) / Comparación de donantes relacionados, no relacionados y haploidénticos en trasplante de progenitores hematopoyéticos. Experiencia del Grupo Argentino de Trasplante de Médula Ósea y Terapia Celular (GATMO-TC)

Abstract We retrospectively analyzed 570 adult patients who received allogeneic stem cell transplantation for malignant diseases. The outcomes were compared according to donor type. Most of the patients (60%) were transplanted for acute leukemia. Median follow-up was 1.6 years. Haploidentical allogeneic stem cell transplantation was more frequently performed for acute myeloid leukemia and in late stages than any other donor type. Non-relapse mortality at 100 days and one year for unrelated and haploidentical donors were similar, 19%-29% vs. 17%-28%, respectively. A significant better non-relapse mortality was observed for matched sibling donors (7%-15%; p < 0.001). Relapse rate was higher in haploidentical donors compared to matched sibling and unrelated donors (three year relapse rate 46%, 39%, 28%; respectively p < 0.001). Haploidentical donors resulted in lower three year progression-free survival and worse 3 year overall survival (32%; p < 0.001 and 42%; p < 0.001) compared with other donors (44% and 55% MSD, 40% and 42% UD, respectively). The incidence of grade II-IV acute graft-versus-host disease was higher in unrelated donors (51% unrelated, 35% haploidentical, 36% matched sibling; respectively; p = 0.001), with no difference in grades III-IV (p = 0.73) or in chronic graft-versus-host disease (p = 0.2) between groups. After multivariate analysis, haploidentical and unrelated donors remained negatively associated with non-relapse mortality (HR 1.95; 95% CI 1.10-3.20 and HR 2.70; 95% CI 1.63-4.46, respectively). Haploidentical donors were associated with a higher risk of relapse and worse overall survival. This analysis shows that haploidentical donors were associated with similar non-relpase mortality and higher relapse rates than unrelated donors. Better results in non-relapse mortality were observed for matched sibling donors.

Resumen Se efectuó un análisis retrospectivo de 570 pacientes adultos que recibieron un trasplante alogénico de precursores hematopoyéticos, comparando los resultados según el tipo de donante. La mediana de seguimiento fue de 1.6 años. El 60% de la población se trasplantó por leucemias agudas. Los trasplantes haploidénticos se hicieron en su mayoría en leucemia mieloide aguda y en estadios tardíos en comparación a otros donantes. La mortalidad libre de enfermedad al día +100 y a 1 año fue similar para los donantes no emparentados y haploidénticos (19% y 29% vs. 17% y 28%, respectivamente). Se obtuvieron mejores resultados con donantes relacionados idénticos (7% y 15%; p < 0.001). La recaída fue mayor en los donantes haploidénticos (tres años 46% haploidénticos, 39% relacionados idénticos, 28% no emparentados; p < 0.003). El trasplante con donante haploidéntico presentó una menor supervivencia libre de progresión y menor supervivencia global a tres años (32%; p < 0.001 y 42%; p < 0.001). La incidencia de enfermedad injerto contra huésped aguda fue mayor en no emparentados (51%, 35% haploidénticos, 36% relacionados idénticos; p = 0.001), sin diferencias en grados III-IV (p = 0.73) o en EICH crónica (p = 0.2). Los trasplantes con donante haploidéntico y no emparentado mantuvieron su asociación negativa con mortalidad libre de enfermedad (HR 1.95; 95%IC 1.10-3.20 y HR 2.70; 95%IC 1.63-4.46), en análisis multivariado. El trasplante haploidéntico se asoció a mayor recaída y a menor supervivencia global. Esta experiencia mostró similar mortalidad libre de enfermedad entre trasplantes con donantes haploidénticos y no emparentados. Los trasplantes relacionados idénticos mostraron menores tasas de mortalidad libre de enfermedad.

Comparison of matched sibling, unrelated and haploidentical donors in hematopoietic stem cell transplantation. A real-world experience from the Argentine Group for Bone Marrow Transplantation and Cell Therapy (GATMO-TC).

