Related Experiment Video
Updated: Jan 1, 2026

In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
Monitoring bivalirudin therapy in children on extracorporeal circulatory support devices: Thromboelastometry versus
Jun Teruya1, Lisa Hensch2, Karen Bruzdoski2
1Department of Pathology & Immunology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, United States of America; Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, United States of America; Department of Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, United States of America.
Insights
Thromboelastometry (ROTEM) assays, specifically HEPTEM and INTEM, show promise in monitoring bivalirudin anticoagulation in pediatric extracorporeal life support (ECLS) patients. These methods correlate well with traditional tests and may offer a superior alternative for managing heparin-like effects.
Area of Science:
- Pediatric Critical Care Medicine
- Hematology
- Cardiovascular Surgery
Background:
- Bivalirudin is a key anticoagulant for pediatric extracorporeal life support (ECLS).
- Activated partial thromboplastin time (aPTT) is the standard monitoring test, but its utility with thromboelastometry (ROTEM) in ECLS is not well-established.
- ROTEM offers a comprehensive assessment of hemostasis.
Purpose of the Study:
- To evaluate the effectiveness of ROTEM assays in monitoring bivalirudin therapy in pediatric patients on ECMO or VAD.
- To compare ROTEM results with standard coagulation assays for bivalirudin monitoring.
Main Methods:
- Retrospective analysis of 106 blood samples from 18 pediatric patients on ECMO/VAD receiving bivalirudin.
- Comparison of ROTEM (EXTEM, INTEM, HEPTEM, FIBTEM) with routine tests (aPTT, HPTT, PT, fibrinogen, platelet count).
- Analysis of clotting time (CT) and maximum clot firmness (MCF) in ROTEM assays.
Main Results:
- Strong correlation observed between HPTT and HEPTEM CT; moderate correlation between aPTT and INTEM CT.
- Bivalirudin dose showed age-dependence, not correlation with specific tests.
- FIBTEM MCF correlated well with fibrinogen, but overestimated levels at high platelet counts.
- Heparin-like effect detected in 39% of samples.
Conclusions:
- INTEM and HEPTEM CT prolongation correlate with aPTT and HPTT, suggesting ROTEM as a viable alternative for bivalirudin monitoring.
- HPTT and HEPTEM CT are potentially preferable for ECLS due to better detection of heparin-like effects.
- ROTEM provides valuable insights into hemostasis during bivalirudin therapy in pediatric ECLS.
Introduction:
Bivalirudin is an alternative to heparin anticoagulation in infants and children in the setting of extracorporeal life support (ECLS). While activated partial thromboplastin time (aPTT) is widely accepted as the standard test to monitor bivalirudin therapy, the usefulness of thromboelastometry (ROTEM) to monitor bivalirudin infusion in the setting of ECLS is unknown.
Objective:
We aimed to assess the utility of ROTEM in monitoring hemostasis and bivalirudin effect in children on either extracorporeal membrane oxygenation (ECMO) or ventricular assist devices (VAD) compared to standard plasma based coagulation assays.
Methods:
A retrospective study of children undergoing bivalirudin infusion for ECMO/VAD support from a tertiary care pediatric hospital (January 2017-June 2018) was performed. ROTEM assays for extrinsic (EXTEM) and intrinsic (INTEM) coagulation pathways, INTEM with heparinase (HEPTEM), fibrin formation (FIBTEM) with measurement of the clotting time (CT) and maximum clot firmness (MCF) were compared to routine hemostasis testing including: aPTT, aPTT Hepzyme (HPTT), prothrombin time (PT), fibrinogen and platelet count.
Results:
One hundred and six blood samples from 18 children were tested. There was a strong positive correlation between HPTT and HEPTEM CT, and moderate correlation between aPTT and INTEM CT. The bivalirudin dose did not correlate with any test, but displayed strong age-dependence, with infants requiring higher doses of bivalirudin to maintain therapeutic targets. Excellent correlation was found between FIBTEM MCF values and fibrinogen, but FIBTEM overestimated fibrinogen level when platelet count was >300 × 109/L. Heparin-like effect was identified in 39% of specimens, and an improved correlation between aPTT and INTEM CT was observed in specimens without heparinoids.
Conclusions:
In the setting of bivalirudin therapy, prolongation of CT on INTEM and HEPTEM showed moderate to strong correlation with aPTT and HPTT, and therefore, may provide a good alternative to these assays. In addition, HPTT and HEPTEM CT might be preferable for monitoring bivalirudin in the setting of ECLS due to frequent detection of heparin-like effect.
Related Concept Videos
Venous Thrombosis III: Interprofessional Care
Anticoagulant Drugs: Low-Molecular-Weight Heparins
Extracorporeal Removal of Drugs: Continuous Renal Replacement Therapy
Pulse rhythm
Conversely, an irregular pulse pattern is termed dysrhythmia, stemming from disruptions in cardiac...
Venous Thrombosis II: Clinical Manifestations and Diagnostic Studies
Venous Thrombosis IV: Nursing Management

