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Towards precise and rapid diagnosis of heparin-induced thrombocytopenia: a prospective, multicentre cohort study (“TORADI-HIT”)

English title Towards precise and rapid diagnosis of heparin-induced thrombocytopenia: a prospective, multicentre cohort study (“TORADI-HIT”)
Applicant Nagler Michael
Number 179334
Funding scheme Project funding
Research institution Institut für Klinische Chemie Inselspital Bern
Institution of higher education University of Berne - BE
Main discipline Internal Medicine
Start/End 01.06.2018 - 31.05.2021
Approved amount 555'750.00
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All Disciplines (2)

Discipline
Internal Medicine
Clinical Cardiovascular Research

Keywords (5)

Arterial thromboembolism; Thrombocytopenia/ drug induced; Heparin/ adverse events; Venous thromboembolism; Diagnostic Techniques and Procedures/standards

Lay Summary (German)

Lead
Die Heparin-induzierte Thrombozytopenie (HIT) ist eine lebensbedrohliche Komplikation der Therapie mit Heparin, welche eine relevante Anzahl von Patienten betrifft. Wenn die Entstehung einer HIT verpasst wird, drohen sehr ernsthafte Komplikationen. Die verfügbaren diagnostischen Instrumente sind jedoch mit Nachteilen verbunden und viele Autoren erachten die verfügbaren diagnostischen Tests daher als inadäquat.
Lay summary

Inhalt und Ziele des Forschungsprojektes

Das Ziel der vorliegenden Untersuchung ist es, ein Vorhersagemodell (“clinical prediction rule”) für die Diagnose der HIT zu entwickeln und zu validieren.

In einer prospektiven, randomisierten Kohortenstudie («TORADI-HIT») werden wir 750 Patienten mit vermuteter HIT einschliessen. Als potentielle Prädiktoren werden wir eine Reihe von klinischen Charakteristika und Laborparameter erfassen. Übriggebliebene Serumproben werden wir nutzen, um zusätzliche Immunassays und einen Goldstandard-Test für die HIT durchzuführen (HIPA). Diese Daten werden benutzt, um ein Vorhersagemodell zu entwickeln und zu validieren. Der diagnostische Nutzen dieses Vorhersagemodells wird anschliessend verglichen mit existierenden Instrumenten.

Kontext:

Die vorliegende Studie beabsichtigt, ein Instrument für die rasche und akkurate Vorhersage einer HIT am Krankenbett zu entwickeln. Sollte dieses Ziel erreicht werden, kann nicht nur die Versorgung dieser kritisch kranken Menschen verbessert sondern auch Gesundheitskosten relevant reduziert werden.

