title: [Renal function and plasma dabigatran level measured at trough by diluted thrombin time assay].
abstract: Dabigatran etexilate (direct thrombin inhibitor) is effective in preventing embolic stroke in patients with atrial fibrillation. It does not require laboratory control, but given the high renal elimination, its measurement in plasma is important in renal failure. The objectives of the study were to verify the analytical quality of the diluted thrombin time assay for measurement of dabigatran plasma concentration (cc), correlate cc with classic coagulation assays, prothrombin time (PT) and activated partial thromboplastin time (APTT), and evaluate them according to the creatinine clearance (CLCr). Forty plasma samples of patients (34 consecutive and 6 suspected of drug accumulation) receiving dabigatran at 150 (n = 19) or 110 (n = 21) mg/12 hours were collected. Blood samples were drawn at 10-14 hours of the last intake. Dabigatran concentration was determined by diluted thrombin time (HemosIl DTI, Instrumentation Laboratory (IL). PT and APTT (IL) were performed on two fotooptical coagulometers, ACL TOP 300 and 500 (IL). DTI presented intra-assay coefficient of variation < 5.4% and inter-assay < 6%, linearity range 0-493 ng/ml. Patients' cc: median 83 (4-945) ng/ml. Individuals with CLCr in the lowest tertile (22.6-46.1 ml/min) showed significantly higher median cc: 308 (49-945), compared to the average 72 (12-190) and highest tertile, 60 (4-118) ng/ml. Correlation between cc and APTT or PT were moderate, r2 = 0.59 and -0.66, p < 0.0001, respectively. DTI test allowed us to quantify plasma dabigatran levels, both in patients with normal or altered renal function, representing a useful tool in clinical situations such as renal failure, pre surgery or emergencies.
authors.affiliation: Grupo Bioquímico, Laboratorio Central, Hospital Italiano de Buenos Aires, Argentina. E-mail: memartinuzzo@gmail.com.|Instituto Universitario Hospital Italiano, Buenos Aires, Argentina. E-mail: memartinuzzo@gmail.com.
authors.forename: Marta E
authors.initials: ME
authors.lastname: Martinuzzo
authors.affiliation: Servicio de Hematología, Hospital Británico de Buenos Aires, Argentina.
authors.forename: Cristina
authors.initials: C
authors.lastname: Duboscq
authors.affiliation: Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.|Servicio de Hematología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Estela S
authors.initials: ES
authors.lastname: Viñuales
authors.affiliation: Servicio de Hematología, Hospital Italiano de Buenos Aires, Argentina.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Girardi
authors.affiliation: Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.|Servicio de Hematología, Hospital Italiano de Buenos Aires, Argentina.
authors.forename: Diana
authors.initials: D
authors.lastname: Penchasky
authors.affiliation: Servicio de Hematología, Hospital Británico de Buenos Aires, Argentina.
authors.forename: José
authors.initials: J
authors.lastname: Ceresetto
authors.affiliation: Servicio de Hematología, Hospital Británico de Buenos Aires, Argentina.
authors.forename: Germán
authors.initials: G
authors.lastname: Stemmelin
authors.affiliation: Servicio de Hematología, Hospital Italiano de Buenos Aires, Argentina.
authors.forename: Victoria
authors.initials: V
authors.lastname: Otero
authors.affiliation: Grupo Bioquímico, Laboratorio Central, Hospital Italiano de Buenos Aires, Argentina.|Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.
authors.forename: Luis H
authors.initials: LH
authors.lastname: Barrera
authors.affiliation: Grupo Bioquímico, Laboratorio Central, Hospital Italiano de Buenos Aires, Argentina.
authors.forename: Marina S
authors.initials: MS
authors.lastname: López
authors.affiliation: Grupo Bioquímico, Laboratorio Central, Hospital Italiano de Buenos Aires, Argentina.|Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Otaso
authors.affiliation: Grupo Bioquímico, Laboratorio Central, Hospital Italiano de Buenos Aires, Argentina.|Instituto Universitario Hospital Italiano, Buenos Aires, Argentina.
authors.forename: José
authors.initials: J
authors.lastname: Hoyhamburu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000991:Antithrombins / Q000097:blood*; D003404:Creatinine / Q000097:blood*; D000069604:Dabigatran / Q000097:blood*; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time; D051437:Renal Insufficiency / Q000097:blood; D013918:Thrombin Time; D055815:Young Adult
chemical_list: D000991:Antithrombins; D003404:Creatinine; D000069604:Dabigatran
keywords: dabigatran; plasma dabigatran measurement; renal function