bivalirudin / Generic mfg. - LARVOL DELTA

Anticoagulation and hemostasis in the extracorporeal membrane oxygenation patient. (PubMed, Curr Opin Anaesthesiol) - "Hemostatic disturbances during ECMO reflect a complex interplay between patient severity, circuit-related shear stress, and systemic anticoagulation. Understanding these mechanisms is key to preventing both bleeding and thrombosis. Standardization of monitoring and the development of personalized, physiology-based anticoagulation protocols, supported by emerging technologies and more biocompatible circuits, represent the next step toward improving outcomes in ECMO-supported patients."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

Platelet dynamics and clinical outcomes in patients with heparin-induced thrombocytopenia – single center experience (ASH 2025) - "Several agents, such as bivalirudin, argatroban, danaparoid, and fondaparinux, have been used for the treatment of HIT. The dynamics of platelet counts after diagnosis may be an important tool for assessing treatment efficacy. Despite treatment, the mortality rate in critically ill patients with HIT remains high."

Clinical • Clinical data • Cardiovascular • Hematological Disorders • Thrombocytopenia

Heparin-induced thrombocytopenia after percutaneous coronary intervention complicated by hemothorax and pulmonary thromboembolism: The scylla and charybdis of hematology (ASH 2025) - "Those with a confirmed diagnosis need to be started on therapeutic-dose anticoagulation with argatroban, danaparoid, bivalirudin, or fondaparinux. Our case highlights a unique case of HIT with both thrombosis and life-threatening bleeding post-PCI that precluded the use of both anticoagulation and antiplatelets, underscoring the complexity of care, need for a multidisciplinary approach, and individualization of treatment in such cases."

Cardiovascular • Cerebral Hemorrhage • Chronic Kidney Disease • Diabetes • Endocrine Disorders • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Thrombocytopenia

Medical and perioperative management of acute and subacute heparin-induced thrombocytopenia in adults requiring urgent cardiopulmonary bypass surgery. (ASH 2025) - "After diagnosis of HIT, most were started on the alternative anticoagulants argatroban or bivalirudin(bival) in 0-1 days...These cases(each n=1) were not grouped: IO heparin+tirofiban with pre-op PLEX+IVIG, IO heparin alone, IO heparinwith pre-op plus IO PLEX, and 1 who died before planned surgery...IO bival appears to increase risk of IO and post-op bleeding but conclusions are limited bysample size. Larger, comparative studies are needed to determine and characterize the optimalmanagement approach for this unique clinical scenario."

Clinical • Surgery • Acute Kidney Injury • Cardiovascular • Hematological Disorders • Infectious Disease • Nephrology • Renal Disease • Thrombocytopenia • Thrombosis

Cost-effectiveness of heparin-induced thrombocytopenia (HIT) diagnostic strategies: Rapid PF4/heparin versus ELISA-based antibody testing strategies in the care of hospitalized people with suspected HIT (ASH 2025) - "All patients in an ELISA-based strategy were switched to non-heparinanticoagulation whereas patients in a rapid-based strategy were switched only if the assay was positive.Both bivalirudin (base-case) and argatroban (scenario analysis) were examined. This is achieved by reducing thecosts associated with unnecessary non-heparin anticoagulation and major bleeds in patients who testnegative for HIT. In addition, our model allows individual stakeholders to assess cost-effectiveness basedon their own quoted coagulation analyzer price and expected annual volume of HIT diagnostic tests."

Clinical • Cost effectiveness • HEOR • Cardiovascular • Hematological Disorders • Thrombocytopenia • Thrombosis

HIT or miss?: Long-term outcomes of direct thrombin inhibitors vs fondaparinux use in heparin-induced thrombocytopenia (ASH 2025) - "Cohort A had 1489patients diagnosed with HIT and treated with fondaparinux while Cohort B had 1489 patients diagnosedwith HIT and treated with direct thrombin inhibitors (argatroban, bivalirudin, lepirudin or desirudin). Our study provides evidence that fondaparinux significantly reduces the risk of mortality and adverseevents including myocardial infarction, skin necrosis, arterial embolism/thrombosis and moderate tosevere thrombocytopenia at one year compared to DTIs for the management of HIT. In addition to theseclinical benefits, fondaparinux offers cost advantages and ease of use, with its subcutaneousadministration, predictable pharmacokinetics, and minimal need for laboratory monitoring making itparticularly useful in outpatient and resource-limited settings. However, fondaparinux carries anincreased risk of major bleeding, particularly intracranial hemorrhage, due to the lack of a reversal agent.It is also contraindicated in patients with renal impairment and..."