Direct link to Lay Summary Last update: 18.05.2018

Responsible applicant and co-applicants

Employees

Publications

Publication
Impaired kidney function at ED admission: a comparison of bleeding complications of patients with different oral anticoagulants
Müller Martin, Traschitzger Michaela, Nagler Michael, Arampatzis Spyridon, Exadaktylos Aristomenis K., Sauter Thomas C. (2021), Impaired kidney function at ED admission: a comparison of bleeding complications of patients with different oral anticoagulants, in BMC Emergency Medicine, 21(1), 105-105.
Falls in ED patients: do elderly patients on direct oral anticoagulants bleed less than those on vitamin K antagonists?
Müller Martin, Chanias Ioannis, Nagler Michael, Exadaktylos Aristomenis K., Sauter Thomas C. (2021), Falls in ED patients: do elderly patients on direct oral anticoagulants bleed less than those on vitamin K antagonists?, in Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, 29(1), 56-56.
Long-Term Survival After Venous Thromboembolism: A Prospective Cohort Study
Nilius Henning, Mertins Tamara, Boss Robin, Knuchel Matthias, Blozik Eva, Kremer Hovinga Johanna Anna, Eichinger Sabine, Nagler Michael (2021), Long-Term Survival After Venous Thromboembolism: A Prospective Cohort Study, in Frontiers in Cardiovascular Medicine, 8, 749342.
Automated Thrombin Generation Assay for Rivaroxaban, Apixaban, and Edoxaban Measurements
Meihandoest Tamana, Studt Jan-Dirk, Mendez Adriana, Alberio Lorenzo, Fontana Pierre, Wuillemin Walter A., Schmidt Adrian, Graf Lukas, Gerber Bernhard, Maeder Gabriela Monika, Bovet Cédric, Sauter Thomas C., Nagler Michael (2021), Automated Thrombin Generation Assay for Rivaroxaban, Apixaban, and Edoxaban Measurements, in Frontiers in Cardiovascular Medicine, 8, 717939.
Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings
Jegerlehner Sabrina, Suter-Riniker Franziska, Jent Philipp, Bittel Pascal, Nagler Michael (2021), Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings, in International Journal of Infectious Diseases, 109, 118-122.
Comparative effectiveness and safety of anticoagulants for the treatment of heparin‐induced thrombocytopenia
Nilius Henning, Kaufmann Jonas, Cuker Adam, Nagler Michael (2021), Comparative effectiveness and safety of anticoagulants for the treatment of heparin‐induced thrombocytopenia, in American Journal of Hematology, 96(7), 805-815.
Accuracy of the functional, flow cytometer-based Emo-Test HIT Confirm® for the diagnosis of heparin-induced thrombocytopenia
Brodard Justine, Benites Vincent, Stalder Zeerleder Denise, Nagler Michael (2021), Accuracy of the functional, flow cytometer-based Emo-Test HIT Confirm® for the diagnosis of heparin-induced thrombocytopenia, in Thrombosis Research, 203, 22-26.
A universal anti‐Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation
Willekens Guido, Studt Jan‐Dirk, Mendez Adriana, Alberio Lorenzo, Fontana Pierre, Wuillemin Walter A., Schmidt Adrian, Graf Lukas, Gerber Bernhard, Bovet Cedric, Sauter Thomas C., Nagler Michael (2021), A universal anti‐Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation, in British Journal of Haematology, 193(6), 1203-1212.
How would we treat our own heparin-induced thrombocytopenia during cardiac surgery?
Koster Andreas, Erdoes Gabor, Nagler Michael, Birschmann Ingvild, Alberio Lorenzo (2021), How would we treat our own heparin-induced thrombocytopenia during cardiac surgery?, in Journal of Cardiothoracic and Vascular Anesthesia, 35(6), 1585-1593.
Predicting Recurrent Venous Thromboembolism in Patients With Deep-Vein Thrombosis: Development and Internal Validation of a Potential New Prediction Model (Continu-8)
Nagler Michael, Van Kuijk Sander M. J., Ten Cate Hugo, Prins Martin H., Ten Cate-Hoek Arina J. (2021), Predicting Recurrent Venous Thromboembolism in Patients With Deep-Vein Thrombosis: Development and Internal Validation of a Potential New Prediction Model (Continu-8), in Frontiers in Cardiovascular Medicine, 8, 655226.
Immunoadsorption for the Treatment of Acquired Hemophilia: New Observational Data, Systematic Review, and Meta-Analysis
Esteves Pereira Michael, Bocksrucker Christoph, Kremer Hovinga Johanna Anna, Mueller Martin, Daskalakis Michael, Mansouri Taleghani Behrouz, Nagler Michael (2021), Immunoadsorption for the Treatment of Acquired Hemophilia: New Observational Data, Systematic Review, and Meta-Analysis, in Transfusion Medicine Reviews, 35(2), 125-134.