We retrospectively analyzed 570 adult patients who received allogeneic stem cell transplantation for malignant diseases. The outcomes were compared according to donor type. Most of the patients (60%) were transplanted for acute leukemia. Median follow-up was 1.6 years. Haploidentical allogeneic stem cell transplantation was more frequently performed for acute myeloid leukemia and in late stages than any other donor type. Non-relapse mortality at 100 days and one year for unrelated and haploidentical donors were similar, 19%-29% vs. 17%-28%, respectively. A significant better non-relapse mortality was observed for matched sibling donors (7%-15%; p < 0.001). Relapse rate was higher in haploidentical donors compared to matched sibling and unrelated donors (three year relapse rate 46%, 39%, 28%; respectively p < 0.001). Haploidentical donors resulted in lower three year progression-free survival and worse 3 year overall survival (32%; p < 0.001 and 42%; p < 0.001) compared with other donors (44% and 55% MSD, 40% and 42% UD, respectively). The incidence of grade II-IV acute graft-versus-host disease was higher in unrelated donors (51% unrelated, 35% haploidentical, 36% matched sibling; respectively; p = 0.001), with no difference in grades III-IV (p = 0.73) or in chronic graft-versus-host disease (p = 0.2) between groups. After multivariate analysis, haploidentical and unrelated donors remained negatively associated with non-relapse mortality (HR 1.95; 95% CI 1.10-3.20 and HR 2.70; 95% CI 1.63-4.46, respectively). Haploidentical donors were associated with a higher risk of relapse and worse overall survival. This analysis shows that haploidentical donors were associated with similar non-relpase mortality and higher relapse rates than unrelated donors. Better results in non-relapse mortality were observed for matched sibling donors.

Se efectuó un análisis retrospectivo de 570 pacientes adultos que recibieron un trasplante alogénico de precursores hematopoyéticos, comparando los resultados según el tipo de donante. La mediana de seguimiento fue de 1.6 años. El 60% de la población se trasplantó por leucemias agudas. Los trasplantes haploidénticos se hicieron en su mayoría en leucemia mieloide aguda y en estadios tardíos en comparación a otros donantes. La mortalidad libre de enfermedad al día +100 y a 1 año fue similar para los donantes no emparentados y haploidénticos (19% y 29% vs. 17% y 28%, respectivamente). Se obtuvieron mejores resultados con donantes relacionados idénticos (7% y 15%; p < 0.001). La recaída fue mayor en los donantes haploidénticos (tres años 46% haploidénticos, 39% relacionados idénticos, 28% no emparentados; p < 0.003). El trasplante con donante haploidéntico presentó una menor supervivencia libre de progresión y menor supervivencia global a tres años (32%; p < 0.001 y 42%; p < 0.001). La incidencia de enfermedad injerto contra huésped aguda fue mayor en no emparentados (51%, 35% haploidénticos, 36% relacionados idénticos; p = 0.001), sin diferencias en grados III-IV (p = 0.73) o en EICH crónica (p = 0.2). Los trasplantes con donante haploidéntico y no emparentado mantuvieron su asociación negativa con mortalidad libre de enfermedad (HR 1.95; 95%IC 1.10-3.20 y HR 2.70; 95%IC 1.63-4.46), en análisis multivariado. El trasplante haploidéntico se asoció a mayor recaída y a menor supervivencia global. Esta experiencia mostró similar mortalidad libre de enfermedad entre trasplantes con donantes haploidénticos y no emparentados. Los trasplantes relacionados idénticos mostraron menores tasas de mortalidad libre de enfermedad.

Predicting Mortality after Autologous Transplant: Development of a Novel Risk Score.

