Hemochron Signature Elite

"Studies have shown feasibility of POCT in identifying blood samples containing clinically relevant DOAC plasma concentrations. Each POCT device has its own unique limitations. Knowledge about the POCT assays, time since last intake and type of DOAC enhances confidence in making appropriate therapeutic decisions. We propose an algorithm that could help guiding physicians in selecting an appropriate POCT system/assay in DOAC-related emergencies."

While factor XII deficiency poses a significant challenge for anticoagulation monitoring during cardiopulmonary bypass, this case highlights that predictable results are achievable. By utilizing the Hemochron Signature Elite with ACT + cartridges, clinicians can overcome the typical monitoring hurdles associated with this rare condition. This approach offers a reliable pathway for managing pediatric patients with factor XII deficiency, ensuring safe and effective bypass outcomes.

"Our study represents the first systematic evaluation of the HC-POCT in edoxaban-treated patients. Applying sufficiently low assay-specific cut-offs, the HC-POCT may not only be used to reliably rule out dabigatran and rivaroxaban, but also very low edoxaban concentrations in a blood sample. Because the assay-specific cut-offs were retrospectively defined, further investigation is warranted."

"Study results suggest that in-clinic anemia may be more prevalent among younger, female patients prescribed warfarin, and patients diagnosed with in-clinic anemia may be a risk factor for out-of-range INR. Pharmacists practicing in anticoagulation clinics can incorporate this information into patient care practice in efforts to maintain optimal management."

"In emergency situations POCT use may provide useful immediate information on dabigatran and rivaroxaban concentration."

"Our 2 patients receiving rivaroxaban had POC-INRs elevated beyond what was expected; these measurements were discordant from INRs simultaneously measured via the laboratory. A prospective evaluation assessing the accuracy of other commonly used POC-INR devices in patients receiving rivaroxaban would determine whether our findings extend to other devices. Until that time, laboratory measurement of INR or POC-INR using an INRatio device is recommended when patients' therapy is transitioned from rivaroxaban to warfarin."

"Both the ACT-LR and ACT+ tests of Hemochron Signature Elite device and the INTEM:HEPTEM CT ratio of ROTEM Sigma device have poor ability to detect residual heparin shortly after protamine administration."

"Available cross-validation data demonstrate substantial differences between ACT platforms [Hemochron, Medtronic ACT Plus and i-STAT]. Real-world heparin administration strategies and ACT targets vary markedly by platform. These findings challenge the assumption of universal ACT targets and highlight the need for platform-specific interpretation."

"ACTe and ACTr showed no correlation. Switching devices [Hemochron Response and Hemochron Signature Elite] without adjusting ACT thresholds leads to unnecessary UFH redosing, despite adequate anticoagulation as measured by anti-Xa levels.".

"The i-STAT analyzers produce more reproducible ACT results [than the Hemochron], but the target range should be lowered to 200 to 250 seconds. This range appears to provide adequate and safe heparin therapy, confirmed by anti-Xa assay results and clinical outcome."

"The Elite was more reliable, but the variation was higher for the Elite than the Response. The observed positive bias in the Response compared to the Elite could affect heparin administration during surgery making the two systems not interchangeable."

"Results obtained for both ACT-LR and ACT+ in all clinical settings in this study using the GEM Hemochron 100 are as accurate and more repeatable as those with the current clinically available Signature Elite. This increase in repeatability between instruments with simultaneously drawn and tested blood samples may answer some of the negative observations associated with the Signature Elite technology. The new technology associated with the GEM Hemochron 100 also offers a future POC coagulation platform, which may benefit clinicians and patient care in the POC setting with menu expansion."

"Each device [Instrumentation Laboratory Hemochron Elite (Hmch), Medtronic HMS Plus (HMS), Abbott i-STAT, and Helena Abrazo] had individual reproducibility and biases, which may impact peri-operative heparin management. Careful validation must be undertaken when adopting a different method as decision limits would be affected. Clinicians should also be cautious using ACT as the only indicator for full heparin reversal."

"We transitioned from Hemochron Response to Hemochron Signature Elite devices for monitoring anticoagulation in our congenital cardiac surgery practice using a new target ACT of >400 seconds. Transitioning to Elite ACT devices has provided the benefits of accelerated results, decreased potential variability between users, improved data management options, and a significant reduction in the blood volume required for regular ACT testing before and during CPB."

"Currently used ACT point-of-care devices [Hemochron Signature Elite and Abbott i-STAT] cannot be used interchangeably. Furthermore, our data question the reliability of the Hemochron in assessing adequacy of heparin anticoagulation monitoring for CPB."

"ACT monitoring with iSTAT offers good correlation between instruments and with the Hepcon ACT. Hepcon occupies a specific niche in cardiac operating departments because of its ability to provide additional information regarding heparin concentration; however, lack of suitable proficiency testing may impair its use. The iSTAT is a more reliable platform for broader, hospital-wide application."

"The present study demonstrates the necessity of a universal approach to POC ACT monitoring. The variability associated with the four systems [HMS, ACT-Plus, i-STAT, Hemochron] in this study is cogent evidence that the ACT alone is not indicative of the full extent of anticoagulation in an individual patient. Since variability is inherent in the devices, using a singular device to monitor ACT for all settings in which heparin is used therapeutically would eliminate the variability between devices. An approach to standardizing the ACT between different devices much like the way the INR was established would decrease the misleading margin of variability in ACT measurements. In instances where the ACT is variable, thus less reliable, keeping the heparin level consistent would withstand the inaccurate depiction of anticoagulation by ACT exclusive based anticoagulation management. Further studies need to be conducted to identify the potential benefit of standardizing the systems."

"The performance of ACT+ is equal to that of ACT-LR up to a concentration of 0.5 IU/mL, above which ACT+ is superior to ACT-LR, questioning the rationale for a specific low-range test. However, there is a significant bias between ACT-LR and ACT+ measurements that needs to be considered if switching from one test to the other."

While the Hemochron Signature Elite POC device offers convenience, its poor agreement with laboratory standards makes it an unreliable primary method for monitoring heparin in COVID-19 VV-ECMO patients. The significant variability and influence of physiological factors like platelet count and renal function suggest that this POC test lacks the necessary accuracy for critical anticoagulation management in this population.

"POCT-INR measurements based on our POCT concept are suitable to determine INR values in critical stroke patients. Nevertheless, outlier evaluation is mandatory."

While certain parameters like creatinine and lactate showed insufficient correlation, this study confirms that POC devices provide reliable real-time data for most hematology and biochemistry markers in critically ill patients. These devices effectively match laboratory standards for core clinical measurements, allowing for immediate bedside decision-making and significantly reducing treatment delays in intensive care settings.

"The results showed a lack of agreement between the INR-HC(®) and the aPTT-HC(®) measurements and the standard laboratory in the context of acute haemorrhage. The INR-HC(®) showed moderate performance as a decision-making tool to detect coagulopathy in the context of acute haemorrhage."