Response by Gargiulo et al to Letter Regarding Article, “Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment–Elevation Myocardial Infarction: Primary Results of the FABOLUS FASTER Trial”
Gargiulo Giuseppe, Nagler Michael, Valgimigli Marco (2021), Response by Gargiulo et al to Letter Regarding Article, “Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment–Elevation Myocardial Infarction: Primary Results of the FABOLUS FASTER Trial”, in Circulation, 143(13), e797.
Effects of Hypericum perforatum (St John's wort) on the pharmacokinetics and pharmacodynamics of rivaroxaban in humans
Scholz Irene, Liakoni Evangelia, Hammann Felix, Grafinger Katharina Elisabeth, Duthaler Urs, Nagler Michael, Krähenbühl Stephan, Haschke Manuel (2021), Effects of Hypericum perforatum (St John's wort) on the pharmacokinetics and pharmacodynamics of rivaroxaban in humans, in British Journal of Clinical Pharmacology, 87(3), 1466-1474.
Andexanet Alfa–Induced Heparin Resistance: When Anticoagulation Really Remains Reversed
Erdoes Gabor, Birschmann Ingvild, Nagler Michael, Koster Andreas (2021), Andexanet Alfa–Induced Heparin Resistance: When Anticoagulation Really Remains Reversed, in Journal of Cardiothoracic and Vascular Anesthesia, 35(3), 908-909.
Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over PrasugreL: a MUlticenter Randomized Open-label Trial in PatientS with ST-elevation Myocardial InFarction Referred for PrimAry PercutaneouS InTERvention (FABOLUS FASTER) Trial: Design and RationaleThe FABOLUS FASTER Trial
Gargiulo Giuseppe, Esposito Giovanni, Cirillo Plinio, Nagler Michael, Minuz Pietro, Campo Gianluca, Gragnano Felice, Manavifar Negar, Piccolo Raffaele, Avvedimento Marisa, Tebaldi Matteo, Wahl Andreas, Hunziker Lukas, Billinger Michael, Heg Dik, Windecker Stephan, Valgimigli Marco (2021), Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over PrasugreL: a MUlticenter Randomized Open-label Trial in PatientS with ST-elevation Myocardial InFarction Referred for PrimAry PercutaneouS InTERvention (FABOLUS FASTER) Trial: Design and RationaleThe FABOLUS FASTER Trial, in Journal of Cardiovascular Translational Research, 14(1), 110-119.
Trends in Micronutrient Laboratory Testing in Switzerland: A 7-Year Retrospective Analysis of Healthcare Claims Data
Huber Carola A, Nagler Michael, Rosemann Thomas, Blozik Eva, Näpflin Markus, Markun Stefan (2020), Trends in Micronutrient Laboratory Testing in Switzerland: A 7-Year Retrospective Analysis of Healthcare Claims Data, in International Journal of General Medicine, Volume 13, 1341-1348.
Utility of the Platelet Function Analyzer in Patients with Suspected Platelet Function Disorders: Diagnostic Accuracy Study
Kaufmann Jonas, Adler Marcel, Alberio Lorenzo, Nagler Michael (2020), Utility of the Platelet Function Analyzer in Patients with Suspected Platelet Function Disorders: Diagnostic Accuracy Study, in TH Open, 04(04), e427-e436.
Translating Laboratory Tests into Clinical Practice: A Conceptual Framework
Nagler Michael (2020), Translating Laboratory Tests into Clinical Practice: A Conceptual Framework, in Hämostaseologie, 40(04), 420-429.
System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings
Kitchen Steve, de Maat Moniek, Nagler Michael, Jones Robert, Lowe Anna, Burden John, Groneberg Kai, Rozsnyai Gergely (2020), System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings, in Blood Coagulation & Fibrinolysis, 31(7), 459-468.
Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment–Elevation Myocardial InfarctionPrimary Results of the FABOLUS-FASTER Trial
Leonardi Sergio, Heg Dik, Windecker Stephan, Valgimigli Marco, Gargiulo Giuseppe, Esposito Giovanni, Avvedimento Marisa, Nagler Michael, Minuz Pietro, Campo Gianluca, Gragnano Felice, Manavifar Negar, Piccolo Raffaele, Tebaldi Matteo, Cirillo Plinio, Hunziker Lukas, Vranckx Pascal (2020), Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment–Elevation Myocardial InfarctionPrimary Results of the FABOLUS-FASTER Trial, in Circulation, 142(5), 441-454.
CME-Labor 62: Wie beurteile ich den Nutzen eines Labortests? Beispiel der D-Dimere
Nagler Michael (2020), CME-Labor 62: Wie beurteile ich den Nutzen eines Labortests? Beispiel der D-Dimere, in Praxis, 109(7), 539-545.
Recommendations on the use of anticoagulants for the treatment of patients with heparin-induced thrombocytopenia in Switzerland
Alberio Lorenzo, Angelillo-Scherrer Anne, Asmis Lars, Casini Alessandro, Fontana Pierre, Graf Lukas, Hegemann Inga, Kremer Hovinga Johanna A., Korte Wolfgang, Lecompte Thomas, Martinez Martina, Nagler Michael, Studt Jan-Dirk, Tsakiris Dimitrios A., Wuillemin Walter (2020), Recommendations on the use of anticoagulants for the treatment of patients with heparin-induced thrombocytopenia in Switzerland, in Swiss Medical Weekly, 150, w20210.