There have been several efforts to predict mortality after autologous stem cell transplantation (ASCT), such as the hematopoietic cell transplant-comorbidity index (HCT-CI), described for allogeneic stem cell transplantation and validated for ASCT, but there is no composite score in the setting of ASCT combining comorbidities with other clinical characteristics. Our aim is to describe a comprehensive score combining comorbidities with other clinical factors and to analyze the impact of this score on nonrelapse mortality (NRM), overall survival (OS), and early morbidity endpoints (mechanical ventilation, shock or dialysis) after ASCT. For the training cohort, we retrospectively reviewed data of 2068 adult patients who received an ASCT in Argentina (October 2002 to June 2017) for multiple myeloma or lymphoma. For the validation cohort, we analyzed 2168 ASCTs performed in the Medical College of Wisconsin and Spanish stem cell transplant group (Grupo Español de Trasplante Hematopoyético (GETH)) (January 2012 to December 2018). We first performed a multivariate analysis for NRM in order to select and assign weight to the risk factors included in the score (male patients, aged 55 to 64 and ≥65 years, HCT-CI ≥3, Hodgkin lymphoma and non-Hodgkin lymphoma). The hazard ratio for NRM increased proportionally with the score. Patients were grouped as low risk (LR) with a score of 0 to 1 (686, 33%), intermediate risk (IR) with a score of 2 to 3 (1109, 53%), high risk (HR) with a score of 4 (198, 10%), and very high risk (VHR) with a score of ≥5 (75, 4%). The score was associated with a progressive increase in all the early morbidity endpoints. Moreover, the score was significantly associated with early NRM (day 100: 1.5% versus 2.4% versus 7.6% versus 17.6%) as well as long term (1 to 3 years; 1.8% to 2.3% versus 3.8% to 4.9% versus 11.7% to 14.5% versus 25.0% to 27.4%, respectively; P< .0001) and OS (1 to 5 years; 94% to 73% versus 89% to 75% versus 76% to 47% versus 65% to 52% respectively; P < .0001). The score was validated in an independent cohort (N = 2168) and was significantly associated with early and late events. In conclusion, we developed and validated a novel score predicting NRM and OS in 2 large cohorts of more than 2000 autologous transplant patients. This tool can be useful for tailoring conditioning regimens or defining risk for transplant program decision making.

Haploidentical transplant in adult patients with acute lymphoblastic leukemia in Argentina: a comparison with matched related and unrelated donors.

We aimed at analyzing the outcome of allogeneic stem cell transplant (ASCT) in adult patients with acute lymphoblastic leukemia (ALL), comparing Haploidentical (Haplo) with HLA-matched (sibling and unrelated) donors. Between 2008 and 2017, we collected data from 236 patients (median age 31 years; range 16-64; 90% HCT-CI 0-1) who underwent unmanipulated ASCT in first complete remission and subsequent remissions in 15 Argentinian centers. Donors were HLA-matched (n = 175; 74%) and Haplo (n = 61; 26%). Two-year overall survival (OS) was 55% (95% CI 47-63) for the HLA-matched group and 49% (95% CI 34-62) for the Haplo group (p = 0.351). For OS, crude HR, adjusted HR for covariates (HR 1.24; 95% CI 0.77-1.99; p = 0.363) and HR including a propensity score in the model (HR 1.22; 95% CI 0.71-2.08; p = 0.414) showed no impact of donor category on the OS. No difference was found in terms of nonrelapse mortality, relapse, leukemia-free survival, and grade 3-4 acute graft-versus-host disease (GVHD); 2-year incidence of chronic GVHD was higher in HLA-matched vs Haplo group (p = 0.028). Patients with ALL who underwent ASCT were young subjects with low HCT-CI. In this setting, a Haplo donor represents an alternative widely available in the absence of an HLA-matched donor. Relapse remains a challenge for all donor categories.

Utilización de un dispositivo portátil para monitorear la relación internacional normalizada en pacientes con anticoagulante lúpico positivo / Use of a portable device to monitor the international normalized ratio in patients with positive lupus anticoagulant

