Authors: Sara D. Khangura, Sarah C. McGill
Horizon Scan reports provide brief summaries of information regarding new and emerging health technologies; Health Technology Update reports typically focus on a single device or intervention. This Horizon Scan summarizes the available information regarding an emerging technology, ClotChip, for the identification of blood clotting defects.
ClotChip is intended for use at the point of care and uses novel, low-cost technology to perform a rapid assessment of the blood's clotting ability.
Early evidence has demonstrated the feasibility and utility of ClotChip, which could benefit patients with a variety of bleeding disorders and could potentially save time for health care professionals.
Rapid and accessible assessment of a patient’s clotting ability can be critical to ensuring that effective and life-saving treatment is available — particularly for patients living with a bleeding disorder, as well as those who have experienced trauma.1 Among the many point-of-care (PoC) health technologies that are becoming available in a variety of settings, ClotChip is a portable device designed to rapidly assess the blood’s ability to clot.2
ClotChip is a PoC device that measures the clotting characteristics of a patient’s blood — often at the bedside — and can quickly identify patients who are at risk of either excessive bleeding or clotting, which can hasten life-saving treatment.1 The ClotChip device requires a small amount of whole blood,3 which can be collected quickly and with the ease of a finger stick (which is similar to the method used for collecting blood with a glucometer).4
ClotChip uses dielectric spectroscopy (DS) to analyze the clotting characteristics of the blood.5 DS is an analytical method that is used in a variety of contexts, and relies on electrical frequencies to identify the composition, structure, and behaviour of nanomaterials.6 When assessing the clotting properties of blood, DS is more specifically known as dielectric coagulometry, and is unique in its ability to characterize both the clotting time and platelet function of the blood.5 This measurement of both thrombin formation and platelet activation in a portable, PoC-enabled device is a feature of the ClotChip technology.3 The developers of ClotChip also highlight that the device is designed to assess the clotting properties of the blood as opposed to identifying the cause of a clotting defect, and that no reagents are required to operate the technology, setting it apart from some other coagulation sensors.3,4,7
Recent estimates indicate that there are approximately 300,000 people in Canada with a bleeding disorder (which can cause excessive bleeding).8 In addition, incidents of trauma and deaths from clotting defects number in the thousands each year in Canada,9,10 representing a large number of people who might benefit from more accessible and/or timely testing for blood clotting.
The portability of ClotChip and its availability at the PoC reduces the time associated with producing a test result by eliminating the need to send samples to a laboratory and ensuring that health care decisions can be made quickly.11,12 In addition to the reduced turnaround time for a test result, the very small amount of blood required from a patient is also suggested to be a beneficial feature of the device — particularly in emergency and neonatal care settings.13 Furthermore, the technology is described as requiring no special expertise or training to operate the device, making it usable by patients, caregivers, and clinicians alike.7
The benefits of ClotChip for assessing and/or monitoring the blood’s ability to clot may extend to patients in acute and/or trauma care settings,5,14 and cardiac surgical settings,15 as well as those with established clotting disorders.12,13 In addition, patients who are receiving anticoagulant therapy — such as direct oral anticoagulants (DOACs) — may also benefit from the availability of a PoC device such as ClotChip (i.e., in acute care and emergency surgery settings), as a rapid and accurate assessment of the effects of DOAC therapy on the blood’s ability to clot can support safe and effective treatment decisions.16
Health Canada currently lists no information regarding the availability or use of ClotChip in a Canadian context (including any trials or studies).17
The technology was designated by the FDA in the US as a breakthrough device in early 2020,1 and remains under investigation in clinical trials while awaiting FDA clearance.7 The commercial launch of ClotChip has been projected for late 2022.7
While no detailed cost information was identified for the ClotChip device, it has been described as low-cost in several published sources.3,5,18 Two of these sources indicate that the disposable chip used in the technology comes at a material cost of less than $1 per unit (though the currency used in this description is not specified).3,18
In addition to the cost of the device, as well as its use and maintenance over time, health care organizations and facilities that consider investing in a device like ClotChip should weigh its potential impact on current systems in place for coagulation testing, including care protocols, implications for health care workers (e.g., training), quality control, robust documentation, and data security.11 While no information specific to the cost of implementing the ClotChip was identified, it is described as easy to use, requiring no special training. This feature of the device could make implementation costs for health care facilities lower than would be necessary if in-depth staff training were necessary. In addition, resources and costs may be freed up for hospital-based and other laboratory services.