Thromboprophylaxis and laboratory monitoring for in-hospital patients with Covid-19 - a Swiss consensus statement by the Working Party Hemostasis
Casini Alessandro, Alberio Lorenzo, Angelillo-Scherrer Anne, Fontana Pierre, Gerber Bernhard, Graf Lukas, Hegemann Inga, Korte Wolfgang, Kremer Hovinga Johanna, Lecompte Thomas, Martinez Maria, Nagler Michael, Studt Jan-Dirk, Tsakiris Dimitrios, Wuillemin Walter, Asmis Lars (2020), Thromboprophylaxis and laboratory monitoring for in-hospital patients with Covid-19 - a Swiss consensus statement by the Working Party Hemostasis, in Swiss Medical Weekly, w20247.
Rivaroxaban in patients with mechanical heart valves: A pilot study
Roost Eva, Weber Alberto, Alberio Lorenzo, Englberger Lars, Reineke David, Keller Dorothée, Nagler Michael, Carrel Thierry (2020), Rivaroxaban in patients with mechanical heart valves: A pilot study, in Thrombosis Research, 186, 1-6.
Accuracy of heparin-induced platelet aggregation test for the diagnosis of heparin-induced thrombocytopenia
Brodard Justine, Alberio Lorenzo, Angelillo-Scherrer Anne, Nagler Michael (2020), Accuracy of heparin-induced platelet aggregation test for the diagnosis of heparin-induced thrombocytopenia, in Thrombosis Research, 185, 27-30.
Application of prothrombin complex concentrate for reversal of direct oral anticoagulants in clinical practice: indications, patient characteristics and clinical outcomes compared to reversal of vitamin K antagonists
Müller Martin, Eastline Jonathan, Nagler Michael, Exadaktylos Aristomenis K., Sauter Thomas C. (2019), Application of prothrombin complex concentrate for reversal of direct oral anticoagulants in clinical practice: indications, patient characteristics and clinical outcomes compared to reversal of vitamin K antagonists, in Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, 27(1), 48-48.
Rapid Centrifugation in the Routine Hemostasis Laboratory
Wolfensberger Nathan, Georgiou Georgios, Giabbani Evelyne, Reusser Marianne, Njue Linet M., Fiedler Martin, Leichtle Alexander B., Nagler Michael (2019), Rapid Centrifugation in the Routine Hemostasis Laboratory, in Thrombosis and Haemostasis, 119(12), 2025-2033.
Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability
Calzavarini Sara, Brodard Justine, Quarroz Claudia, Maire Livia, Nützi Raphael, Jankovic Jovana, Rotondo Laura C., Giabbani Evelyne, Fiedler Georg Martin, Nagler Michael, Angelillo-Scherrer Anne (2019), Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability, in Research and Practice in Thrombosis and Haemostasis, 3(4), 758-768.
Shorter Hospital Stay and Fewer Hospitalizations in Patients With Visible Hematuria on Direct Oral Anticoagulants Compared to on Vitamin K Antagonists
Müller Martin, Bosshard Flavio, Nagler Michael, Roth Beat, Exadaktylos Aristomenis K., Sauter Thomas C. (2019), Shorter Hospital Stay and Fewer Hospitalizations in Patients With Visible Hematuria on Direct Oral Anticoagulants Compared to on Vitamin K Antagonists, in Urology, 132, 101-108.
Diagnostic utility of the ISTH bleeding assessment tool in patients with suspected platelet function disorders
Adler Marcel, Kaufmann Jonas, Alberio Lorenzo, Nagler Michael (2019), Diagnostic utility of the ISTH bleeding assessment tool in patients with suspected platelet function disorders, in Journal of Thrombosis and Haemostasis, 17(7), 1104-1112.
Enhanced Thrombolysis by Ultrasound-Assisted Catheter-Directed Thrombolysis and Microbubbles in an In Vitro Model of Iliofemoral Deep Vein Thrombosis
Engelberger Rolf P., Schroeder Verena, Nagler Michael, Prince Raja, Périard Daniel, Hayoz Daniel, Kucher Nils (2019), Enhanced Thrombolysis by Ultrasound-Assisted Catheter-Directed Thrombolysis and Microbubbles in an In Vitro Model of Iliofemoral Deep Vein Thrombosis, in Thrombosis and Haemostasis, 119(07), 1094-1101.
Thromboelastometry as a diagnostic tool in mild bleeding disorders: A prospective cohort study
Wieland Greguare-Sander Anna, Wuillemin Walter A., Nagler Michael (2019), Thromboelastometry as a diagnostic tool in mild bleeding disorders: A prospective cohort study, in European Journal of Anaesthesiology, 36(6), 457-465.
Characteristics, treatment and outcome of bleeding after tooth extraction in patients on DOAC and phenprocoumon compared to non-anticoagulated patients—a retrospective study of emergency department consultations