Acute Kidney Injury • Cerebral Hemorrhage • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Diabetes • Diabetic Nephropathy • Fibrosis • Gastroenterology • Genetic Disorders • Heart Failure • Hematological Disorders • Hepatology • Immunology • Ischemic stroke • Liver Cirrhosis • Metabolic Disorders • Myocardial Infarction • Nephrology • Obesity • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Thrombocytopenia

Cost effectiveness of in-house HIT screening testing in community based hospital (ASH 2025) - "Empiric anticoagulation was initiated in 147 (28.8%) patients, withargatroban in 85 (57.8%), fondaparinux in 50 (34.0%), and 12 (8.2%) receiving other anticoagulants(apixaban, rivaroxaban, or bivalirudin)...Only 48 (18.6%) patients received empiricanticoagulation, with argatroban used in 25 (52.1%), fondaparinux in 17 (35.4%), and otheranticoagulants (apixaban and bivalirudin) in 6 (12.5%)...Theimplementation of in-house HIT screening tests resulted in an annual cost saving of $17,181 inanticoagulation alone. ConclusionImplementation of the HIT testing algorithm using an in-house screening test with a reflex outsourcedconfirmatory test resulted in decreased turnaround time, reduction of empiric anticoagulation utilization,and potential cost savings for hospitalized patients with suspected HIT."

Clinical • Cost effectiveness • HEOR • Hematological Disorders • Thrombocytopenia

Current practices of anticoagulant utilization in pediatric patients with acute myeloid leukemia (AML) (ASH 2025) - "Evaluated anticoagulants included lowmolecular weight heparins, the oral thrombin inhibitors, oral factor Xa inhibitors, and the vitamin Kantagonist warfarin. Continuous anticoagulants, such as unfractionated heparin and bivalirudin, wereexcluded due to their role in complex critical care outside of the management of thrombosis...Enoxaparin was the most frequentlyutilized anticoagulant (150/171; 87.7%) followed by rivaroxaban (22 patients; 12.9%)...Anticoagulation practices for pediatric patients with AML vary widely by institution. Bleeding prevalencewas not found to be greater among patients receiving presumed prophylaxis compared to patients whoreceived anticoagulation to treat TE, and those who did not receive anticoagulation. This suggests theremay be a role for safe utilization of prophylaxis in high-risk patients."

Clinical • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Pediatrics • Respiratory Diseases • Thrombocytopenia • Venous Thromboembolism

Management of heparin-induced thrombocytopenia in impella-supported cardiac surgery: A comprehensive four-patient case series with novel anticoagulation strategies (ASH 2025) - "Each patient received a distinct:ultra-low-dose argatroban purge, bivalirudin purge with systemic therapy, therapeutic plasma exchange(TPE) plus intravenous immunoglobulin (IVIg) enabling UFH re-exposure, and heparin-free bicarbonatepurge. Median age was 58 years (range 47-71). Individualized, guideline-concordant anticoagulation strategies—including novel purgesolutions and immunomodulatory approaches—enable safe Impella support in HIT patients undergoingcomplex cardiac surgery."

Clinical • Surgery • Cardiovascular • Hematological Disorders • Thrombocytopenia • Thrombosis

Increased Incidence of Thrombosis in Patients at Risk of Heparin-Induced Thrombocytopenia Receiving Epoprostenol for Cardiac Surgery. (PubMed, J Cardiothorac Vasc Anesth) - "The rate of thrombosis in our review was considerably higher than the published data on the use of prostacyclin analogues with heparin in patients with HIT, suggesting that this strategy may not be as effective for preventing thrombosis as previously thought. Until larger studies can be conducted, it may be in the best interest of patients with HIT for surgical teams to utilize alternative agents, such as bivalirudin, for anticoagulation in cardiac surgery."

Journal • Cardiovascular • Hematological Disorders • Thrombocytopenia • Thrombosis

A Comparative Analysis of Bivalirudin and Heparin for Extracorporeal Membrane Oxygenation in a Pediatric Cardiothoracic Intensive Care Unit. (PubMed, ASAIO J) - "Extracorporeal membrane oxygenation patients on bivalirudin had greater odds of survival to decannulation (odds ratio [OR]: 3.7 [1.4, 11.5], p = 0.01) and discharge (OR: 3.1 [1.4, 7.2], p < 0.01). The use of bivalirudin for ECMO in the pediatric cardiothoracic ICU population appears safe with fewer major bleeding and thrombotic complications and may be associated with improved survival compared to heparin."

