Clinical Trials of Groundbreaking Point-of-Care Device to Measure Clotting to Begin at University Hospitals in 2020

A World of Information in a Single Drop of Blood

Innovations in Pediatrics | Fall 2019

Clinical trials of a locally developed, point-of-care monitor for testing the clotting ability of blood will soon get under way at University Hospitals in Cleveland, with implications for patients with bleeding and clotting disorders, but also those taking next-generation anticoagulants or undergoing surgery.

The device, dubbed ClotChip, was developed by engineers from the Electrical, Computer and Systems Engineering Department at Case Western Reserve University.

 Sanjay P. Ahuja, MD

Sanjay P. Ahuja, MD, a pediatric hematologist & Dominic Piunno Endowed Chair in Hemophilia & Bleeding Disorders at UH Rainbow Babies & Children’s Hospital; and Associate Professor of Pediatrics, Case Western Reserve University School of Medicine is leading the clinical trials here and credits the ingenuity of the team at the university.

“ClotChip uses principles of electricity to measure coagulation in blood,” he says. “This is a novel concept because current assays use biochemical methods of detection of coagulation. With ClotChip, a complex biochemical reaction, such as coagulation, can be boiled down to a simple technique of measurement at the point of care, at the bedside.”

One clear advantage of ClotChip over current coagulation monitoring methods is its relatively tiny blood sample requirement.

“One drop is enough to measure, just like a glucometer in patients with diabetes,” Dr. Ahuja says. “Our current methodologies use three to five milliliters, so up to a teaspoon of blood.  In pediatrics especially, any test method that uses a minimal amount of blood is extremely valuable.”

In preliminary testing, Dr. Ahuja and his colleagues have evaluated ClotChip in children with severe hemophilia A, looking to see if it was sensitive enough to pick up the clotting changes resulting from coagulation factor replacement therapy.

Results show that the device performed well.

“We showed that not only is it able to correctly detect the abnormalities that these patients have with coagulation, but also its correction,” he says. “They don’t have Factor VIII, so their blood does not clot well. We were able to pick this up. But we also showed that once we gave the appropriate therapy and treatment, it corrected the abnormality in coagulation and normalized the test. We showed that ClotChip is sensitive to coagulation-factor therapy and can be used to monitor coagulation-factor therapy.”

Results from ClotChip are typically ready in about 15 minutes and can be sent to a patient’s physician using Wi-fi or Bluetooth. This speed, Dr. Ahuja says, has the potential to redefine what can often be an onerous and uncertain process of testing and re-testing for patients with bleeding & clotting disorders.

“Even after treatment, patients don’t have adequate Factor VIII levels all the time,” he says. “The protein that is infused in the blood has a half-life. It keeps degrading until you give the next dose. It’s sort of unknown at what point the next dose is required or whether the patient can safely perform certain activities. To know that, you have to measure the level of Factor VIII, which is a laborious task requiring a trip to the hospital. We’re trying to avoid that with a simple test like this.” 

In anticipation of FDA approval, Dr. Ahuja and his colleagues are planning studies with larger groups of patients.

“We want to show proof of principle that the device is useful in real-life scenarios at home, when used by the patients, with the information transmitted to physicians and patients to act on,” he says.

One trial will involve hemophilia patients. Another will test whether ClotChip can replace some pre-operative blood testing. 

“We want to see whether we can use this test to replace some of the workup that we do with patients pre-operatively,” Dr. Ahuja says. “Those tests are called PT & PTT. They are sent to us in hematology to sort out why they’re abnormal, and they require a great number of tests and collectively millions of dollars of workup. A lot of times we don’t find anything because the PT & PTT test are very insensitive tests. We are trying to replace the PT & PTT with Clotchip to see whether it can pick up the abnormalities more effectively.”

Other investigators at UH will also evaluate ClotChip in patients taking newer anticoagulants, such as to treat deep vein thrombosis or to prevent thrombosis and stroke.

As these trials get under way in 2020, Dr. Ahuja is optimistic about the ultimate results.

“We are very hopeful and excited that ClotChip will work well in all these scenarios,” he says. “We want to collect useful data for the FDA so that is can be approved for use as a point-of-care device for patients. If you can get complex information with a single drop of blood, that’s a very valuable feature in any test.”

For more information about the ClotChip clinical trials at UH, please contact the Division of Pediatric Hematology & Oncology at 216-553-1947 or email Peds.Innovations@UHhospitals.org.