Regression Analysis to Estimate the Factor VIII Activity of Patients with Hemophilia A Without Inhibitor who Received Emicizumab Therapy

Hatayama, Yuki; Motokura, Toru; Hosoda, Yuzuru; Suzuki, Shinya; Namba, Hiroya; Kato, Konami; Kojima, Nao; Horie, Takuya; Iwamoto, Takuya; Yamashita, Noriko; Ichikawa, Hitomi; Fukuda, Tetsuya

doi:10.1177/10760296221082992

Cited by 5 publications

(7 citation statements)

References 28 publications

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“…73 Another study using modified clot waveform analysis (CWA) showed the equivalent FVIII activity of ~15 IU/dL of emicizumab during the maintenance phase of treatment. 74…”

Section: Section 1: General Considerationsmentioning

confidence: 99%

Antithrombotic Treatment in Patients With Hemophilia: an EHA-ISTH-EAHAD-ESO Clinical Practice Guidance

et al. 2023

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Cardiovascular disease is an emerging medical issue in patients with hemophilia (PWH) and its prevalence is increasing up to 15% in PWH in the United States. Atrial fibrillation, acute and chronic coronary syndromes, venous thromboembolism, and cerebral thrombosis are frequent thrombotic or prothrombotic situations, which require a careful approach to fine-tune the delicate balance between thrombosis and hemostasis in PWH when using both procoagulant and anticoagulant treatments. Generally, PWH could be considered as being naturally anticoagulated when clotting factors are <20 IU/dL, but specific recommendations in patients with very low levels according to the different clinical situations are lacking and mainly based on the anecdotal series. For PWH with baseline clotting factor levels >20 IU/dL in need for any form of antithrombotic therapy, usually treatment without additional clotting factor prophylaxis could be used, but careful monitoring for bleeding is recommended. For antiplatelet treatment, this threshold could be lower with single-antiplatelet agent, but again factor level should be at least 20 IU/dL for dual antiplatelet treatment. In this complex growing scenario, the European Hematology Association in collaboration with the International Society on Thrombosis and Haemostasis, the European Association for Hemophilia and Allied Disorders, the European Stroke Organization, and a representative of the European Society of Cardiology Working Group on Thrombosis has produced this current guidance document to provide clinical practice recommendations for health care providers who care for PWH.

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“…73 Another study using modified clot waveform analysis (CWA) showed the equivalent FVIII activity of ~15 IU/dL of emicizumab during the maintenance phase of treatment. 74…”

Section: Section 1: General Considerationsmentioning

confidence: 99%

Antithrombotic Treatment in Patients With Hemophilia: an EHA-ISTH-EAHAD-ESO Clinical Practice Guidance

et al. 2023

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“…Some trials have comprehensively used CWA to predict hemostatic effects in emicizumab prophylaxis. 7,18,19 Further, CWA can be used to obtain specific parameters even in infections without disseminated intravascular coagulation (DIC), to distinguish bacterial or viral infection and facilitate selection and early administration of optimal antibiotics for each infection 20 ; moreover, CWA has been associated with the diagnosis of COVID-19, pathological conditions, and prognosis prediction. 21,22 CWA can reflect the entire process of clot formation and is expected to be clinically applied for the differential diagnosis of diseases, severity determination, prognosis prediction, and treatment monitoring in the future.…”

Section: Discussionmentioning

confidence: 99%

Differences in the Composition of Activated Partial Thromboplastin Time (APTT) Reagents Affect Clot Waveform Analysis

