PharmGKB summary: heparin-induced thrombocytopenia pathway, adverse drug reaction.
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ABSTRACT:
SUBMITTER: Miller E
PROVIDER: S-EPMC8988468 | biostudies-literature | 2022 Apr
REPOSITORIES: biostudies-literature
Publications
PharmGKB summary: heparin-induced thrombocytopenia pathway, adverse drug reaction.
Miller Elise E Norwood Charles C Giles Jason B JB Huddart Rachel R Karnes Jason H JH Whirl-Carrillo Michelle M Klein Teri E TE
Pharmacogenetics and genomics 20220401 3
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Project description:BackgroundHeparin-induced thrombocytopenia (HIT) is a life-threatening thrombotic complication after heparin exposure. However, the role of ADAMTS-13 and von Willebrand factor (VWF) in the disease process and outcomes of HIT is not known.ObjectiveTo determine the potential role of ADAMTS-13 and VWF in hospitalized patients suspected with HIT.MethodsAssociations of the HIT tests, ADAMTS-13 activity, and VWF antigen or activity with other clinical parameters and outcomes in the patients suspected with HIT were determined.ResultsOf 261 patients, 87 (33.3%) were positive and 174 (66.7%) were negative for a HIT antibody determined by an enzyme immunoassay (EIA). Of these 87 EIA+ patients, 31 (35.6%) were also positive but 56 (64.4%) were negative for serotonin-releasing assay (SRA). There was no statistically significant difference among all three groups (i.e., EIA-, EIA+/SRA+, and EIA+/SRA-) as to their demographic features, reasons for admission to the hospital, type of procedures performed, and in-hospital mortality. Compared to those in the healthy controls, plasma ADAMTS-13 activity in patients suspected with HIT was significantly lower but plasma VWF antigen (VWFAg) and activity (VWFAc) in these patients were significantly higher. While there was no statistically significant difference among all three groups regarding plasma levels of ADAMTS-13 activity, VWFAg, and VWFAc, plasma levels of ADAMTS-13 activity <50% or the low ratios of ADAMTS-13 activity to VWFAg (or VWFAc) are highly predictive for a 90-day mortality rate, particularly in the EIA+SRA+ group.ConclusionsThese results demonstrate that relative deficiency of plasma ADAMTS-13 activity in hospitalized patients suspected with HIT is common, which may contribute at least in part to the adverse outcomes in this patient population, particularly in those with true HIT.
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Project description:ImportanceHeparin-induced thrombocytopenia (HIT) is a life-threatening condition that requires urgent diagnostic clarification. However, knowledge of the diagnostic utility of the recommended diagnostic tests is limited in clinical practice.ObjectiveTo evaluate the current diagnostic practice for managing the suspicion of HIT.Design, setting, and participantsThis prospective diagnostic study was conducted from January 2018 to May 2021 among consecutive patients with suspected HIT from 11 study centers in Switzerland, Germany, and the United States. Detailed clinical data and laboratory information were recorded. Platelet factor 4/heparin antibodies were quantified using an automated chemiluminescent immunoassay (CLIA). A washed-platelet heparin-induced platelet activation (HIPA) test was used as a reference standard to define HIT.ExposuresSuspicion of HIT.Main outcomes and measuresThe primary outcome was the diagnostic accuracy of the 4Ts score, the CLIA, and the recommended algorithm serially combining both tests.ResultsOf 1448 patients included between 2018 and 2021, 1318 were available for the current analysis (median [IQR] age, 67 [57-75] years; 849 [64.6%] male). HIPA was positive in 111 patients (prevalence, 8.4%). The most frequent setting was intensive care unit (487 [37.0%]) or cardiovascular surgery (434 [33.0%]). The 4Ts score was low risk in 625 patients (46.8%). By 2 × 2 table, the numbers of patients with false-negative results were 10 (9.0%; 4Ts score), 5 (4.5%; CLIA), and 15 (13.5%; recommended diagnostic algorithm). The numbers of patients with false-positive results were 592 (49.0%; 4Ts score), 73 (6.0%; CLIA), and 50 (4.1%; recommended diagnostic algorithm), respectively.Conclusions and relevanceIn this diagnostic study of patients suspected of having HIT, when the recommended diagnostic algorithm was used in clinical practice, antibody testing was required in half the patients. A substantial number of patients were, however, still misclassified, which could lead to delayed diagnosis or overtreatment. Development of improved diagnostic algorithms for HIT diagnosis should be pursued.
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