November 6, 2008
Hemametrics Announces New Study Demonstrating That Crit-Line Use May Contribute to Reduction of Hemoglobin Variability in Hemodialysis Patients
Two presentations during the American Society of Nephrology's Renal Week demonstrated that frequently monitoring hemoglobin during hemodialysis will provide physicians with trending information that may reduce hemoglobin variability. The study demonstrated increased time-in-target range for hemoglobin in end-stage renal disease patients. The study suggests that increased frequency of hemoglobin monitoring may contribute to more accurate dosing for anti-anemia medication (e.g., erythropoietin stimulating agents, or ESAs) and lead to improved outcomes. The study used Hemametrics's Crit-Line III TQA hematocrit monitor.
"This study demonstrates that a simple monitor, that can non-invasively measure hemoglobin each dialysis treatment, can provide physicians with real-time trending information. An upward or downward trend in hemoglobin can allow the physician to modify the ESA dose and prevent the patient from going above or below the target range indicated in the FDA label for ESAs, which recommends the target range of 10-12 g/dl." says Michael J. Germain, MD, Professor of Medicine at Tufts University School of Medicine. "Using a monitor like Crit-Line that gives a real-time hemoglobin each treatment, as we did in these two studies, may allow doctors to use a more accurate algorithm to predict correct ESA dosing.""We were very pleased to be part of these studies, as they demonstrated the importance of hematocrit monitoring in the dialysis process and represent a new use for our Crit-Line system using exclusive Crit-Line software and a patented process," comments Patrick Moriarty, CEO of Hemametrics. "Currently, Crit-Line allows customized volume, oxygen and anemia management during hemodialysis, providing clinicians with evidence-based criteria to obtain the ideal dry weight of each patient, which will ultimately reduce congestive heart failure symptoms and thereby hospitalization and mortality. We believe that expanding these criteria in order to help physicians determine hemoglobin trends, which may impact ESA dosing - and indeed this may be useful when bundling of services are mandated by CMS - only underscores the fact that Crit-Line should be in every dialysis clinic and available for every dialysis patient."
About The Study
The study hypothesized that increased hemoglobin monitoring with fluid management and an investigational computer algorithm would reduce hemoglobin variability and increase the percentage of time patients were in target range. In this study, 44 dialysis patients in a single dialysis clinic were monitored using Crit-Line during their treatment regimen over the course of 15 months. The monitoring periods was phased over three periods. In Phase One, hemoglobin was recorded at each dialysis treatment but no changes were made in volume management. In the second phase, the dialysis center staff followed a strict protocol of fluid management based on the results of the Crit-Line readings. In the third phase, an investigational computer algorithm provided suggested EPO and iron doses based on a three-times-per-week hemoglobin value obtained from the Crit-Line device. Results of the study suggested that when these frequent hemoglobin values as determined by a fluid management system (Crit-Line) were used with a computer algorithm (AMIE Leeds England), intra-patient hemoglobin variability and the percentage of time in target were statistically significantly improved compared the baseline phases (patients served as their own controls).
In a second presentation, the authors demonstrate that a robust mathematical model may be developed from this study data. This model forms the basis for the investigational computer algorithm on which revised software for the Crit-Line hemoglobin management system was based.
The study was supported as an Investigator-sponsored study to Dr. Michael Germain from Amgen, Inc. Crit-Line monitors for the study were provided by HemaMetrics, Inc.
Crit-Line III-TQA is a fluid management and access monitoring tool used during hemodialysis that incorporates photo-optical technology to non-invasively measure absolute hematocrit, percent blood volume change, continuous oxygen saturation and access recirculation. Using red blood cells as the marker, Crit-Line determines the fluid volume change in the bloodstream during a dialysis treatment, essentially using light to determine the ratio between hematocrit and extra fluid in the bloodstream.
This measurement helps physicians better determine both the length of a dialysis treatment and how effective it was. Using Crit-Line, patients report decreased fear of having symptoms, quicker post-dialysis recovery time, fewer medications and improved quality of life.
Further, Crit-Line's improvement of dialysis treatment outcomes results in significantly increased gross revenues for facilities thru increased patient longevity, fewer cardiac related hospitalizations, and unpredicted missed treatments. In fact just two missed treatments per year per patient, pays for the device and disposables in three months or less. The Crit-Line and its associated products are FDA 510(k) cleared, carry the CE mark and are CLIA exempt.
Headquartered in Salt Lake City, Utah, HemaMetrics is a cutting-edge medical device company working from a base of strong existing patents in optical technology that provides solutions for non-invasive blood measurement. Its platform Crit-Line III TQA technology base enables non-invasive, optical measurement of absolute blood parameters, while the company continues research into further applications and new markets to improve outcomes for medical patients.