La certeza del valor de la relación internacional normalizada (RIN), ensayo para controlar la anticoagulación con dicumarínicos, en pacientes con anticoagulante lúpico positivo (AL) es desconocida especialmente para los dispositivos al lado del paciente (POCT). El objetivo de este trabajo fue investigar si existe correlación entre el valor del RIN obtenido por el método tradicional y el obtenido con un dispositivo portátil en pacientes con AL positivo. Se estudiaron 35 pacientes anticoagulados por enfermedad tromboembólica con diagnóstico de AL positivo persistente a los que se les determinó al mismo tiempo el RIN por el método tradicional y con CoaguChek durante 4 controles consecutivos. El rango del RIN fue 1,9 a 5,60 y el RIN-POCT estuvo entre 2,0 y 4,92. La comparación del RIN vs RIN-POCT mostró r=0,98, pendiente: 1,56 (0,98-1,12) y una ordenada al origen de -0,088 (-0,282-0,007). El sesgo fue 2,1%. Para un nivel del RIN menor de 3,5 (n=136 controles) la diferencia del RIN promedio fue de 0,17 con un rango de 0,01-0,56. Un paciente, con triple positividad, mostró una diferencia entre ambos métodos mayor de 0,4 en dos controles. Para un RIN mayor de 4,5 el grado de concordancia fue menor pero no tiene implicancia clínica. Los resultados del RIN obtenidos por CoaguChek en los pacientes estudiados con AL positivo son útiles para la práctica clínica. Los datos obtenidos demuestran que hay una buena correlación entre el RIN tradicional y el CoaguChek. Por la gran diversidad de los equipos POCT los resultados no son extrapolables a otros dispositivos. Dada la heterogeneidad de los anticuerpos antifosfolípidos, es recomendable probar en cada paciente si hay una buena concordancia entre el RIN tradicional y el RIN-POCT.

The certainty of the value of the international normalized relation (INR) assay to control dicoumarin anticoagulation in patients with positive lupus anticoagulant (LA) is unknown especially for the point of care testing (POCT). The aim of this work was to investigate if there was a correlation between the INR values obtained by the traditional method and those obtained with a POCT in patients with positive LA. The population under study were 35 patients anticoagulated by thromboembolic disease with a persistent positive LA, whose INR was determined at the same time by the traditional method and with CoaguChek during 4 consecutive controls. The INR range was 1.9 to 5.60 and the RIN-POCT was between 2.0-4.92. The comparison of INR vs. INR - POCT showed r=0.98, slope: 1.56 (0.98-1.12) and ordered to the origin -0.088 (-0.282-0.007). The bias was 2.1%. For an INR level lower than 3.5 (n=136 controls) the average INR difference was 0.17 with a range of 0.01-0.56. One patient, with triple positivity showed a difference between both methods greater than 0.4. in two controls. For INR greater than 4.5, the degree of concordance is lower but has no clinical implications. The data obtained show that there is a good correlation between the traditional INR and the CoaguChek. The results of INR obtained by CoaguChek in patients studied with positive LA are useful for clinical practice. Due to the large diversity of POCT, the results cannot be extrapolated to other devices. Given the heterogeneity of antiphospholipid antibodies, it is advisable to test in each patient whether there is a good agreement between the traditional INR and INR-POCT.

A certeza do valor da razão internacional normalizada (RIN ou IIN), ensaio que controla a anticoagulação com dicumarínicos, em pacientes com anticoagulante lúpico positivo (AL) é desconhecida especialmente para os dispositivos de teste do tipo point-of-care (POCT). Este trabalho teve como objetivo pesquisar se existe correlação entre o valor de RIN obtido pelo método tradicional e aquele obtido com um dispositivo portátil em pacientes com AL positivo. Foram estudados 35 pacientes anticoagulados por doença tromboembólica com diagnóstico de AL positivo persistente aos quais lhes determinaram, ao mesmo tempo, a RIN pelo método tradicional e com CoaguChek durante 4 controles consecutivos. O intervalo de RIN foi de 1,9 a 5,60 e o de RIN-POCT ficou entre 2,0 e 4,92. A comparação de RIN vs RIN-POCT mostrou r=0,98, pendente: 1,56 (0,98-1,12) e uma ordenada à origem de -0,088 (-0,282-0,007). O viés foi 2,1%. Para um nível de RIN menor a 3,5 (n=136 controles) a diferença de RIN em média foi de 0,17 com um intervalo de 0,01-0,56. Um paciente, com tríplice positividade, mostrou uma diferença entre ambos os métodos maior a 0,4 em dois controles. Para um RIN de mais de 4,5, o grau de concordância foi menor, mas não tem consequências clínicas. Nos pacientes estudados com AL positivo, os resultados da RIN obtidos por CoaguChek são úteis para a prática clínica. Os dados obtidos demonstram que existe uma boa correlação entre a RIN tradicional e o CoaguChek. Devido à grande diversidade dos equipamentos POCT, os resultados não são extrapoláveis a outros dispositivos. É recomendável, visto a heterogeneidade dos anticorpos antifosfolípídes, provar em cada paciente a existência de uma boa concordância entre a RIN tradicional e a RIN-POCT.