Journal • Critical care • Pediatrics • Transplantation

A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction (clinicaltrials.gov) - P=N/A | N=206 | Active, not recruiting | Sponsor: NYU Langone Health | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Coronary Artery Disease • Heart Failure • Myocardial Ischemia

Alternative Anticoagulation for Patients with Heparin-Induced Thrombocytopenia on ECMO: A Narrative Review. (PubMed, Biomedicines) - "Most available data, primarily from retrospective studies, describe the use of argatroban in ECMO patients with HIT. Bivalirudin has also been used as an alternative anticoagulant in this population, with no significant increase in bleeding or thrombotic complications...Fondaparinux has shown effectiveness in the HIT setting and appears to have a low risk of complications. Factor XIIa inhibitors represent a novel class of anticoagulants currently under investigation, evaluated only in animal models. Growing clinical experience with alternative anticoagulants, particularly direct thrombin inhibitors, suggests that their use will likely become a primary focus in ECMO anticoagulation management in the coming years."

Journal • Review • Cardiovascular • Critical care • Hematological Disorders • Thrombocytopenia • Thrombosis

Heavy Menstrual Bleeding in Adolescents on Direct Oral Anticoagulants (ASH 2023) - "Background Direct oral anticoagulants (DOACs) – Dabigatran, Rivaroxaban, and Apixaban - are increasingly being used in the pediatric and adolescent population...The control group was defined as patients on anticoagulants other than DOACs, such as LMWH, unfractionated heparin, coumadin, and bivalirudin...Patients with known risk factors of HMB had an increased rate of HMB with all anticoagulants. Prospective studies are needed to further elucidate the impact of DOACs and other anticoagulants on HMB in adolescents."

Cardiovascular • Gynecology • Pediatrics • Venous Thromboembolism • Women's Health

Incidence and Timing of Thromboembolism in Pediatric Patients with Congenital Heart Disease Undergoing Cardiac Surgery: A Single Center Retrospective Study (ASH 2023) - "Treatment agents in the subacute period included: no agent (10, 27.8%), enoxaparin (17, 47.2%), bivalirudin (2, 5.6%), unfractionated heparin (1, 2.8%), rivaroxaban (2, 5.6%), and new/increased antiplatelet therapy (4, 11.1%%). Awareness of TE prior to cardiac surgery may be beneficial for optimizing post-operative prevention strategies to minimize the recurrence of TE. Future multicenter prospective studies are needed to validate these findings and evaluate risks factors for TE in pediatric patients with CHD both before and after cardiac surgery."

Retrospective data • Surgery • Cardiovascular • Heart Failure • Inflammation • Pediatrics

Increased Neonatal Mortality and Increasing Rate of Cerebral Venous Sinus Thrombosis in Hospitalized Children: A Pediatric Health Information System Database Study (ASH 2023) - "Enoxaparin and unfractionated heparin (UFH) remained the primary treatments for CVST, with UFH utilized more often in neonates (71.6% vs. 59.2%; p<0.001)...The use of bivalirudin, and DOACs was present in the late vs. none in the early era (p<0.001 except Dabigatran)... Pediatric CVST is a serious disorder, with an overall mortality rate of 4.2% in our study. Neonates had distinct clinical features, associated diagnoses, and complications compared to older children. Predominantly UFH and rarely DOACs were administered in neonates."

Clinical • Cardiovascular • CNS Disorders • Heart Failure • Hematological Disorders • Hypertension • Infectious Disease • Otorhinolaryngology • Pediatrics • Respiratory Diseases • Septic Shock • Sinusitis • Thrombosis • Ventriculomegaly

Renal Thrombotic Microangiopathy as the Primary Manifestation of Heparin-Induced Thrombocytopenia: A Diagnostic and Therapeutic Challenge (KIDNEY WEEK 2025) - "Anticoagulation was switched to bivalirudin...Argatroban failure suggests HIT-TMA may need more aggressive anticoagulation. This case redefines HIT’s renal spectrum & biopsy’s diagnostic role. Glomerulus with features of acute TMA including endothelial swelling, RBC fragmentation, karyorrhexis"

Atypical Hemolytic Uremic Syndrome • Cardiovascular • Complement-mediated Rare Disorders • Hematological Disorders • Nephrology • Thrombocytopenia • Thrombosis • Vasculitis • HP

Management of Refractory Heparin-Induced Thrombocytopenia with Ivig, Plasma Exchange, and Rituximab: A Case Report (ASH 2024) - "Argatroban was started, and thrombectomy of her lower extremity was performed...IVIg was initiated for 3 days, and AC was transitioned to bivalirudin...Additional research into the pathophysiology and management of this entity is needed.Conclusion : There are no current guidelines for treating severe refractory HIT. Further investigation is necessary to assess the role of autoimmunity and immunosuppression in managing this life-threatening condition."

