Angiomax (bivalirudin) dosing, indications, interactions ... Maria Grana asks, who uses the ecarin clotting test? The activated clotting time (ACT) was monitored 10 minutes after initial bolus and every 15 minutes thereafter. Bivalirudin is a medication used to manage and treat patients undergoing percutaneous coronary intervention for acute myocardial infarction. Therapeutic Monitoring and Titration of Argatroban: a. The intensity of anticoagulation with DTIs depends on the indication for use. ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds. In VALIDATE-SWEDEHEART, 3,005 STEMI patients were randomized equally to bivalirudin or heparin. Radial access was used in 90% of patients, and 87% were treated with a potent P2Y12 inhibitor prior to angioplasty (an oral bolus dose of ticagrelor or prasugrel or parenteral cangrelor); 4.9% and 3.4% of patients in the heparin and bivalirudin arms . If the ACT should fall below the 2.5 threshold the patient can be rebolused with a dose of 0.2 to 0.5 of the initial loading dose. 3 Later, the ACT test was extensively used to monitor UFH therapy in patients undergoing cardiopulmonary bypass surgery or percutaneous . The ACT is performed by adding whole blood to a tube containing a surface activator, either kaolin or diatomaceous earth, which stimulates the contact activation pathway. During and after cardiopulmonary bypass (CPB) conventional activated clotting time (ACT) systems vary significantly in the response to bivalirudin anticoagulation. Cost, turn-around time and 24/7 availability at UWMC . Formulary Anticoagulation Flashcards | Quizlet Laboratory Monitoring of Parenteral Direct Thrombin Inhibitors ACT does not appear to be useful in monitoring of bivalirudin, and while aPTT may be limited by poor linearity and reproducibility, it is the most common monitoring test. If ACT 141-160 sec Increase Heparin infusion by 1 unit/kg/hour If ACT 161-180 sec No change If ACT 181-200 sec Decrease Heparin infusion by 1 unit/kg/hour If ACT 201-220 sec Decrease Heparin infusion by 2 units/kg/hour If ACT greater than 220 sec Notify MD Klinik und Poliklinik - Abt. Anticoagulation during percutaneous coronary intervention (PCI) requires the monitoring of activated clotting time (ACT) to protect from periprocedural ischemic and bleeding complications; however, the optimal ACT values have not been established when PCI is performed with bivalirudin. It has an advantage over aPTT for PCI because, at high doses of heparin, the dose-response relationship remains linear for ACT. At UWMC, bivalirudin is monitored using the Direct Thrombin Inhibitor (DTI) assay (Plasma-Diluted Thrombin Time). 10 Although ACT is a quick, easy, and reliable method of anticoagulation testing that is extremely useful in monitoring heparin . PDF Monitoring the Direct Thrombin Inhibitors Plasma samples were evaluated for bivalirudin by a chromogenic assay at an independent hematological laboratory. ACT does not appear to be useful in monitoring of bivalirudin, and while aPTT may be limited by poor linearity and reproducibility, it is the most common monitoring test. Patients admitted for percutaneous cardiac cath lab procedures routinely undergo arterial puncture and sheath . PDF Procedure for anticoagulation with Heparin For patients ... Bivalirudin and Ecarin Clotting Time | The Fritsma Factor Perioperative care in an adolescent patient with heparin ... The ACT was used for monitoring anticoagulation, and repeated bolus doses of bivalirudin (total 0.9 mg/kg) were required during the first 30 minutes of CPB to achieve the target range of ACT >400 seconds. Anticoagulation with direct thrombin inhibitors during ... Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75mg/kg/h infusion dose is properly administered. Dose: slow IV infusion over 1-3min, Max 50mg over 10min. Bivalirudin is a short‐acting direct thrombin inhibitor that is increasingly used as a replacement for heparin anticoagulation during cardiac surgery in patients diagnosed for HIT. Survey of Anticoagulation Practices with the Impella ... about intraprocedural use of bivalirudin during transcatheter structural heart disease interventions. 25 minutes. An ACT will be obtained at the end of the procedure in the cath lab or the operating room. • Selective, competitive reversible active-site inhibitor of both . There are protocols for both bivalirudin and lepirudin. Kardiologie, Klinikum der Universität München, München; : Introduction: The direct thrombin inhibitor bivalirudin has been approved as new anticoagulant in patients undergoing PCI. Anticoagulation during percutaneous coronary intervention (PCI) requires the monitoring of activated clotting time (ACT) to protect from periprocedural ischemic and bleeding complications; however, the optimal ACT values have not been established when PCI is performed with bivalirudin. Contraindications. 