Hematopoietic Cell Transplantation-Specific Comorbidity Index Predicts Morbidity and Mortality in Autologous Stem Cell Transplantation.

The hematopoietic cell transplantation-specific comorbidity index (HCT-CI) score is a useful tool to assess the risk for nonrelapse mortality (NRM) after allogeneic hematopoietic stem cell transplantation. Although the HCT-CI has been investigated in autologous stem cell transplantation (ASCT), its use is limited. To improve on the current use of the HCT-CI score on the morbidity and mortality after ASCT, we assessed the 100-day morbidity defined as orotracheal intubation (OTI), dialysis or shock (vasopressors need), 100-day NRM, early composite morbidity-mortality (combined endpoint that included any previous endpoints), and long-term NRM. We retrospectively reviewed a cohort of 1730 records of adult patients who received an ASCT in Argentinean center's between October 2002 and August 2016. Median follow-up was 1.15 years, and median age was 53 years. Diseases were multiple myeloma (48%), non-Hodgkin lymphoma (27%), and Hodgkin lymphoma (17%); 51% were in complete or partial remission; and 13% received ≥ 3 chemotherapy lines before transplant (heavily pretreated). Early NRM (100-day) was 2.7%, 5.4% required OTI, 4.5% required vasopressors, and 2.1% dialysis, with an early composite morbidity-mortality of 6.8%. Long-term (1 and 3 years) NRM was 4% and 5.2% and overall survival 89% and 77%, respectively. High-risk HCT-CI patients had a significant increase in 100-day NRM compared with intermediate and low risk (6.1% versus 3.4% versus 1.8%, respectively; P = .002), OTI (11% versus 6% versus 4%, P = .001), shock (8.7% versus 5.8% versus 3%, P = .001), early composite morbidity-mortality (13% versus 9 % versus 4.7%, P < .001), and long-term NRM (1 year, 7.7% versus 4% versus 3.3%; and 3 years, 10.8% versus 4% versus 4.8%, respectively; P = .002). After multivariate analysis these outcomes remained significant: early composite morbidity-mortality (odds ratio [95% confidence interval] compared with low risk: intermediate risk 2.1 [1.3 to 3.5] and high risk 3.3 [1.9 to 5.9]) and NRM (hazard ratio [95% confidence interval] compared with low risk: intermediate risk .97 [.8 to 2.4] and high risk 3.05 [1.3 to 4.5]). No significant impact was observed in overall survival. Other than comorbidities, significant impact was observed for heavily pretreated patients, age ≥ 55 years, non-Hodgkin lymphoma, and bendamustine-etoposide-citarabine-melphalan conditioning. We confirmed that the HCT-CI had a significant impact on NRM after ASCT, and these findings are mainly due to early toxicity express as 100-day NRM and the 3 main morbidity outcomes as well as the composite endpoint.

Comparación de la detección foto óptica vs. electromecánica del coágulo / Comparison of mechanical vs. optical clot detection / Comparação da detecção foto-óptica vs. eletromecânica do coágulo

El objetivo de este estudio fue determinar si la detección foto óptica del coágulo es equivalente a la detección electromecánica al realizar el tiempo de protrombina (TP), el tiempo de tromboplastina parcial activado (APTT) y el dosaje de fibrinógeno (FBG). Se estudiaron 258 pacientes consecutivos que concurrieron al laboratorio para realizar estudios de hemostasia. Se utilizaron tres coagulómetros: ACL TOP (foto-óptico) y STArt y Destiny plus como detección electro mecánica. EL TP, APTT y FBG fueron realizados en todos los equipos antes de transcurridas tres horas de la toma de la muestra. Se obtuvo una buena correlación entre los resultados obtenidos con ambos métodos de detección TP (%): (ACL TOP vs. STArt R=0,989; ACL TOP vs. Destiny plus R=0,988), APTT: (ACL TOP vs. STArt R=0,938; ACL TOP vs. Destiny Plus R=0,989), y FBG (ACL TOP vs. STArt R=0,97; ACL TOP vs. Destiny Plus R=0,984). La diferencia de los resultados entre plataformas son menores al error total permitido establecido por los criterios de CLIA (ETa TP y APTT =15% y FBG 20%) en el 95% de las muestras. En los tres coagulómetros evaluados, correctamente mantenidos y calibrados, la detección foto-óptica arrojó resultados equivalentes a la detección electromecánica.

