Effect of Dabigatran on Clotting Time in the Clotpro Ecarin Clotting Assay: A Prospective, Single-Arm, Open-Label Study

Fong, Alan Yean Yip; Tiong, Lee Len; Tan, S.S.N.; Geruka, Dominic; Apil, Gerald Grino; Choo, Chee Wei; Ong, Tiong Kiam

doi:10.1177/1076029620972473

Cited by 10 publications

(16 citation statements)

References 29 publications

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“…The cup rotation is increasingly resisted and reduced depending on elastic properties of the formed clot. 16,17 between the activity of PAI-1 and lysis time of the formed clot (r ¼ 0.70, p ¼ 0.0006) was observed. Conclusion Our data suggest that severe SARS-CoV-2 infection is associated with impaired fibrinolytic activity in blood, where fibrinolytic inhibitors are elevated leading to an increased resistance to clot lysis.…”

Section: Thromboelastographic Assaysmentioning

confidence: 86%

Severe SARS-CoV-2 Infection Inhibits Fibrinolysis Leading to Changes in Viscoelastic Properties of Blood Clot: A Descriptive Study of Fibrinolysis in COVID-19

Hammer¹,

Häberle

Schlensak

et al. 2021

Thromb Haemost

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Background: Accumulating evidence indicates towards an association between SARS-CoV-2 infection and procoagulatory state in blood. Thromboelastographic investigations are useful point-of-care devices to assess coagulation and fibrinolysis. Objectives: We investigated the hypothesis that the procoagulatory state in COVID-19 patients is caused by impaired fibrinolysis system. Methods: COVID-19 patients admitted to normal wards or to the intensive care unit (ICU) were included in the study. Whole blood samples were investigated by thromboelastography. Additionally, global parameters of coagulation and factors of fibrinolysis as plasminogen activator inhibitor-1 (PAI-1), tissue plasminogen activator (tPA), plasminogen activity and alpha 2-antiplasmin (A2AP) were determined. Results and conclusion: A significantly increased lysis-resistance and a significantly longer time of lysis after adding tissue plasminogen activator was observed in blood samples from ICU COVID-19 patients compared to controls (maximal lysis: 3.25% ± 0.56 vs. 6.20% ± 0.89, p=0.0127; lysis time: 365.7s ± 44.6 vs. 193.2s ± 16.3, p=0.0014). PAI-1 activity was significantly higher in plasma samples of ICU COVID-19 patients (PAI-1: 4.92U/ml ± 0.91 vs. 1.28U/ml ± 0.33, p=0.001). Interestingly, a positively correlation between the activity of PAI-1 and the lysis time of the formed clot (r=0.7015, p=0.0006) was observed. Our data suggest that severe SARS-CoV-2 infection is associated with impaired fibrinolytic activity in blood, where fibrinolytic inhibitors are elevated leading to an increased resistance to clot lysis. Future clinical studies should address the contribution of the fibrinolysis system to the procoagulatory state in blood of COVID-19 patients and investigate potential therapeutic targets in this system.

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Section: Thromboelastographic Assaysmentioning

confidence: 86%

Severe SARS-CoV-2 Infection Inhibits Fibrinolysis Leading to Changes in Viscoelastic Properties of Blood Clot: A Descriptive Study of Fibrinolysis in COVID-19

Hammer¹,

Häberle

Schlensak

et al. 2021

Thromb Haemost

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“…Six out of the 14 studies measured dabigatran concentrations with validated LC-MS/MS method. [36][37][38][39][40][41] Linearity was assessed in 4 studies, 36,[38][39][40] while specificity test was conducted in 2 studies by spiking the citrated plasma pool with dabigatran to prepare 6 calibration standards. 40,41 Accuracy and precision were assessed in 2 studies and were in-line with the guidance of FDA stating the accuracy and precision should be within 15%.…”

Section: Search Results and Study Characteristicsmentioning

confidence: 99%

“…40,41 Accuracy and precision were assessed in 2 studies and were in-line with the guidance of FDA stating the accuracy and precision should be within 15%. 38,40 One of them reported only using validated LC-MS/MS method without further details. 37 Eight studies 34,[42][43][44][45][46][47][48] with a total of 630 patients did not provide details on the method validation, which may raise risk of bias.…”

