Article, 2024
Accuracy of Diagnosing Heparin-Induced Thrombocytopenia
JAMA Network Open,
ISSN
2574-3805,
Volume 7,
3,
Page e243786,
10.1001/jamanetworkopen.2024.3786
Contributors
Larsen, Emil List
0000-0002-0676-0858
[1]
Nilius, Henning
0000-0002-1323-3116
[2]
[3]
Studt, Jan-Dirk
[4]
Tsakiris, Dimitrios Athanasios
[5]
Greinacher, Andreas
0000-0001-8343-7336
[6]
Mendez, Adriana
[7]
Schmidt, Adrian
[8]
Wuillemin, Walter A
0000-0003-4130-7626
[3]
Gerber, Bernhard
0000-0001-5418-0949
[9]
Vishnu, Prakash
0000-0002-9254-8094
[10]
[11]
Graf, L Genton
0000-0002-5556-4351
[12]
Hovinga, Johanna A. Kremer
[2]
Goetze, Jens Peter
0000-0001-6356-3829
[1]
[13]
Bakchoul, Tamam
0000-0002-6797-6812
[14]
Nagler, Michael
0000-0003-4319-2367
(Corresponding author)
[2]
[3]
Affiliations
- [1]
Rigshospitalet
[NORA names:
Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
- [2]
University Hospital of Bern
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [3]
University of Bern
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [4]
University Hospital of Zurich
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [5]
University Hospital of Basel
[NORA names:
Switzerland; Europe, Non-EU; OECD];
(... more)
- [6]
University of Greifswald
[NORA names:
Germany; Europe, EU; OECD];
- [7]
Kantonsspital Aarau
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [8]
Institute of Laboratory Medicine and Clinic of Medical Oncology and Hematology, Municipal Hospital Zurich Triemli, Zurich, Switzerland
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [9]
Institute of Oncology Research
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [10]
Fred Hutch Cancer Center
[NORA names:
United States; America, North; OECD];
- [11]
University of Washington
[NORA names:
United States; America, North; OECD];
- [12]
Kantonsspital St. Gallen
[NORA names:
Switzerland; Europe, Non-EU; OECD];
- [13]
University of Copenhagen
[NORA names:
KU University of Copenhagen;
University; Denmark; Europe, EU; Nordic; OECD];
- [14]
Universitätsklinikum Tübingen
[NORA names:
Germany; Europe, EU; OECD]
(less)
Abstract
Importance: Heparin-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.
Objective: To evaluate the current diagnostic practice for managing the suspicion of HIT.
Design, Setting, and Participants: This 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.
Exposures: Suspicion of HIT.
Main Outcomes and Measures: The primary outcome was the diagnostic accuracy of the 4Ts score, the CLIA, and the recommended algorithm serially combining both tests.
Results: Of 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 Relevance: In 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.
Keywords
Germany,
Main,
Main Outcomes,
Switzerland,
United States,
accuracy,
activity,
algorithm,
analysis,
antibodies,
antibody test,
automated chemiluminescence immunoassay,
cardiovascular surgery,
care unit,
center,
chemiluminescence immunoassay,
clarification,
clinical data,
clinical practice,
conclusions,
conditions,
consecutive patients,
data,
delayed diagnosis,
design,
development,
diagnosis,
diagnostic accuracy,
diagnostic algorithm,
diagnostic clarification,
diagnostic practice,
diagnostic studies,
diagnostic study of patients,
diagnostic tests,
diagnostic utility,
false-negative results,
false-positive results,
frequent sets,
heparin-induced platelet activation,
heparin-induced thrombocytopenia,
heparin-induced thrombocytopenia diagnosis,
immunoassay,
information,
intensive care unit,
knowledge,
laboratory information,
life-threatening condition,
low risk,
measurements,
outcomes,
overtreatment,
participants,
patients,
platelet,
platelet activation,
platelet factor 4/heparin antibodies,
practice,
primary outcome,
prospective diagnostic study,
recommendation algorithm,
recommended diagnostic algorithm,
recommended diagnostic tests,
relevance,
results,
risk,
scores,
sets,
state,
study,
study centers,
study of patients,
surgery,
suspected heparin-induced thrombocytopenia,
suspicion,
suspicion of heparin-induced thrombocytopenia,
test,
thrombocytopenia,
units,
utilization
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