The aim of this study was to determine whether two distinct methodologies based on optical or mechanical clot detection are comparable. Prothrombin time (PT), activated partial thromboplastine time (APTT) and fibrinogen results obtained with mechanical method using two different coagulometers are compared with those obtained by photo optical method within three hours of blood collection. The statistical analysis demonstrated an excellent correlation between optical or mechanical platform for TP, APTT and FBG. TP (%) showed (ACL TOP vs. STArt R=0.989; ACL TOP vs. Destiny Plus R=0.988), APTT: (ACL TOP vs. STArt R=0.938; ACL TOP vs. Destiny Plus R=0.989) y FBG (ACL TOP vs. STArt R=0.97; ACL TOP vs. Destiny Plus 0.984). The differences between optical or mechanical clot detection results are lower than the total error allowable in 95% of the studied samples. To conclude with, the three coagulometers evaluated have maintenance performed and are calibrated according to the international guidelines, and the results obtained with an optical or mechanical clot detection method are equivalent.

O objetivo deste estudo foi determinar se a detecção foto-óptica do coágulo é equivalente à detecção eletromecânica ao realizar o tempo de protrombina (TP), o tempo de tromboplastina parcial ativado (APTT) e a dosagem de fibrinogênio (FBG). Foram estudados 258 pacientes consecutivos que concorreram ao laboratório para realizar estudos de hemostasia. Foram utilizados três coagulómetros: ACL TOP (foto-óptico) e STArt e Destiny plus como detecção eletromecânica. O TP, APTT e FBG foram realizados em todos os equipamentos antes de decorridas três horas da tomada da amostra. Uma boa correlação foi conseguida entre os resultados obtidos com ambos os métodos de detecção TP (%): (ACL TOP vs. STArt R=0,989; ACL TOP vs. Destiny plus R =0,988), APTT: (ACL TOP vs.STArt R=0,938; ACL TOP vs. Destiny Plus R=0,989), e FBG (ACL TOP vs. STArt R=0,97; ACL TOP vs. Destiny Plus R=0,984). A diferença dos resultados entre plataformas é menor ao erro total permitido estabelecido pelos critérios de CLIA (ETa TP e APTT =15% e FBG 20%) em 95% das amostras. Nos três coagulómetros avaliados, corretamente mantidos e calibrados a detecção foto-óptica lança resultados equivalentes à detecção eletromecânica.

Cross-sectional study of adherence to venous thromboembolism prophylaxis guidelines in hospitalized patients. The Trombo-Brit study.

BACKGROUND: DVT is the main cause of death in hospitalized patients and thromboprophylaxis is the only way to prevent these deaths. International recommendations suggested that active monitoring of DVT/PE prophylaxis can improve the efficacy in Hospitals. METHODS: We performed a cohort study in three consecutives periods to evaluate DVT prophylaxis in 388 adults hospitalized in a General Hospital. RESULTS: 85% of the population had high risk factors for DVT. Thromboprophylaxis was in accordance with local and International guidelines (ACCP 2008) in 72.7% and 86% of the patients respectively. No significant difference could be founded between clinical and surgical patients. One every 10 patients received higher prophylaxis than suggested by guidelines and two out of ten received deficient or no prophylaxis. The worst 2 groups of patients were those with moderate/low risk of DVT and the group with a contraindication to pharmacologic prophylaxis. We observed a progressive improvement of the DVT prophylaxis in the 3 periods of evaluation. CONCLUSIONS: Although the rate of recommended thromboprophylaxis is higher than many other reports in the region we still have some areas where we need to improve. Regular audits like these are very helpful to find out what specific areas of the hospital needs some careful attention in order to have a better quality of assistance.