Related Experiment Video
Updated: Aug 23, 2025
Author Spotlight: Deciphering Coagulation Disorders in Traumatic Brain Injury Patients
Published on: August 4, 2023
Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric
Galit H Frydman1, Barry M Berger1, Vadim Kostousov2,3
1Coagulo Medical Technologies, Inc., Auburndale, MA.
Insights
A new rapid coagulation test accurately detects anticoagulation resistance in pediatric patients treated with bivalirudin or unfractionated heparin (UFH). This point-of-care test can identify patients at risk for clotting complications, improving treatment safety.
Area of Science:
- Pediatric Critical Care Medicine
- Hematology
- Clinical Pathology
Background:
- Bivalirudin and unfractionated heparin (UFH) are common anticoagulants in pediatric ICUs.
- A point-of-care test for anticoagulation resistance is lacking.
- Accurate monitoring is crucial for preventing thrombotic events.
Purpose of the Study:
- To evaluate a rapid (<10 min), low-volume (<50 uL) coagulation test.
- To detect and quantify anticoagulation effects of bivalirudin and UFH.
- To assess its utility in pediatric critical care patients.
Main Methods:
- Retrospective analysis of 41 frozen plasma samples from pediatric patients.
- Samples included patients on bivalirudin or UFH.
- Utilized a novel Clotting Time Score (CTS) with a clot time endpoint.
Main Results:
- The CTS demonstrated 100% sensitivity and 82% specificity in detecting pathologic clotting events.
- Conventional tests (PT, aPTT) showed significantly lower sensitivity and specificity.
- CTS identified subtherapeutic UFH anticoagulation in resistant patients.
Conclusions:
- The Clotting Time Score (CTS) is a valuable indicator of coagulation status in pediatric patients on bivalirudin or UFH.
- CTS can identify inadequate anticoagulation or resistance, potentially preventing clot formation.
- Rapid CTS testing may reduce anticoagulation-related complications by identifying high-risk patients.
Abstract:
Bivalirudin, an IV direct thrombin inhibitor, and unfractionated heparin (UFH) are frequently used anticoagulants in the pediatric critical care setting. An accurate, specific, point-of-care test to quantify and detect anticoagulation resistance is not currently available. This study evaluates the ability of a rapid (< 10 min), micro-volume (< 50 uL) coagulation test to detect and quantify the anticoagulation effect of bivalirudin and UFH using a functional, clot time endpoint in pediatric critical care patients.
Design:
Single-site retrospective laboratory sample analysis and chart review.
Setting:
A 105-bed pediatric and cardiac ICUs delivering extracorporeal membrane oxygenation.
Subjects:
Forty-one citrated, frozen, biobanked plasma specimens comprising 21 with bivalirudin and 20 with UFH from 15 anticoagulated pediatric patients were analyzed. Thirteen patients were on extracorporeal membrane oxygenation, one had a submassive pulmonary embolism, and one was on a left ventricular assist device.
Interventions:
None.
Measurement And Main Results:
A Clotting Time Score (CTS) was derived on each sample. The CTS detected patients that had developed a pathologic clotting event with 100% sensitivity and 82% specificity compared with prothrombin time with 25% sensitivity/76% specificity and activated partial thromboplastin time with 0% sensitivity/0% specificity. Additionally, the CTS detected subtherapeutic anticoagulation in response to UFH in patients that were clinically determined to be UFH resistant requiring alternative anticoagulation with bivalirudin.
Conclusions:
The CTS appears to be a clinically valuable indicator of coagulation status in patients treated with either UFH or bivalirudin. Results outside of the therapeutic range due to inadequate dosing or anticoagulation resistance appeared to be associated with clot formation. CTS testing may reduce the risk of anticoagulation-related complications via the rapid identification of patients at high risk for pathologic thrombotic events.
Related Concept Videos
01:09Coagulation
During the coagulation phase, clotting factors, or procoagulants, play a vital role in initiating and progressing the coagulation cascade. This cascade is a series of reactions...
01:17Assessment of Diffusion and Perfusion
The Role of Diffusion in Respiration
Diffusion is the process by which molecules move from an area of higher concentration to an area of lower concentration. In the respiratory system, this...
01:30Anticoagulant Drugs: Low-Molecular-Weight Heparins
01:18Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...