title: Evaluation of ProC Global assay in women with a history of venous thromboembolism on hormonal therapy.
abstract: The risk of thrombosis in women increases significantly during treatment with hormonal therapy (HT). The aim of this study was to evaluate ProC Global assay in women with a history of venous thromboembolism (VTE) while using HT. Protein C activation time normalized ratio (PCAT-NR) levels were significantly lower in 32 women with a history of VTE while using HT (0.72 +/- 0.1) compared with 56 healthy controls without HT, matched by age at blood sampling (0.99 +/- 0.2) and 40 healthy controls with HT, matched by age and HT at VTE event (0.94 +/- 0.2) (P < 0.001 for both). PCAT-NR lower than the cut-off level of 0.8 was found in 23/32 (72%) patients compared with 5/56 (9%) age-matched controls (OR = 26, 95%CI: 7-106, P < 0.001) and 9/40 (22.5%) of HT-matched controls (OR = 9, 95%CI: 2.7-30, P < 0.001). Any thrombophilic risk factor was found in 20/32 (62.5%) of patients compared with 12/56 (21.4%) of agematched controls (OR = 6, 95%CI: 2.1-10, P < 0.001) and 12/40 (30%) of HT-matched controls (OR = 4, 95%CI: 1.3-11.8, P = 0.006). Out of the variables that are risk factors of VTE as age, HT or thrombophilic risk factor, ProC Global assay was found in the multivariate analysis - logistic regression, as the parameter that was the most associated with patient group [Exp(B) = 15.8, 95% CI: 4.2-59.0, P < 0.001]. In conclusion, abnormal PCAT-NR is associated with VTE in women using HT. ProC Global assay may potentially serve as a diagnostic tool for evaluating the risk of VTE in women prior to administration of HT.
authors.affiliation: Thrombosis and Hemostasis Unit, Rambam Health Care campus, Haifa 31096, Israel. g_sarig@rambam.health.gov.il
authors.forename: Galit
authors.initials: G
authors.lastname: Sarig
authors.forename: Irit
authors.initials: I
authors.lastname: Aberbach
authors.forename: Liliana
authors.initials: L
authors.lastname: Schliamser
authors.forename: Zeev
authors.initials: Z
authors.lastname: Blumenfeld
authors.forename: Benjamin
authors.initials: B
authors.lastname: Brenner
mesh_terms: D000328:Adult; D001780:Blood Coagulation Tests; D016022:Case-Control Studies; D005260:Female; D020249:Hormone Replacement Therapy / Q000009:adverse effects*; D006801:Humans; D008875:Middle Aged; D011486:Protein C / Q000032:analysis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012307:Risk Factors; D013923:Thromboembolism / Q000175:diagnosis; D019851:Thrombophilia; D020246:Venous Thrombosis / Q000175:diagnosis*
chemical_list: D011486:Protein C; D011933:Reagent Kits, Diagnostic