Heparin-Induced Thrombocytopenia

Greinacher, Andreas

doi:10.1056/nejmcp1411910

Cited by 525 publications

(549 citation statements)

References 53 publications

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“…HIT is characterized by immunoglobulin G antibodies against platelet factor 4 (PF4)-heparin complexes which trigger a highly prothrombotic state through intravascular platelet aggregation, intense platelet activation, and excessive thrombin generation. 1 The diagnosis of HIT is based on a significant decrease in the platelet count with or without venous or arterial thrombosis combined with serologic evidence of HIT antibodies in patients exposed to unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). [2][3][4] Treatment of HIT involves discontinuing all forms of heparin and administering an alternative nonheparin anticoagulant.…”

Section: Introductionmentioning

confidence: 99%

Reducing the hospital burden of heparin-induced thrombocytopenia: impact of an avoid-heparin program

McGowan

Makari

Diamantouros

et al. 2016

Blood

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Key Points• Use of LMWH is associated with a lower risk of HIT and HITT compared with use of UFH.• The Avoid-Heparin Initiative resulted in a dramatic reduction in the burden of suspected HIT, adjudicated HIT, HITT, and associated costs.Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction occurring in up to 5% of patients exposed to unfractionated heparin (UFH). We examined the impact of a hospital-wide strategy for avoiding heparin on the incidence of HIT, HIT with thrombosis (HITT), and HIT-related costs. The Avoid-Heparin Initiative, implemented at a tertiary care hospital in Toronto, Ontario, Canada, since 2006, involved replacing UFH with lowmolecular-weight heparin (LMWH) for prophylactic and therapeutic indications. Consecutive cases with suspected HIT from 2003 through 2012 were reviewed. Rates of suspected HIT, adjudicated HIT, and HITT, along with HIT-related expenditures were compared in the pre-intervention (2003)(2004)(2005) and the avoid-heparin (2007)(2008)(2009)(2010)(2011)(2012) phases. The annual rate of suspected HIT decreased 42%, from 85.5 per 10 000 admissions in the pre-intervention phase to 49.0 per 10 000 admissions in the avoidheparin phase (P < .001). The annual rate of patients with a positive HIT assay decreased 63% from 16.5 to 6.1 per 10 000 admissions (P < .001), adjudicated HIT decreased 79% from 10.7 to 2.2 per 10 000 admissions (P < .001), and HITT decreased 91% from 4.6 to 0.4 per 10 000 admissions (P < .001). Hospital HIT-related expenditures decreased by $266 938 per year in the avoid-heparin phase. To the best of our knowledge, this is the first study demonstrating the success and feasibility of a hospital-wide HIT prevention strategy. (Blood. 2016;127(16):1954-1959

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Section: Introductionmentioning

confidence: 99%

Reducing the hospital burden of heparin-induced thrombocytopenia: impact of an avoid-heparin program

McGowan

Makari

Diamantouros

et al. 2016

Blood

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“…Although we acknowledge that fondaparinux is not a standard therapy for HIT among individuals with a creatinine clearance below 30 mL/min, it was used as first‐line therapy in this patient because of the restricted access to argatroban in a resource‐limited country such as ours. After switching to apixaban a prompt normalization of the platelet count followed, which is the strongest clinical indicator of recovery among patients with HIT 1. Furthermore, the patient did not experience any bleeding events and no further thrombotic episodes took place.…”

Section: Discussionmentioning

confidence: 79%

“…Heparin‐induced thrombocytopenia (HIT) is a prothrombotic state that affects roughly 1 in 5000 hospitalized patients and is caused by antibodies directed against platelet factor 4–heparin complexes 1. The diagnosis of HIT is based on a combination of clinical criteria and laboratory tests.…”

Section: Introductionmentioning

confidence: 99%

“…Treatment involves suspension of all forms of heparin and institution of an alternative anticoagulant 2. HIT is more commonly seen after exposure to unfractionated heparin (UFH) than after exposure to other heparin formulations, so patients with chronic kidney disease (CKD) on hemodialysis (HD) are at risk of developing this condition 1. Argatroban is the recommended therapy for individuals with HIT and renal failure.…”

Section: Introductionmentioning

confidence: 99%

“…Argatroban is the recommended therapy for individuals with HIT and renal failure. Unfortunately, this medication must be administered as a continuous infusion and is not widely available everywhere 1, 2. Hence, treatment options for patients with diminished renal function and HIT are limited.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Successful treatment of heparin‐induced thrombocytopenia with apixaban in a patient with chronic kidney disease requiring hemodialysis

Agudelo

Quintero

Barrientos

2018

Clinical Case Reports

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Unexpected Heparin-Induced Thrombocytopenia While Bridging

Uzoigwe¹,

Franco

Ali

2020

JAMA Intern Med

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32.9%), and the remaining 130 of 194 (67.0%) were subsequent uses of the surrogate. The number of unique surrogate measure-cancer combinations accepted for drug approval has increased over time between 1992 and 2019 (Figure), to as many as 70 (36.1%) from 2016 through 2019 (Table ). Most of these combinations had unknown postmarketing OS data (Table ).When examining the strength of correlation between the surrogate end point and OS among the 64 first-surrogate-based approvals, we found that 39 (61%) had no documented correlation, 10 (16%) had a poor correlation (r ≤ 0.7), 1 (2%) had a medium correlation (0.70 < r <0.85), and only 3 (5%) had a high correlation (r ≥ 0.85). Eleven approvals (17%) had varied levels of correlation across multiple validation studies. Among the 49 approvals with low or unknown correlation, 23 (47%) were accelerated approvals, and 26 (53%) were regular approvals.Discussion | The FDA has used surrogate end points approximately 194 times to approve cancer drugs since 1992, and about 1 in 3 times, a surrogate was used for the first time in a particular type of cancer. When this is the case, the strength of association between the surrogate end point and OS is often absent or weak. This means that the FDA's use of these surrogate measures is justified neither by strength of association (ie, ability to predict gains in OS) nor previous first use, since 1 in 3 approvals constitute the use of a surrogate end point for the first time in the treament of a specific cancer type. Our study is limited by some missing FDA label updates before 2006 that are not publicly accessible.Surrogate end points can expedite trial completion compared with OS, 4 but they add substantial uncertainty regarding whether the drugs involved improve quantity or quality of life. 6 Moreover, the FDA rarely demands stringent confirmation of clinical benefit following market approval. 3 We find that the FDA is steadily accepting more surrogate measures over time, which are not justified by scientific validity or adherence to regulatory precedent. This reflects a greater tolerance of risk, and if postmarketing studies are slow, incomplete, or demonstrate negative results, then patients experience harm and cost without the intended benefit.

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Heparin-Induced Thrombocytopenia

Cited by 525 publications

References 53 publications

Reducing the hospital burden of heparin-induced thrombocytopenia: impact of an avoid-heparin program

Reducing the hospital burden of heparin-induced thrombocytopenia: impact of an avoid-heparin program

Successful treatment of heparin‐induced thrombocytopenia with apixaban in a patient with chronic kidney disease requiring hemodialysis

Unexpected Heparin-Induced Thrombocytopenia While Bridging

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