Case report • Clinical • Cardiovascular • Hematological Disorders • Thrombocytopenia

Real World Data on the Utility of P-Selectin Expression Assay; Correlation of Test Results and Disease Expression (ASH 2024) - "15/24 (62.5%) were treated as HIT based on clinical suspicion, 4Ts scores, and OD values despite negative PEA results, most commonly with Bivalirudin followed by Warfarin or direct oral anticoagulants (DOACs). These results emphasize the importance of continuously reassessing binary tests. We propose reviewing larger data sets to assess if a separate intermediate PEA risk group might need to be defined while incorporating clinical parameters to finalize the diagnosis and help guide appropriate management."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Thrombocytopenia • SELP

Bivalirudin Monitoring By Dilute Thrombin Time Is Cost-Efficient in Pediatric ECMO Patients (ASH 2024) - "Previous studies have reported decreased need for blood product transfusions and circuit changes with bivalirudin, with favorable or equivalent total costs in MCS patients. This work demonstrates that dTT monitoring of bivalirudin in pediatric patients during the first 5 days of ECMO is cost-efficient and potentially reduces total laboratory test/blood volume sampling."

Clinical • Cardiovascular • Hematological Disorders • Pediatrics • Thrombosis

Primary Anticoagulation With Bivalirudin Versus Heparin for Microaxial Flow Pump Supported Patients. (PubMed, ASAIO J) - "Patients in the DTI group had fewer aPTT variations of greater than 20% and aPTT values exceeding 80 seconds (p < 0.001). In the largest available study performed in mAFP patients, DTI for anticoagulation was comparable to heparin with a possibly more stable effect on aPTT."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

Comparative Outcomes of Bivalirudin Versus Heparin in Cardiogenic Shock Patients Supported with Impella Device: A Propensity-Matched Multicenters Analysis (AHA 2025) - "Despite these differences, survival was similar between groups. These findings highlight the need for randomized trials to clarify optimal anticoagulant strategies."

Clinical • Cardiovascular • Myocardial Infarction

Effects of bivalirudin on instant blood-mediated inflammatory reaction after intraportal islet transplantation. (PubMed, Cell Transplant) - "Collectively, BT and HT alleviate coagulation activation and inflammatory infiltration characteristic of IBMIR, thereby improving post-transplant islet survival. BT demonstrated greater anti-thrombotic and anti-inflammatory activity than HT in this setting, supporting bivalirudin as a promising adjunct anticoagulant strategy for intraportal islet transplantation and potentially other cell-therapy applications."

Journal • Transplantation • TNFA

UPDATED META-ANALYSIS OF BIVALIRUDIN VS HEPARIN IN PEDIATRIC EXTRACORPOREAL MEMBRANE OXYGENATION (CHEST 2025) - "BIV appears to offer advantages over UFH in pediatric ECMO by significantly reducing red blood cell transfusion needs. While trends suggest lower platelet transfusions, ischemic stroke, and in-hospital mortality, these findings were not statistically significant. CLINICAL IMPLICATIONS: The findings from this meta-analysis suggest that Bivalirudin could be a promising alternative Unfractionated Heparin in pediatric ECMO, particularly due to its potential to reduce the need for packed red blood cell and platelets transfusions."

Retrospective data • Cardiovascular • Hematological Disorders • Infectious Disease • Ischemic stroke • Pediatrics

STUCK BETWEEN A CLOT AND A HARD PUMP: THE CLINICAL CONUNDRUM OF VA-ECMO AND TTP (CHEST 2025) - "The patient was started on daily plasma exchange therapy and 1 mg/kg/day of prednisone. She was kept on bivalirudin in the interim... VA-ECMO provides crucial hemodynamic support and management of cardiogenic shock. The patient case highlights the varying etiologies for thrombocytopenia in this special patient population. Early recognition of clinical features, such as schistocytosis, and the use of diagnostic scoring systems like PLASMIC are vital for prompt diagnosis and management to optimize outcomes."

Clinical • Acute Kidney Injury • Anemia • Cardiomyopathy • Cardiovascular • Hematological Disorders • Nephrology • Renal Disease • Thrombocytopenia • Thrombocytopenic Purpura