0.15 mg/kg/hr. The most common tests for bivalirudin and argatroban anticoagulation monitoring are aPTT and ACT; however, thrombin time (TT), dilute thrombin time (dTT), chromogenic anti-IIa, and ecarin clotting time (ECT) have also been reported to be used. The facility's protocol includes a bolus dose of 0.75 mg/kg followed by an infu- 1 Clinicians generally counsel patients who experience this potentially life-threatening adverse reaction to never receive heparin again. Appropriate monitoring of DTI effects remains an unresolved issue, especially because the ECT has limited availability. With the development of many alternative (nonheparin) anticoagulants, avoiding heparin in most . Score 0-1 2-3 4-5 6þ use of Edoxaban 15 mg QD resulted in a 4.4%/year absolute risk re-. DTI anticoagulation used during percutaneous coronary intervention can be measured using ACT. Monitoring: APTT baseline, 6h after dose or with each dose change, check daily after 1st day, adjust dose based on results. INR, platelet. Monitor aPTT every 4 hours and titrate Argatroban infusion according to Titration Protocol. ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds. Bivalirudin Initial Dosing. During PCI, monitoring of clotting time such as the ACT is recommended in patients with renal insufficiency. CrCl (ml/min) Bivalirudin Initial dose (mg/kg/hour) > 60 0.15 +/- 0.1 No adjustments were made in bivalirudin infusion rate based on ACT results, in keeping with interventional cardiology practice . Limitations of ACT monitoring of bivalirudin therapy have been demonstrated previously, where the correlation between bivalirudin plasma concentration and activity were not accurately reflected by the ACT value.11 A study of PCI patients treated with bivalirudin studied whether bleeding compli- clotting time (ACT) monitoring. with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h. Objectives . Renal and intravascular proteolysis is the major methods of drug clearance from the body. Duration. Pharmacokinetics. 25, 26 The ACT and the aPTT are the most commonly used monitoring . The risk of hemorrhage increases with bivalirudin plus streptokinase and aspirin. Discontinue bivalirudin when INR greater than 3.0 after an overlap of 5 days of bivalirudin and warfarin (Coumadin) has occured . Monitor ACT every 12 hours after initiation of infusion. Dose: 80U/kg bolus, then 18U/kg/h. Five (5) minutes after the bolus dose has been administered, an ACT (Activated Clotting Time) should be performed and an additional bolus of 0.3 mg/kg should be given if . Bivalirudin exhibits linear pharmacokinetics following IV administration to patients undergoing PTCA. We report a case of bivalirudin use in a patient with type-2 HIT during percutaneous mitral valve repair with the Mitraclip . If the ACT is subtherapeutic (defined as an ACT less than 250 seconds on heparin or less than 300 seconds on bivalirudin), the patient will receive a heparin bolus of 30 units/kg IVP (5000 unit maximum) prior to transfer. A target ACT of 250 to 350 seconds seems to be most often used in interventional practice. 1excessively dosed DTIs to achieve the standard CPB anticoagulation target of an ACT greater than 400 s. As a target value, the safety of 400 s was established for heparin rather than DTI-mediated anticoagulation, using early . Stop bivalirudin infusion at least 15 minutes and up to 60 minutes before planned end of CPB Consider ultrafiltration 30 to 60 minutes prior to going off CPB to remove bivalirudin Once off CPB, move the arterial cannula to the right atrium to minimize the risk of stroke Continue ultrafiltration with ACT monitoring Probability of fall per year 7% 13% 27% 49% duction in stroke (P < 0.001) at the cost of a non-significant absolute. Figure 1 Bivalirudin dosing and relevant ACT in the present patient with HIT. If bivalirudin was given, the sheath may be removed 2 hours following discontinuation of the infusion. BIVALIRUDIN Bivalirudin is typically used for short-term anticoagulation (half-life of 25 min) and is not typically monitored. Maintain aPTT of 60 - 90 seconds c. Follow platelet counts a minimum of every 8 hours 2. If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered. 2013 (N=20 adults) • 50% VA ECMO • 10 heparin vs. 10 bivalirudin cases • Bivalirudin group Ecarin clotting time and chromogenic anti-factor IIa assay are the most reliable methods for DTI monitoring; however, they are not readily available in clinical . Therapeutic Monitoring. The TEG® ECT should prove more useful than the standard ACT for monitoring . If patient has received Low Molecular Weight Heparin (e.g. While the facility has a weight-based pharmacy protocol for bivali-rudin use in anticoagulation medical management, it is not approved for cardiac surgery. The ACT is a clot-based assay that measures either the mobility of a magnet during clot formation or the change in velocity of movement through blood as it clots. Recently, Salemi et al. Used instead of aPTT to monitor injectable DTI therapy. If the patient was on heparin before coming to the lab and ad hoc PCI was to follow, ACT would give some idea of state of anticoagulation while transitioning to bivalirudin. 