Functional Fluidics recently participated in a pivotal study, the Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) which demonstrated that their biomarkers provide biologic evidence to validate self-reported pain in individuals with sickle cell disease.
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS)
Sickle cell disease (SCD) is characterized by frequent and unpredictable vaso-occlusive episodes (VOEs) that produce severe pain, organ damage, and early death. Lack of reliable biomarkers to objectively define VOEs, hinders the development of clinically useful interventions to improve the care for these patients. Functional Fluidics recently participated in a ground-breaking study to help to solve this challenge.
The Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) is a non-interventional, longitudinal study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization.
ELIPSIS Study Design
During the 6 months of evaluation, longitudinal measures of pain, fatigue, function, activity (by actigraphy), clinical laboratory and biomarker samples from SCD patients (+/- hydroxyurea therapy) in steady state to VOC were studied.
- The study enrolled 37 participants with SCD; 35 completed the study.
- Participants wore an actigraph device, tracking sleep and activity.
- SCD patients used an electronic patient-reported outcome (ePRO) tool collecting pain, medication, fatigue, and daily function.
- Patients self-reported when they experienced VOC pain (VOC day).
- Biomarkers were collected every 3 weeks (non-VOC) and within 24 hours of self-reported VOCs triggered at-home or in-hospital.
Functional Fluidics Biomarker Key Findings
Functional Fluidics Red Blood Cell biomarkers measure the degree to which red blood cell adhesion and fragility change in pain. This type of gradation of VOC (vaso-occlusive crisis) allows us to truly understand the impact of this disease on patients who are in pain. Ultimately, these red blood cell biomarkers can serve as surrogate endpoints that give providers more tools to keep people healthy as opposed to intervening during a crises.
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Differentiate Healthy vs Sick
Differentiate the healthy state from the acute crises state in individuals with sickle cell disease.
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Stratify for Acute Pain Risk
Stratify patients at their steady state based on their risk for developing acute pain crises.
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Define Mechanism of Acute Pain Crises
Define mechanism of adhesion-associated acute pain crises.
Functional Fluidics Biomarkers
ELIPSIS indicates that Functional Fluidics biomarker can help predict Sickle Cell Disease vaso-occlusive crises (VOCs) and monitor drug therapy progress.
Our biomarkers assess the health of red blood cells by replicating the environment that they experience in our bodies and providing that information to doctors and scientists allowing them to make better decisions about drug development and patient care.
LEARN MORE
RETHINKING SICKLE CELL DISEASE PATIENT CARE WEBINAR SERIES Stay Connected for Upcoming Sessions
Recorded Webinar: Leveraging Red Blood Cell Health Biomarkers to Maintain Health in Individuals with Sickle Cell Disease
Join an expert panel of clinicians and scientists as they discuss insights from the Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS), a pivotal study evaluating the relationship of blood-based biomarkers and pain from the patient’s perspective:
- How red blood cell health biomarkers can be used to differentiate self-reported healthy state from acute crises state
- How red blood cell health biomarkers can help stratify patients based on their risk of developing self-reported acute pain crises
- How red blood cell health biomarkers can be diagnostic biomarkers of adhesion-associated acute pain crises
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by Electronic Patient-Reported Outcomes, Actigraphy, and Biomarkers
Functional Fluidics Biomarker Assay Featured in ELIPSIS article in American Society of Hematology (ASH) Blood Magazine
Key Points
- Feasibility of monitored out-of-hospital pain and patient-reported VOC days as endpoints for clinical trials in SCD is demonstrated.
- ePROs, actigraphy, and laboratory biomarkers enable improved identification and assessment of in-hospital and out-of-hospital VOCs.
Publications & Abstracts
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by Electronic Patient-Reported Outcomes, Actigraphy, and Biomarkers
This non interventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization.
Evaluation of Coagulation and Inflammatory Markers in Pediatric Patients on Extracorporeal Membrane Oxygenation (ECMO)
The aims of this study were to evaluate if novel laboratory tests could better predict patients at risk for bleeding and/or thrombosis compared to routine laboratory tests
Longitudinal Evaluation of a Standardized P-Selectin Flow Adhesion Bioassay: Potential Role for the Assessment and Prediction of Vaso-Occlusive Episodes in Sickle Cell Disease
We developed a standardized, flow-based adhesion assay to measure p-selectin mediated adhesion in SCD. Whole blood (Wb) and isolated WBC samples were perfused (1.0 dynes/cm2, 1.67Hz) through micro-fluidic channels
Sevuparin blocks sickle blood cell adhesion and sickleleucocyte rolling on immobilized L-selectin in a dose dependent manner
Adhesion of sickle red blood cells (SSRBC) to the vascular endothelium may initiate and propagate vascular obstruction in sickle cell disease (SCD)
Impact of Environment on Red Blood Cell ability to Withstand Mechanical Stress.
Susceptibility of red blood cells (RBC) to hemolysis under mechanical stress is represented by RBC mechanical fragility (MF), with different types or intensities of stress potentially emphasizing different perturbations of RBC membranes
An Approach to Measuring RBC Haemolysis and Profiling RBC Mechanical Fragility
Red blood cells (RBC) can be damaged by medical products, from storage or from disease. Haemolysis (cell rupture and haemoglobin release) is often a key indicator, with mechanical fragility (MF) offering the potential to assess sub-haemolytic damage as well
Low Molecular Weight Heparin Inhibits Sickle Erythrocyte Adhesion to VCAM-1 through VLA-4 Blockade in a Standardized Microfluidic Flow Adhesion Assay
The vaso-occlusive events in sickle cell disease (SCD) begin in early childhood, warranting the need for more preventative and therapeutic interventions for those affected
A Longitudinal Study to Identify and Assess Adhesion Indices during Vaso-Occlusive Crises in Adults and Adolescents with Sickle Cell Disease
Standardized adhesion indices may serve as useful biomarkers to asses the contribution of adhesin to an individual patient’s VOCs