Current tests for monitoring blood clotting can be time-consuming or may not be readily available,19 with test turnaround times potentially taking hours,20 as compared to minutes for a PoC test. Conventional blood clotting tests are usually available in hospital only, and require the services of a central laboratory for processing, making rapid identification of clotting defects in non-hospital settings (e.g., community health care or field settings) difficult to access.5 The time delay associated with these conventional methods can be a barrier to identifying patients who may require immediate treatment for uncontrolled bleeding or excessive clotting.5
Evidence for ClotChip remains early in its development, mostly limited to pilot and feasibility studies with small sample sizes, ranging from 12 to 104 study participants.3,16,21-23 Earliest investigations of the technology relied on ex vivo assessments,3 with later studies using controlled methods and whole blood from study participants.5
Evidence to date has demonstrated the feasibility of ClotChip in the assessment of coagulation and clinical risk of bleeding, as well as monitoring of coagulation factor replacement therapy, for patients with hemophilia (both with and without inhibitors, as well as for those receiving emicizumab).18,19,21,22 Additional investigations have demonstrated the feasibility of ClotChip for identifying coagulation defects across a variety of clotting disorders, such as hemophilia and von Willebrand disease.3,23,24 Further investigation has focused on the utility of ClotChip for monitoring DOAC therapy, demonstrating its sensitivity to detect the anticoagulant effects of these drugs.16 While the accuracy of the ClotChip device has been compared against conventional technologies (including rotational thromboelastometry and thrombin generation assays) and produced comparable results,19,21,22 no evidence was found that compared ClotChip to another PoC device.
Since then, additional work has been initiated to assess the utility of ClotChip for patients with traumatic injuries14 as a presurgical screening tool, and for patients who may be at risk from COVID-19 clotting defects.7 The ability to rapidly detect clotting abnormalities has become increasingly important in recent years due to COVID-related complications that affect coagulation.2,25
While no data detailing the safety of ClotChip were identified, some sources describe relevant considerations for patient safety when using PoC coagulation tests.11,26 The small amount of blood required may benefit patient safety by reducing the risk of biohazardous contamination and/or the potential for mishandling of samples that may be associated with transportation from the point of collection to the site of analysis.11
One concern raised regarding PoC sensors is the potential for inconsistent or compromised documentation (i.e., whereas samples analyzed in a laboratory are generally entered systematically into institutional health care records, results from a PoC device may require manual data entry, which can introduce the risk of error).11 Of note, ClotChip devices can be Wi-Fi and Bluetooth enabled,1 which are useful features that may support integration within existing health care facility documentation systems, and could help minimize the potential for documentation errors or oversights.
Other PoC devices have also been developed to assess blood clotting using a variety of technologies, including electrical transduction,27 impedance platelet aggregometry,28 surface acoustic wave,29 and aptamer-based technologies.30
Some limitations of other PoC devices, as described by ClotChip developers, include variable accuracy in their assessments of coagulation and limitations in their characterization of platelet function.3,5 Some of these other PoC devices are specifically designed for assessing patients who are taking warfarin anticoagulant treatment; so, may not be useful to a broader population at risk for uncontrolled bleeding.5
The developers of ClotChip are also working toward expanded uses of the technology, including a similar device under development called TraumaChek.31,32 TraumaChek is described as a next-generation technology designed specifically for the assessment of coagulopathy in trauma settings.31,32 Proposed applications of this emerging technology have been described as including military field operations, as well as rural and remote health care settings, where the rapid detection of uncontrolled bleeding from trauma is essential for supporting the ability of health care providers to save lives.31-33 Of note, the developers of TraumaChek are partnering with other experts in the treatment of trauma-induced hemorrhaging to develop innovative approaches for rapidly detecting and treating uncontrolled bleeding at the PoC.31
Additional investigation has been proposed to examine the potential utility of ClotChip for the individualized care of people living with hemophilia A, such as the development of tailored prophylactic factor replacement therapies.22 In addition, ClotChip has been proposed and investigated as an intervention for measuring hypercoagulation in patients with conditions such as deep vein thrombosis, or infectious diseases that can cause dangerous clotting defects, such as sepsis and COVID-19.23,34 These and related developments in PoC technology have the potential to improve care and care pathways for patients with bleeding disorders, and could introduce efficiencies and resource savings for health care facilities and systems.