10 The ACT graded response to heparin concentrations is in the range of 1 U to 5 U/mL. Please use the following for the initial dose of bivalirudin in heparin-induced thrombocytopenia (HIT): Creatinine Clearance (CrCl) T 1/2. Red squares indicate ACT values while the blue dos indicate bivalirudin doses. Can the ecarin clotting test be used for bivalirudin (Angiomax) monitoring? This activity reviews the indications, action, and contraindications for bivalirudin as a valuable agent in the therapy of acute myocardial infarction, in addition to its broader applications in . enoxaparin) the sheath is removed 8 hours following the last dose. Most centers will initially target a lower therapeutic range (aPTT of 1.5-2.0× normal) and increase the target aPTT to 1.5-2.5× normal as necessary for optimal circuit . 7 Although the different ACT assays revealed a good correlation to plasma bivalirudin concentrations . Background This study was a reanalysis of the Bivalirudin Angioplasty Study, which compared bivalirudin with high-dose heparin during coronary angioplasty for unstable angina.Methods Differences in rates of death, myocardial infarction, or repeat revascularization were compared at 7, 90, and 180 days after angioplasty with intention-to-treat analysis. Unfractionated heparin (UFH) has been used clinically as an anticoagulant since 1935. Either increases effects of the other by anticoagulation. Each time the dose is changed, plasma samples for bivalirudin concentration . * The ACT should be monitored in renally-impaired patients Pharmacodynamics: In healthy volunteers and patients (with ≥ 70% vessel occlusion undergoing routine angioplasty), bivalirudin exhibits linear dose- and concentration-dependent anticoagulant activity as evidenced by prolongation of the ACT, aPTT, PT, and TT. However, there is little data on the actual . this trial (conducted in Japan and confined to Japanese patients) the. Bivalirudin: 1.5mg/kg IV bolus, 50mg in prime and maintence of 2.5mg/kg/hr (adjusted .25mg/kg/hr to maintain ACT) Lepirudin: .4mg/kg IV bolus, .15mg/kg/hr infusion to maintain aPTT. Immediate anticoagulant effect. Monitoring: Bivalirudin prolongs the activated clotting time (ACT), activated partial thromboplastic time (aPTT), thrombin time, prothrombin time, and international normalized ratio. 1,2 Thirty-one years later, the activated clotting time (ACT) was developed as a test for the diagnosis and management of patients with inherited coagulation disorders. Activated clotting time (ACT) monitoring during bivalirudin infusion presents some limitations and it is not mandatory. It is in the direct thrombin inhibitor class of drugs. Advantages of Bivalirudin include its short half-life (25 minutes), easy monitoring of anticoagulation using ACT,PT,APTT, thrombin time all of which rise linearly with dosage. Bivalirudin is an intravenous direct thrombin inhibitor that is approved by the FDA for use in patients undergoing PCI. We report a case of bivalirudin use in a patient with type-2 HIT during percutaneous mitral valve repair with the Mitraclip system (Abbott, Abbott Park, Illinois, United States). Setting: A cardiac surgical operating room of a university-affiliated hospital. AE: Bleeding, thrombocytopenia, osteoporosis, hypersensitivity. 1 Increasing demand, technologic advances, and growing expertise have expanded application of ventricular assist devices (VADs) in patients with heart failure when conventional approaches fail. • AT-III Monitoring o Monitored every 12-24 hours or 4 hours after giving a dose o Anti-Xa and/or aPTT should also be evaluated following AT-III administration . Although heart transplantation remains the best option for many, there is a lack of . (A) The dosage of bivalirudin and the ACT monitoring during bivalirudin treatment. After 495 con … clotting time (ACT) monitoring. Careful monitoring of the ACT is important because some patients have persistent thrombin activity despite heparin therapy. A Hemochron Response Whole Blood Coagulation System was used as the point-of-care ACT monitoring device (Accriva Diagnostics, San Diego . • Bivalirudin group remained in ACT and aPTT goal ranges longer • Fewer blood products required by bivalirudin group • Bivalirudin is safe and effective in the setting of ECMO • May result in fewer bleeding complications : Pieri M, et al. To compare the kaolin-activated coagulation time (K-ACT) to the MAX-ACT for monitoring anticoagulation with bivalirudin in patients undergoing hybrid off-pump coronary artery revascularization . 