The use of a HEMOCHRON JR. HEMONOX point of care test in monitoring the anticoagulant effects of XXXX during interventional coronary procedures.

@entity1 @entity2120
BACKGROUND: @entity2120 is increasingly used for the anticoagulation of @entity1 undergoing percutaneous coronary intervention (PCI). Several reports have suggested the utility of using point of care tests in monitoring the anticoagulation levels of @entity2120 in @entity1 undergoing PCI. The objective of this study was to evaluate a new point-of-care test (POCT) HEMONOX in monitoring the anticoagulant effect of @entity2120 in non citrated fresh whole blood samples from @entity1 undergoing elective PCI procedure. METHODS: Following IRB approval, blood samples were obtained from fifty-four @entity1 who received two sequential intravenous doses of @entity2120 ; 0.1 mg/kg followed 5 min later by 0.4 mg/kg for a total of 0.5 mg/kg. Blood was drawn at baseline and at 5, 10, 30 and 60 min post first bolus for evaluation in the clot-based POCT HEMONOX, ACT and aPTT and the chromogenic anti-Xa activity assay. RESULTS: HEMONOX clotting time (CT) at baseline was 62.6 +/- 6.2 secs, (n = 32) in healthy donors and statistically higher in PCI @entity1 (71.6 +/- 9.1 secs, p = 0.0001). The peak HEMONOX response that was always achieved at 10 min post bolus was >100 secs in all 54 @entity1 , of these 83% yielded CT >150 secs (range: 150-466). There was no detectable anti-Xa activity level at baseline while peak HEMONOX CT corresponded to therapeutic levels (0.85 +/- 0.14 U/ml; range: 0.61-1.34). Both HEMONOX CT and anti-Xa level significantly decreased at the time of sheath removal. HEMONOX CT at peak response suggested 3 @entity1 subgroups with different levels of sensitivity to @entity2120 : low, intermediate and high responders. The correlation between anti-Xa activity level and HEMONOX CT was >or=0.85 in each @entity1 subgroup when data from the 3 critical time points; baseline (absence of drug), peak response (10 min post bolus) and sheath removal (60 min post bolus) were analyzed. The correlation diminished to >or=0.83 when the analyses included data from all 5 time points [baseline, 5, 10, 30, and 60 min post bolus]. The HEMONOX test was the most sensitive POCT to measure the anticoagulant effects of @entity2120 . All @entity1 completed PCI successfully. CONCLUSION: The HEMONOX test may be able to guide anticoagulation with @entity2120 during PCI. The HEMONOX assay is a one step whole blood coagulation test performed on the HEMOCHRON Jr. Signature + POC system. The method was evaluated to monitor the anticoagulant level of @entity2120 in blood samples from @entity1 undergoing PCI after receiving an intravenous dose of 0.5 mg/kg. The results suggest a clear distinction of HEMONOX CT between the baseline value of untreated @entity1 and @entity1 achieving therapeutic @entity2120 levels.