Müller Martin, Schlittler Fabian, Schaller Benoit, Nagler Michael, Exadaktylos Aristomenis K., Sauter Thomas C. (2019), Characteristics, treatment and outcome of bleeding after tooth extraction in patients on DOAC and phenprocoumon compared to non-anticoagulated patients—a retrospective study of emergency department consultations, in Clinical Oral Investigations, 23(5), 2273-2278.
A high Gas6 level in plasma predicts venous thromboembolism recurrence, major bleeding and mortality in the elderly: a prospective multicenter cohort study
Schnegg‐Kaufmann Annatina, Calzavarini Sara, Limacher Andreas, Mean Marie, Righini Marc, Staub Daniel, Beer Juerg‐Hans, Frauchiger Beat, Osterwalder Joseph, Kucher Nils, Matter Christian M., Husmann Marc, Banyai Martin, Aschwanden Markus, Mazzolai Lucia, Hugli Oliver, Nagler Michael, Daskalakis Michael, Rodondi Nicolas, Aujesky Drahomir, Angelillo‐Scherrer Anne (2019), A high Gas6 level in plasma predicts venous thromboembolism recurrence, major bleeding and mortality in the elderly: a prospective multicenter cohort study, in Journal of Thrombosis and Haemostasis, 17(2), 306-318.
Next generation viscoelasticity assays in cardiothoracic surgery: Feasibility of the TEG6s system
Erdoes Gabor, Schloer Hannes, Eberle Balthasar, Nagler Michael (2018), Next generation viscoelasticity assays in cardiothoracic surgery: Feasibility of the TEG6s system, in PLOS ONE, 13(12), e0209360-e0209360.
Association of anemia and hemoglobin decrease during acute stroke treatment with infarct growth and clinical outcome
Bellwald Sebastian, Balasubramaniam Rupashani, Nagler Michael, Burri Meret S., Fischer Samuel D. A., Hakim Arsany, Dobrocky Tomas, Yu Yannan, Scalzo Fabien, Heldner Mirjam R., Wiest Roland, Mono Marie-Luise, Sarikya Hakan, El-Koussy Marwan, Mordasini Pasquale, Fischer Urs, Schroth Gerhard, Gralla Jan, Mattle Heinrich P., Arnold Marcel, Liebeskind David, Jung Simon (2018), Association of anemia and hemoglobin decrease during acute stroke treatment with infarct growth and clinical outcome, in PLOS ONE, 13(9), e0203535-e0203535.
Short-term recovery pattern of plasma fibrinogen after cardiac surgery: A prospective observational study
Erdoes Gabor, Dietrich Wulf, Stucki Monika Pia, Merz Tobias Michael, Angelillo-Scherrer Anne, Nagler Michael, Carrel Thierry, Eberle Balthasar (2018), Short-term recovery pattern of plasma fibrinogen after cardiac surgery: A prospective observational study, in PLOS ONE, 13(8), e0201647-e0201647.
Short-term recovery pattern of plasma fibrinogen after cardiac surgery: A prospective observational study
Erdoes Gabor, Dietrich Wulf, Stucki Monika Pia, Merz Tobias Michael, Angelillo-Scherrer Anne, Nagler Michael, Carrel Thierry, Eberle Balthasar (2018), Short-term recovery pattern of plasma fibrinogen after cardiac surgery: A prospective observational study, in PLOS ONE, 13(8), e0201647-e0201647.
Accuracy, reproducibility and costs of different laboratory assays for the monitoring of unfractionated heparin in clinical practice: a prospective evaluation study and survey among Swiss institutions
Bürki Susanne, Brand Béatrice, Escher Robert, Wuillemin Walter A, Nagler Michael (2018), Accuracy, reproducibility and costs of different laboratory assays for the monitoring of unfractionated heparin in clinical practice: a prospective evaluation study and survey among Swiss institutions, in BMJ Open, 8(6), e022943-e022943.
Risk factors for recurrence in deep vein thrombosis patients following a tailored anticoagulant treatment incorporating residual vein obstruction
Nagler Michael, ten Cate Hugo, Prins Martin H., ten Cate-Hoek Arina J. (2018), Risk factors for recurrence in deep vein thrombosis patients following a tailored anticoagulant treatment incorporating residual vein obstruction, in Research and Practice in Thrombosis and Haemostasis, 2(2), 299-309.
How I manage patients with anticoagulation-associated bleeding or urgent surgery
SauterTC, EberleB, WuilleminWA, ThieleT, Angelillo-ScherrerA, ExadaktylosAK, ErdoesG, CukerA, NaglerM (2018), How I manage patients with anticoagulation-associated bleeding or urgent surgery, in Swiss Medical Weekly, 148(1112), w14598.
Long-term survival after venous thromboembolism: A prospective cohort study
Nilius Henning, MertinsTamana, BossRobin, KnuchelMatthias, BlozikEva, Kremer HovingaJohanna Anna, EichingerSabine, NaglerMichael, Long-term survival after venous thromboembolism: A prospective cohort study, in Frontiers in cardiovascular medicine.

