Assessing the Reliability of Hemonart® Device and its Tubes in Activated Coagulation Time (ACT) Measurement by Comparison with Routine Measurement Methods

INTRODUCTION Activated coagulation time (ACT) measurement is performed to monitor the level of anticoagulation provided by heparin during cardiopulmonary bypass, coronary angioplasty and dialysis. In this study, the newly developed device and the consumable ACT tubes of this device were compared with the current methods used in hospitals and its usability as a reliable product was evaluated. METHOD This study was carried out in the cardiovascular surgery operating room of Gazi University Medical Faculty Hospital after the approval of the ethics committee and the approval of the Turkish Medicines and Medical Devices Agency . A total of 100 patients over the age of 18 who received heparin during cardiac surgery were included in the study. In our routine practice, Hemochron device with cuvettes (Hemochron Signature, Spain) constituted the “Hemochron cuvette” group and Hemochron device with tubes (Hemochron Response, Spain) constituted the “Hemochron tube” group. Hemonart device and tubes (CompactOne 9 and BlacT-ACT tube) constituted the “Hemonart tube” group. Measurements made with the above 3 devices simultaneously; the baseline value before heparinization was repeated at 5th minute after heparinization, after the initiation of cardiopulmonary bypass, and 5 minutes after protamine administration. The correlation of the measurements obtained with the 3 devices was evaluated. RESULTS When basal ACT measurements were evaluated; The mean ACT of Hemonart tube was measured as 148.54±26.54 sec and Hemochron tube (122.67±16.38) and Hemochron cuvette (117.94±15.06) values were statistically significantly higher (p<0.0001, p<0.0001, respectively). When measurements after heparin and during cardiopulmonary bypass were evaluated; Hemonart tube and Hemochron tube mean ACT values were similar in both groups (p=0.356) but statistically higher than Hemochron cuvette values (p<0.0001, p=0.003, respectively). Mean ACT values of Hemonart tube following protamine administration were statistically significantly higher than Hemochron tube and Hemochron cuvette values (p<0.0001, p<0.0001, respectively). A positive correlation was found between the values measured with different devices at all measurement time points. The strongest correlation was found between Hemonart tube and Hemochron tube values at baseline, post-heparin, during cardiopulmonary bypass and following protamin administration (r=0.546, p<0.0001; r=0.512, p<0.0001; r=0.533, p<0.0001, r= 0.407, p=0.001, respectively). CONCLUSION It has been concluded that Hemonart brand devices and tubes can be used safely.