1.Cision PR Newswire. XaTek's ClotChip earns FDA's Breakthrough Device designation. 2020 Mar 3; https://www.prnewswire.com/news-releases/xateks-clotchip-earns-fdas-breakthrough-device-designation-301015380.html. Accessed 2022 Sep 21.
2.Cuffari B. The role of blood clot sensors in medical treatment and diagnostics. Manchester (UK): AzoSensors.com; 2022: https://www.azosensors.com/article.aspx?ArticleID=2526. Accessed 2022 Oct 27.
3.Maji D, De La Fuente M, Kucukal E, et al. Assessment of whole blood coagulation with a microfluidic dielectric sensor. J Thromb Haemost. 2018;16(10):2050-2056. PubMed
4.Mumal I. ClotChip, portable way of analyzing blood’s ability to clot, named Breakthrough Device. Hemophilia News Today. 2020;Mar 9. https://hemophilianewstoday.com/news/fda-names-xatek-clotchip-breakthrough-device/#:~:text=ClotChip%20measures%20bleeding%20risk%20by,in%20a%20person%20with%20diabetes. Accessed 2022 Oct 31.
5.Maji D, Suster MA, Kucukal E, et al. ClotChip: a microfluidic dielectric sensor for point-of-care assessment of hemostasis. IEEE trans. 2017;11(6):1459-1469.
6.Deshmukh K, Sankaran S, Ahamed B, et al. Chapter 10 - Dielectric spectroscopy. In: Thomas S, Thomas R, Zachariah AK, Mishra RK, eds. Spectroscopic methods for nanomaterials characterization. Amsterdam: Elsevier; 2017:p.237-299.
7.XaTek. ClotChip. 2021: https://www.clotchip.com/. Accessed 2022 Sep 20.
8.Canadian Hemophilia Society. Bleeding disorders. 2022; https://www.hemophilia.ca/bleeding-disorders/. Accessed 2022 Nov 2.
9.Moore L, Stelfox HT, Evans D, et al. Trends in injury outcomes across Canadian trauma systems. JAMA Surgery. 2017;152(2):168-174. PubMed
10.Thrombosis Canada. National survey reveals Canadians’ limited knowledge about thrombosis, risk factors and warning signs. 2018 Oct 11; https://thrombosiscanada.ca/national-survey-reveals-canadians-limited-knowledge-about-thrombosis-risk-factors-and-warning-signs/. Accessed 2022 Nov 2.
11.Point-of-care analyzers, coagulation; hematology; urine. (ECRI Comparative data). Plymouth Meeting (PA): ECRI Institute; 2021: https://www.ecri.org/ (subscription required). Accessed 2022 Sep 13.
12.Mohammadi Aria M, Erten A, Yalcin O. Technology advancements in blood coagulation measurements for point-of-care diagnostic testing. Front. 2019;7:395. PubMed
13.Diamond SL, Rossi JM. Point of care whole blood microfluidics for detecting and managing thrombotic and bleeding risks. Lab on a Chip. 2021;21(19):3667-3674. PubMed
14.Pourang S, Sekhon UDS, Disharoon D, et al. Assessment of fibrinolytic status in whole blood using a dielectric coagulometry microsensor. Biosens Bioelectron. 2022;210:114299. PubMed
15.Murphy GJ, Mumford AD, Rogers CA, et al. Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials. NIHR Journals Library. 2017;5(17):09.
16.Maji D, Opneja A, Suster MA, et al. Monitoring DOACs with a novel dielectric microsensor: a clinical study. Thromb Haemost. 2021;121(1):58-69. PubMed
17.Government of Canada. Health Canada. 2022; https://www.canada.ca/en/health-canada.html.
18.Suster MA, Maji D, Nayak LV, et al. A novel point-of-care whole blood coagulation assay to monitor emicizumab therapy in patients with hemophilia. Conference poster presented at: 60th ASH Annual Meeting; 2018 Dec 1-4; San Diego, CA. Blood. 2018;132(Suppl 1):2475.