Section: Search Results and Study Characteristicsmentioning

confidence: 99%

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Tahir

Chin

et al. 2022

Brit J Clinical Pharma

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Dabigatran etexilate is an oral direct thrombin inhibitor used in preventing thromboembolism in patients with atrial fibrillation and several other conditions. Routine dabigatran concentration monitoring is not recommended in clinical practice; however, measurement of dabigatran concentration may be required in several conditions. This study aims to pool the peak and trough dabigatran concentration from real‐world studies. A systematic review was performed to identify studies that measured the peak and trough dabigatran concentrations. Observational studies reporting dabigatran peak or trough concentrations and patients' clinical characteristics of either sex, age or weight were included. Random‐effect meta‐analyses and metaregression were conducted to pool dabigatran concentrations and to identify the correlation between factors affecting dabigatran concentrations. Fifteen studies with a total of 1226 patients were included. The pooled peak dabigatran concentration was 133 ng/mL (95% CI: 113–154, I2 = 86%, n = 655), while the pooled dabigatran trough concentration was 80 ng/mL (95% CI: 69–91, I2 = 93%, n = 1010). Metaregression analyses suggested that age is significantly correlated to trough concentration, while body weight and creatinine clearance significantly correlated to peak concentration. Subgroup results revealed that dabigatran concentration when measured with liquid chromatography–tandem mass spectrometry was higher than haemoclot thrombin inhibitor assay. Several guidelines have proposed dabigatran concentrations target range and the pooled dabigatran concentrations were in line with the suggested range. Further studies to correlate dabigatran concentrations and clinical outcomes is warranted to improve the safety and efficacy monitoring of dabigatran therapy.

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“…Considering the coagulation cascade, it could be also affected by anti-thrombin drugs, such as argatroban or dabigatran, or by hypofibrinogenemia. Thus, we also estimated anti-thrombin activity with the ECA and examined the plasma fibrinogen level [ 5 ]. The results were consistently in the normal range during the perioperative period, confirming that the prolongation of CT in the RVV test reflected anti-Xa activity owing to apixaban.…”

Section: Discussionmentioning

confidence: 99%

“…We examined blood cell count, PT, APTT, and plasma fibrinogen level at four time points: after anesthesia induction, at the end of surgery, on postoperative day (POD) 1, and on POD 6. We simultaneously performed the ClotPro assay, an ecarin chromogenic assay (ECA), to detect the effect of direct thrombin inhibitors such as dabigatran [ 5 ], and a fibrinogen concentration assay. Blood samples for outsourced chromogenic anti-Xa assay were collected at the same time points.…”

Section: Case Presentationmentioning

confidence: 99%

Evaluation of the effect of apixaban using a viscoelastic coagulation assay with Russell’s viper venom reagent

et al. 2021

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Background Conventional coagulation tests, such as prothrombin time and activated partial thromboplastin time, are not sensitive to anticoagulation by apixaban. We evaluated the antithrombotic effect of apixaban using a Russell viper venom (RVV) test for a patient who underwent posterior spine fusion surgery. Case presentation An 84-year-old man was scheduled for percutaneous posterior spine fusion. He continued apixaban until the night before surgery and resumed it on the first day after surgery. We performed an RVV test as point-of-care coagulation monitoring in combination with chromogenic anti-activated factor X (anti-Xa) activity, prothrombin time, and activated partial thromboplastin time. Clotting time with the RVV test was prolonged according to the anti-Xa activity of apixaban, which was in the therapeutic range during surgery. Conclusions An RVV test might be useful as a point-of-care assay for estimation of the anti-Xa level induced by apixaban during the perioperative period.

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Effect of Dabigatran on Clotting Time in the Clotpro Ecarin Clotting Assay: A Prospective, Single-Arm, Open-Label Study

Cited by 10 publications

References 29 publications

Severe SARS-CoV-2 Infection Inhibits Fibrinolysis Leading to Changes in Viscoelastic Properties of Blood Clot: A Descriptive Study of Fibrinolysis in COVID-19

Severe SARS-CoV-2 Infection Inhibits Fibrinolysis Leading to Changes in Viscoelastic Properties of Blood Clot: A Descriptive Study of Fibrinolysis in COVID-19

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Evaluation of the effect of apixaban using a viscoelastic coagulation assay with Russell’s viper venom reagent

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