Development and implementation of a nurse-driven, sliding-scale nomogram for bivalirudin in the management of heparin-induced thrombocytopenia

Burcham, Pamela; Abel, Erik; Gerlach, Anthony T.; Murphy, Claire V.; Belcher, Marcia J.; Blais, Danielle

doi:10.2146/ajhp120246

Cited by 6 publications

(11 citation statements)

References 45 publications

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“…To our knowledge, this is the first study to describe characteristics of patients with subtherapeutic anticoagulation with bivalirudin. In the literature, the average time to achieve therapeutic aPTT ranges from 5.5 to 31.8 hours, similar to our cohort . Approximately 50–60% of patients treated with bivalirudin achieve a therapeutic aPTT with the initial dose and require minimal dose adjustments to achieve and maintain steady‐state anticoagulation .…”

Section: Discussionsupporting

confidence: 77%

“…In addition, bivalirudin has been increasingly used as an alternative anticoagulant in scenarios other than HIT, such as perceived refractoriness to heparin therapy. Based on the available literature, our institution developed a bivalirudin dosing protocol previously validated in a critically ill population (Table ) . This protocol was subsequently adopted across various patient populations; however, the validity of this intensive care unit (ICU)‐driven protocol in other inpatient populations has not been established.…”

Section: Bivalirudin Protocolmentioning

confidence: 99%

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Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study

et al. 2019

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BACKGROUND Bivalirudin, a direct thrombin inhibitor, is a treatment option for the management of heparin-induced thrombocytopenia (HIT) and other coagulation disorders. To date, no published studies have identified patients at risk for or the consequence of subtherapeutic bivalirudin therapy. OBJECTIVES The primary objective was to identify factors associated with failure to achieve early therapeutic anticoagulation (ETA) with bivalirudin, defined as achievement of two consecutive therapeutic activated partial thromboplastin times (aPTTs) within 24 hours. Secondary objectives included evaluating whether failure to achieve ETA was a risk factor for clinical outcomes of interest including thromboembolism, hemorrhage, and mortality. PATIENTS/METHODS This was a retrospective cohort study. Patients between the ages of 18 and 89 years treated with bivalirudin for 24 hours or longer were identified and classified as either achieving or failing to achieve ETA. RESULTS Nonadherence to the dosing protocol (odds ratio [OR] 1.7, 95% confidence interval [CI] 1.07-2.71) and creatinine clearance (CrCl) of 60 ml/min or greater (OR 2.99, 95% CI 1.12-7.97) were significantly associated with failure to achieve ETA in univariate analyses. Conversely, increasing age (OR 0.98, 95% CI 0.97-0.99) was significantly associated with achievement of ETA. Failure to achieve ETA was associated with a 4-fold increase in the odds of thromboembolism. CONCLUSIONS Younger age, normal renal function, and nonadherence to the dosing protocol when targeting therapeutic anticoagulation is associated with increased risk of failure to achieve ETA. This confers an elevated risk of thromboembolism when using bivalirudin for the management of HIT or other coagulation disorders.

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Section: Discussionsupporting

confidence: 77%

Section: Bivalirudin Protocolmentioning

confidence: 99%

Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study

et al. 2019

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“…In medically managed HIT, bivalirudin can be expected to achieve therapeutic anticoagulation within a few hours at doses much lower than those required by these 3 patients. 5–7 Also noteworthy was the dramatic increase in INR that occurred upon attainment of a therapeutic aPTT in the first and third case. Although bivalirudin is expected to increase INR, this effect is typically less pronounced compared to other DTIs and the INR rarely exceeds 4.0 during warfarin cotherapy.…”

Section: Discussionmentioning

confidence: 97%

“…[3][4][5] In studies of bivalirudin in medically managed HIT, therapeutic aPTT is typically achieved within 5 to 12 hours. [5][6][7] Often the first aPTT after initiation is within the therapeutic range. 5 In addition to prolonging the aPTT, DTIs are known to prolong the international normalized ratio (INR), making the transition to warfarin challenging.…”

mentioning

confidence: 99%

“…1 Typically, the initial infusion rate is 0.06 to 0.15 mg/kg/h and is titrated to maintain an activated partial thromboplastin time (aPTT) of 1.5 to 2.5 times baseline. [3][4][5][6][7] The initial infusion rate is adjusted in patients with renal insufficiency. [3][4][5] In studies of bivalirudin in medically managed HIT, therapeutic aPTT is typically achieved within 5 to 12 hours.…”

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confidence: 99%

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Direct Thrombin Inhibitor Resistance and Possible Mechanisms

Cardinale

Liu

et al. 2016

Hosp Pharm

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To report 3 cases in which doses of bivalirudin higher than commonly used in clinical practice were required in order to achieve therapeutic anticoagulation as monitored by the activated partial thromboplastin time (aPTT). The medical records of 3 patients who required large doses of bivalirudin to remain therapeutic were thoroughly reviewed. In all 3 patients, bivalirudin was initiated at a rate appropriate for the patients' renal function and titrated using a nurse-driven protocol with recommended dose adjustments based on aPTT. Indications for bivalirudin were anticoagulation in intra-aortic balloon pump, treatment of deep vein thrombosis, and heparin-induced thrombocytopenia with thrombosis. Target aPTT was achieved between 25.5 and 134 hours after initiation despite appropriate titration intervals per protocol. Bivalirudin is a direct thrombin inhibitor frequently used off-label for the medical management of heparin-induced thrombocytopenia. It typically exhibits predictable, dose-dependent anticoagulation. Heparin-induced thrombocytopenia was suspected in 2 of the 3 cases and confirmed in 1. In all 3 patients, target aPTT was initially achieved with doses between 0.456 and 1.0 mg/kg/h after a median of 30.7 hours; up to 1.8 mg/kg/h was required to maintain therapeutic aPTT. In 2 of the cases, the international normalized ratio also increased unexpectedly upon achievement of therapeutic aPTT values. Direct thrombin inhibitors may be subject to resistance mechanisms similar to those previously described in patients receiving heparin. The anticoagulation status of these patients remains unknown.

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Practical Pharmacokinetics and Pharmacodynamics

Gerlach

Saliba

2016

Principles of Adult Surgical Critical Care

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Development and implementation of a nurse-driven, sliding-scale nomogram for bivalirudin in the management of heparin-induced thrombocytopenia

Abstract: A nurse-driven, sliding-scale nomogram for bivalirudin therapy in patients with HIT provided a simple dosing protocol and resulted in a high rate of adherence by nurses.

Cited by 6 publications

References 45 publications

Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study

Risk Factors and Outcomes Associated with Prolonged Subtherapeutic Anticoagulation with Bivalirudin: A Retrospective Cohort Study

Direct Thrombin Inhibitor Resistance and Possible Mechanisms

Practical Pharmacokinetics and Pharmacodynamics

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