Collaboration

Group / person Country
Types of collaboration
Transfusionsmedizin Universität Tübingen (Prof. T. Bakchoul) Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
Transfusionsmedizin Universität Greifswald (Prof. Greinacher) Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Exchange of personnel

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Swiss Oncology & Hematology Congress (SOHC) Talk given at a conference Feasibility of a new, rapid functional assay for the diagnosis of heparin-induced thrombocytopenia: a standardized flow cytometry assay 26.06.2019 Zürich , Switzerland Benites Vincent; Stalder Anja; Nagler Michael;
Onko-Lunch Triemlispital Individual talk Diagnosis and treatment of heparin-induced thrombocytopenia 24.06.2019 Zürich, Switzerland Nagler Michael;
Colloque du Service d'angiologie et d'hémostase, HUG Individual talk HIT: diagnosis and treatment in 2019 04.04.2019 Geneve, Switzerland Nagler Michael;
Fortbildung Innere Medizin/ Zentrum für Labormedizin, Kantonsspital St. Gallen Individual talk Heparin-induzierte Thrombozytopenie 2019 21.01.2019 St. Gallen, Switzerland Nagler Michael;
64th Annual Scientific and Standardization Committee (SSC) of the ISTH Talk given at a conference Towards precise and rapid diagnosis of heparin-induced thrombocytopenia 18.07.2018 Dublin, Ireland Nagler Michael;
Swiss Oncology & Hematology Congress Talk given at a conference Challenges in diagnosing heparin-induced thrombocytopenia 27.06.2018 Zürich, Switzerland Nagler Michael;
Swiss Oncology & Hematology Congress Talk given at a conference Accuracy of Heparin-Induced Platelet Aggregometry for the diagnosis of heparin-induced thrombocytopenia 27.06.2018 Zürich, Switzerland Nagler Michael;