et al. 2022

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Background Clot waveform analysis (CWA) based on activated partial thromboplastin time (APTT) is a useful assay for hemostasis. However, the effects of activators and phospholipid conditions on CWA have not been adequately investigated. Therefore, we characterized CWA using four different APTT reagents. Methods We used 39 archived plasma samples from patients with hemophilia A (HA), 16 samples from patients with HA under emicizumab treatment, and 10 samples from healthy individuals for CWA with four different types of APTT reagents (reagents A, B, C, and D). We then compared Ad|min1|, Ad|min2|, and Ad|max2| from the CWA, which reflect the maximum velocity, maximum acceleration, and maximum deceleration, respectively, among the four reagents. Results Similar clot waveform shapes were observed for each reagent in the healthy donor group, HA group, and HA under emicizumab group, and the waveform was different for each target group. Significant changes were found in clotting time (CT) (s), Ad|min1| (%/s), Ad|min2| (%/s 2 ), and Ad|max2| (%/s 2 ). The waveform pattern for the coagulation reaction by reagent D, comprising silica and synthetic phospholipids, was the slowest among the reagents examined. Further, the difference in Ad|min1| (%/s) and Ad|min2| (%/s 2 ) was larger than that in CT depending on the reagent used(s), indicating that the measured value of CWA was affected by the reagent composition. Conclusion Our results showed a significant difference among reagents with varying composition and concentration; this was found to affect the parameters obtained from CWA. Thus, the differences between reagents hinder standardization of quantitative evaluation using these parameters; further, this highlights the necessity of understanding the characteristics of APTT reagents and determining the reference range in individual facilities.

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“…Some trials have comprehensively used CWA to predict hemostatic effects in emicizumab prophylaxis. 7,17,18 Further, CWA can be used to obtain specific parameters even in infections without disseminated intravascular coagulation (DIC), to distinguish bacterial or viral infection and facilitate selection and early administration of optimal antibiotics for each infection 19 ; moreover, CWA has been associated with the diagnosis of COVID-19, pathological conditions, and prognosis prediction. 20,21 CWA can reflect the entire process of clot formation and is expected to be clinically applied for the differential diagnosis of diseases, severity determination, prognosis prediction, and treatment monitoring in the future.…”

Section: Discussionmentioning

confidence: 99%

Differences in the Composition of Activated Partial Thromboplastin Time (APTT) Reagents Affect Clot Waveform Analysis

et al. 2022

Self Cite

View full text Add to dashboard Cite

Background Clot waveform analysis (CWA) based on activated partial thromboplastin time (APTT) is a useful assay for hemostasis. However, the effects of activators and phospholipid conditions on CWA have not been adequately investigated. Therefore, we characterized CWA using four different APTT reagents. Methods We used 39 archived plasma samples from patients with hemophilia A (HA), 16 samples from patients with HA under emicizumab treatment, and 10 samples from healthy individuals for CWA with four different types of APTT reagents (reagents A, B, C, and D). We then compared Ad|min1|, Ad|min2|, and Ad|max2| from the CWA, which reflect the maximum velocity, maximum acceleration, and maximum deceleration, respectively, among the four reagents. Results Similar clot waveform shapes were observed for each reagent in the healthy donor group, HA group, and HA under emicizumab group, and the waveform was different for each target group. Significant changes were found in clotting time (CT) (s), Ad|min1| (%/s), Ad|min2| (%/s 2 ), and Ad|max2| (%/s 2 ). The waveform pattern for the coagulation reaction by reagent D, comprising silica and synthetic phospholipids, was the fastest among the reagents examined. Further, the difference in Ad|min1| (%/s) and Ad|min2| (%/s 2 ) was larger than that in CT depending on the reagent used(s), indicating that the measured value of CWA was affected by the reagent composition. Conclusion Our results showed a significant difference among reagents with varying composition and concentration; this was found to affect the parameters obtained from CWA. Thus, the differences between reagents hinder standardization of quantitative evaluation using these parameters; further, this highlights the necessity of understanding the characteristics of APTT reagents and determining the reference range in individual facilities.

show abstract

Regression Analysis to Estimate the Factor VIII Activity of Patients with Hemophilia A Without Inhibitor who Received Emicizumab Therapy

Cited by 5 publications

References 28 publications

Antithrombotic Treatment in Patients With Hemophilia: an EHA-ISTH-EAHAD-ESO Clinical Practice Guidance

Antithrombotic Treatment in Patients With Hemophilia: an EHA-ISTH-EAHAD-ESO Clinical Practice Guidance

Differences in the Composition of Activated Partial Thromboplastin Time (APTT) Reagents Affect Clot Waveform Analysis

Differences in the Composition of Activated Partial Thromboplastin Time (APTT) Reagents Affect Clot Waveform Analysis

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