28 However, ACT can be used to monitor LMWH anticoagulation with appropriate adjustments. of argatroban and bivalirudin therapy is relatively short, no attempt is being made to standardize the PTT for DTI monitoring. BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 1 of 41 . Background . Linear regression of the standard ACT versus bivalirudin level gave an r 2 = 0.306 whereas the TEG® ECT gave a much higher r 2 = 0.746 (both P < 0.0001). received bivalirudin. described a novel approach to monitoring bivalirudin activity by using a specific chromogenic antifactor IIa test. Recommended initial infusion rate (based on total body weight) >60 ml/min. Bivalirudin will increase the ACT, but it is not used to guide dosing, just to verify some degree of anticoagulation. 23 Indeed, bivalirudin connotes this bivalent binding to thrombin. However, the heparin regimen should probably be less aggressive (target ACT 200 to 250 seconds) when GP IIb/IIIa inhibitors are used. At a bivalirudin dose of 1 mg/kg IV bolus plus 2.5 mg/kg/h IV infusion for 4 hours, followed by 0.2 mg/kg/h, all patients reached maximal ACT values >300 sec. While the facility has a weight-based pharmacy protocol for bivali-rudin use in anticoagulation medical management, it is not approved for cardiac surgery. Use Caution/Monitor. Ximelagatran • Prodrug administered orally and transformed after absorption into active drug melagatran. Managing anticoagulation in patients being supported by the Impella pVAD is made challenging by several unique features of the device. Preliminary evidence indicates that the ACTT (a modified ACT with improved clotting time linearity to high bivalirudin concentrations) correlates with low and high plasma concentrations of bivalirudin in this setting.74 Additionally, the Thromboelastograph®-based ECT was introduced recently and was found to provide rapid monitoring of . If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered. Once ACT 300-450 is reached, use that dose throughout the procedure Check ACT 5-10 minutes after dosage change, and during prolonged procedures, every 20-30 minutes Additional 150 ug/kg boluses and 40 ug/kg/min may be used if needed to reach ACT goal 350 ug/kg bolus over 3-5 minutes then 25 ug/kg/min Inclusion Criteria: Patients wil be males and non-pregnant females with an age range of 0 up to 16 years of age who are expected to undergo an elective percutaneous iii. - a. PTT for patients with HIT or unstable angina. Monitoring: Request aPTT 4 hours post starting the infusion. Transition to prolonged ECMO (>48 hours) • Check baseline ACT at the time of decision of converting to longterm ECMO- anticoagulation with bivalirudin • Stop heparin infusion However, pharmacokinetic studies during cardiac surgery are only available for bivalirudin. The ACT should be checked at 5 minutes post bolus dose. The bivalirudin infusion was initiated following induction of anesthesia. Anticoagulation with unfractionated heparin during extracorporeal membrane oxygenation (ECMO) is common, but alternative agents are being evaluated for safety and efficacy. Bivalirudin: therapeutic anticoagulation Due to the liver injury that may be seen in patients with COVID-19, bivalirudin is the preferred direct thrombin inhibitor for the treatment of HIT, enoxaparin failure, or patients receiving extracorporeal membrane oxygenation (ECMO). 4. (B) The linear relationship between bivalirudin dosage and ACT value undergoing ECMO with CRRT. 30-60 ml/min. Bivalirudin Pharmacokinetics Absorption Onset. The ACT may be used to assess argatroban or bivalirudin during PCI or coronary artery bypass graft surgery.13 During these procedures, the target ACT is 320-400 seconds (RI 90-175 seconds). For patients with HIT, the target aPTT is 1.5 to 3.0 and 1.5 to 2.5 times the patient's baseline value for argatroban and bivalirudin, respectively. Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg/h infusion dose is properly administered. Most centers will initially target a lower therapeutic range (aPTT of 1.5-2.0× normal) and increase the target aPTT to 1.5-2.5× normal as necessary for optimal circuit . Administration of bivalirudin leads to a reproducible, immediate anticoagulant effect with elevation of activated partial thromboplastin time (aPTT), thrombin time, activated clotting time (ACT), and to a lesser extent prothrombin time and international normalized ratio values. 3. It is suggested that bivalirudin can be managed using a dosing protocol to provide anticoagulation therapy to patients during ECMO and can provide foundational guidance for dose adjustment and monitoring for other institutions. In regard to dosing of bivalirudin, it is clear that initial and maintenance infusion rates varied significantly between studies, even when targeting similar aPTT and ACT targets. Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg/h infusion dose is properly administered. If the 5-minute ACT is less than 225 seconds, a second bolus dose of .3mg/kg should be administered. ACT would be documentary, but not diagnostic. Preferred over aPTT due to better sensitivity, and is not affected by antiphospholipid antibodies. - ACT for patients undergoing CABG. The activated clotting time (ACT) can be used for point-of-care monitoring during procedures. Activated clotting time (ACT) monitoring during bivalirudin infusion pre-sents some limitations and it is not mandatory. If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered. monitoring to attain the clinically desired range of 1.5-2.5 times the baseline value. An ACT will be obtained at the end of the procedure in the cath lab or the operating room. Their study revealed that antifactor IIa assay appropriately shows decreasing bivalirudin plasma levels, while ACT levels remain elevated for an extended period of time. Coagulation times return to normal approximately 1-2 hours after cessation of infusion. In recent years, several reports have been published describing the use of various clotting tests including various ACTs, the plasma-modified ACT, the HiTT, and the ECT for monitoring levels used in cardiac surgery of the direct thrombin inhibitors hirudin and bivalirudin (7,8,11,13,17-20). Fetal risk in pregnancy cannot be ruled out. Objective: To compare the kaolin-activated coagulation time (K-ACT) to the MAX-ACT for monitoring anticoagulation with bivalirudin in patients undergoing hybrid off-pump coronary artery revascularization procedures. ACT is determined predominantly by the anti-IIa activity of the anticoagulant. ACT warrants an additional bolus. If hemoconcentrating the patient then monitor the ACT every 15 minutes as the hemoconcentrator does remove bivalirudin. Angiomax® (bivalirudin) • Monitoring - ACT for patients undergoing PTCA. and ACT wil be collected at steady state or just before discontinuation of . Our institutional protocol has been to use K-ACTs for bivalirudin anticoagulation cases based on published experience of other groups using this test to monitor bivalirudin anticoagulation during bypass (8,9). Design: A prospective, observational study. 29,30 2. Monitor the ACT every thirty minutes unless the patient is being hemoconcentrated. To characterize anticoagulation practices with the Impella percutaneous ventricular assist device (pVAD). We use bivalirudin or lepirudin. Notify physician if ACT >200 b. ACT was confirmed to be greater than 300 seconds before proceeding with transseptal puncture. Protamine sulfate. The bivalirudin infusion was initiated following induction of anesthesia. The number of children and adults with end-stage heart failure is increasing, although the etiologies are different. Hemin degradation product (ie, hematin) may produce coagulopathy (eg, thrombocytopenia, platelet degranulation) and cause mild anticoagulant effects. the . 2. PROVIDER INITIAL: _____ Page 3 of 3 Bivalirudin Orders and Dosing Protocol for Heparin-Induced Thrombocytopenia (HIT) [30400913] 913 Target aPTT is 1.5-2.5 times baseline value (see below for select Can these patients have antithrombin (AT, ATIII) deficiency? Active of major bleeding; Hypersensitivity to bivalirudin or its components; Monitoring. Monitor Closely (1) bivalirudin, hemin. It has been hypothesized that the targeted effects of bivalirudin may result in more consistent anticoagulation . bivalirudin. Heparin-induced thrombocytopenia (HIT) is a highly prothrombotic state resulting from pathogenic antibodies to platelet factor 4/heparin (PF4/H) complexes. ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds. We are having complaints from MDs that the activated clotting time (ACT) is not responding to administration of heparin on some patients. bivalirudin infusion. Activated clotting time (ACT): 5 minutes after the initial bolus The bolus dose should not be changed from the posology described under ACS or PCI above. If the ACT is subtherapeutic (defined as an ACT less than 250 seconds on heparin or less than 300 seconds on bivalirudin), the patient will receive a heparin bolus of 30 units/kg IVP (5000 unit maximum) prior to transfer. As a result, frequent monitoring of the activated clotting time (ACT) must occur when using heparin during PCI. In this case, bivalirudin was initiated as a 0.5 mg/kg bolus followed by a continuous infusion of 0.5 mg/kg/h to maintain an ACT of 200-220 s . Bivalirudin ACT during PCI min after bolus >225 sec Prior to start, 5-10 dosing and change in infusion rate, and at end of procedure Monitoring required for all patients If the ACT <225 sec, an additional IV bolus of 0.3 mg/kg should be administered aPTT Monitoring required for 1.5-2.5 times baseline aPTT 2 h after start of infusion and each Commonly used monitoring ) the linear relationship between bivalirudin dosage and ACT value is than. Dose is properly administered ACT for monitoring the sheath is removed 8 hours following last. Of clotting time when... < /a > bivalirudin Initial Dosing these include the of. To monitor injectable DTI therapy after cardiopulmonary bypass ( CPB ) conventional activated clotting time ACT... 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