Communication with the public

Communication Title Media Place Year
Media relations: print media, online media Corona-Schnelltest besonders mangelhaft bei symptomfrei Infizierten SWISSINFO International 2021
Media relations: radio, television 10 vor 10 SRF 1 German-speaking Switzerland 2021
Media relations: print media, online media Antigen-Schnelltest fallen bei Studie durch: Nur zwei Drittel aller positiven Fälle werden richtig e Tagblatt German-speaking Switzerland 2021
Media relations: print media, online media Berner Forscher bemängeln Coronatests Blick German-speaking Switzerland 2021
Media relations: print media, online media Berner Inselspital stellt den Roche-Schnelltests ein schlechtes Zeugnis aus Aargauer Zeitung German-speaking Switzerland 2021
Media relations: print media, online media Forscher warnen vor vier Wochen Impfabstand bei AstraZeneca ZEIT online International 2021
Media relations: print media, online media Online Nau German-speaking Switzerland 2021
Media relations: radio, television Tagesschau SRF 1 German-speaking Switzerland 2021

Abstract

Background: Heparin-induced thrombocytopenia (HIT) is a life-threatening complication of heparin treatment, which affects a significant number of patients. If missed and untreated, HIT often leads to very serious consequences. Available diagnostic tests, however, are associated with important drawbacks. In clinical practice, we not only miss patients suffering from HIT but also unnecessarily treat many patients without HIT with costly and risky alternative anticoagulants. Hence, many authors consider current diagnostic approaches to be inadequate in clinical practice. Clinical prediction rules, incorporating a broad spectrum of clinical and laboratory information might significantly improve diagnostic procedures and can guide clinical decision-making.Own research related to proposed project: My previous work has focused on clinical research investigating diagnostic tests and predictive measures, particularly with regard to HIT. I conducted a number of projects as principle investigator or responsible corresponding author. In a systematic review and meta-analysis, I established likelihood ratios for all immunoassays available at different thresholds 1. I conducted studies to investigate the diagnostic value of immunoassays 2 and clinical assessment tools 3,4 in patients with suspected HIT. In addition, I derived and validated prediction models for anticoagulation quality 5, and recurrent venous thromboembolism 6,7.Aims and objectives: The main aim of the proposed work is to develop and internally validate a clinical prediction rule for the diagnosis of HIT.Methods: In a prospective, multicentre cohort study (“TORADI-HIT”) we will include 750 patients with suspected HIT. As potential predictors for the diagnostic model we will collect a number of clinical characteristics and laboratory data that are routinely obtained in clinical practice. Using residual serum sample, additionally immunassays and a reference standard test (HIPA) will be conducted in the central laboratory. Using the outputs of this work, a clinical prediction model will be developed and internally validated. The diagnostic accuracy of the new tool will be compared to available clinical assessment tools and immunassays.Infrastructure, project linkage and partners: As head of the haemostasis laboratory at Inselspital University Hospital, I am able to use the infrastructure of this large, specialised haemostasis facility with extensive experience both in HIT diagnosis and in performing large-scale clinical studies. An international team of well-recognised physicians, epidemiologists and laboratory specialists (including many of the most significant experts in HIT) supports the proposed project through provision of their expertise as well as access to patients. The national study group, the Working Party Haemostasis (WPH) of the Swiss Society of Haematology joined by the heads of all haemostasis laboratories in Switzerland, will ensure fast recruitment and inclusion of patients.Significance of the proposed project: Our evaluation study will seek to establish that the diagnosis of HIT can be accurately predicted in individual patients at the bedside. Should this goal be realised, our research may not only help to improve patient care and outcomes by ensuring appropriate treatments are administered, but also in doing so limit health care costs.
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