19.Ahuja SP, Suster MA, Maji D, et al. Assessment of a novel dielectric microsensor for monitoring coagulation factor therapy in children with hemophilia with and without inhibitors. Conference poster presented at: 59th ASH Annual Meeting; 2017 Dec 9-12; Atlanta, GA. Blood. 2017;130(Supplement 1):1062.
20.Tien HC SF, Tremblay LN, Rizoli SB, Brenneman FD. Preventable deaths from hemorrhage at a level I Canadian trauma center. J Trauma. 2007 62(1):142-146. PubMed
21.Maji D, Nayak L, Martin J, et al. A novel, point-of-care, whole-blood assay utilizing dielectric spectroscopy is sensitive to coagulation factor replacement therapy in haemophilia A patients. Haemophilia. 2019;25(5):885-892. PubMed
22.Maji D, Suster MA, Sridhar DC, et al. Assessment of bleeding phenotype in hemophilia a by a novel point-of-care global assay. Conference abstract presented at: 61st ASH Annual Meeting; 2019 Dec 7-10; Orlando, FL. Blood. 2019;134(Suppl 1).
23.Pourang S, Suster MA, Mohseni P, Nayak LV. Assessment of hypercoagulable state in whole blood in sepsis patients using a novel microfluidic dielectric sensor. Blood. 2021;138(Suppl 1):1882.
24.Pourang S, Suster M, Maji D, et al. A novel point-of-care whole blood coagulation assay to screen for hemostatic defects. Conference abstract presented at: ISTH 2020 Congress; 2020 July 12-14; Virtual Congress. Res Pract Thromb Haemost. 2020;4(suppl 1):314.
25.Saha A, Bajpai A, Krishna V, Bhattacharya S. Evolving paradigm of prothrombin time diagnostics with its growing clinical relevance towards cardio-compromised and COVID-19 affected population. Sensors (Basel). 2021;21(8):09.
26.Wool GD. Benefits and pitfalls of point-of-care coagulation testing for anticoagulation management: an ACLPS Critical Review. Am J Clin Pathol. 2018;151(1):1-17. PubMed
27.Williams NX, Carroll B, Noyce SG, et al. Fully printed prothrombin time sensor for point-of-care testing. Biosens Bioelectron. 2021;172:112770. PubMed
28.Roka-Moiia Y, Bozzi S, Ferrari C, et al. The MICELI (MICrofluidic, ELectrical, Impedance): prototyping a point-of-care impedance platelet aggregometer. Int J Mol Sci. 2020;21(4):11. PubMed
29.Harder S, Santos SMD, Krozer V, Moll J. Surface acoustic wave-based microfluidic coagulation device for monitoring anticoagulant therapy. Semin Thromb Hemost. 2019;45(3):253-258. PubMed
30.Ferguson S. Development of a point of care aptamer-based coagulopathy sensor. Transfusion. 2018;58(Supplement 2):145A.
31.Case Western Reserve University. TraumaChekTM: Next step in life-saving blood-assessment technology. 2021: https://thedaily.case.edu/traumachektm-next-step-in-life-saving-blood-assessment-technology/. Accessed 2022 Oct 27.
32.Cision PRNewswire. XaTek, in cooperation with US Navy, to develop ruggedized ClotChip. 2020; https://www.prnewswire.com/news-releases/xatek-in-cooperation-with-us-navy-to-develop-ruggedized-clotchip-301081590.html. Accessed 2022 Oct 26.
33.University Hospitals. New tool being tested at UH to help boost trauma survival: device supported by $4.8 million DOD grant expected to save lives from trauma-induced coagulopathy. 2021 Sep 13; https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2021/09/new-tool-being-tested-at-uh-to-help-boost-trauma-survival. Accessed 2022 Oct 27.
34.XaTek ClotChip. Trials. 2021; https://www.clotchip.com/trials/. Accessed 2022 Oct 28.
ISSN: 2563-6596
Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up to date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.
CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.
This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.
Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third-party supplier of information.
This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.
This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.
The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.
About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.
Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
Questions or requests for information about this report can be directed to Requests@CADTH.ca.