1、Point-Of-Care Coagulation Testing:What is it?Why do we do it?Where are we going?John A.SaavedraInternational Sales ManagerInternational Technidyne Corporation(ITC)Edison,New Jersey,USA.What is Point of Care Testing?lAccording to CAP(College of American Pathologists):testing performed at the bedsiden
2、ot in fixed dedicated spacelPerformed by a large number of different non-laboratory healthcare personnellUtilizes portable devices or simple reagent kits different from those used in the primary laboratory.Why Test Coagulation?lMonitor anticoagulation therapyHeparin and Warfarin are monitoredlBoth h
3、ave highly variable patient dose response.lA therapeutic dose for patient AThrombotic dose for patient BHemorrhagic dose for patient ClDetermine patients hemostatic status.Why Point-Of-Care Testing?lPrompt Turn Around TimelImproved Clinical OutcomelReduced Length of StaylStandardizationlImproved,tim
4、ely patient care.Benefit-Immediate Turn AroundlWhen is Turn Around ImportantOperating Room and Cath LabICU/CCU Dose AdjustmentsEmergency Room.Immediate Turn AroundFitch,et.al,J.Clin Monit&Comput.1999.15:197-204.Reduced Turn Around TimelPost Surgical PatientsReduced blood lossReduced transfusion requ
5、irementslHeparin DripResults Obtained Prior to Next Scheduled Test Fewer,More Rapid Dosage AdjustmentsReduction in Length of StaylOverall cost reduction.POC Coagulation Testing Analyzers lHEMOCHRON ResponselHEMOCHRON Jr.II/SignaturelProTimelMedtronic HMS/HemoTec ACT IIlRoche CoaguChek/CoaguChek Prol
6、Bayer RapidPointli-STATlOthers.Point of Care Coagulation TestinglTest MenuACT-multiple activatorsDosing Assays for Open Heart SurgerylHeparin and ProtamineAPTT-fresh or citrated bloodPT-fresh or citrated bloodFibrinogenTT-thrombin time.Point-Of-Care Coagulation TestinguClinical Applications Operatin
7、g RoomlCardiac SurgerylInterventional Cardiology and RadiologyCritical Care Satellite SiteslDialysislECMOlEmergency RoomlAnticoagulation Clinic.What do we use an ACT for?Maintain BalanceBleeding ThrombosisHeparinRapid Anticoagulant EffectIndividual sensitivities vary significantlyPotency differences
8、Source:Bovine or PorcineLot to Lot variabilityRapidly Reversible with Protamine.Why are there so many different ACTs?.Monitoring Heparin with ACTlBenefitsIndustry Standard Since 1970 Hemochron pioneered ACT testing in 1969Recommended as primary method in AmSECT guidelines(perfusion)Easy to runInexpe
9、nsive.Monitoring Heparin with ACTlDisadvantagesEach system yields somewhat different numbersHigh sensitivity to hypothermia and hemodilution(with exceptions)Little correlation to heparin level in pediatric patients.Monitoring during Open Heart Surgery lData from clinical evaluation,on file,ITC.Monit
10、oring during Open Heart SurgerylData from clinical evaluation,on file,ITC.Pharmaceutical InterventionlAmicar or Transexamic AcidNo effect on standard celite ACTContinued debate on efficacylMultiple reports of reduction in post-operative blood loss and reduced transfusion requirements.Pharmaceutical
11、InterventionlAprotininSignificant elevation of celite ACTTwo dosing regimenslFull Hammersmith2 x 106 KIU loading dose;2 x 106 KIU pump prime;0.5 x 106 KIU/hr infusion lHalf Hammersmith1 x 106 KIU loading dose;1 x 106 KIU pump prime;0.25 x 106 KIU/hr infusion.ACT Monitoring with Aprotinin TreatmentlC
12、elite ACTNot recommendedStill used with target times of 750 secondslKaolin ACTUnaffected by moderate doses of aprotininUsed with target times of 480 secondslACT+Unaffected by ALL doses of aprotininUsed with target times of 400 seconds.ACT Monitoring with Aprotinin TreatmentData from clinical evaluat
13、ion,on file,ITC.Other Point-Of-Care Coagulation Testing in the Operating RoomlAPTT&PTPre-and post-procedural screeninglFibrinogenPre-and post-procedural screeninglDosing AssaysIndividualized heparin and protamine dose lHEMOCHRON HRT/PRTlHepcon HMS.Managing Heparin and Protamine DosinglWhy is managem
14、ent important?Traditional dosing regimens recommend fixed drug doses by body weight.For most patients,this regimen provides adequate anticoagulation.lRegimen does not account for patients whose response to heparin is different than the average patient.Patients differ in their response to heparin;som
15、e patients may be resistant or sensitive to heparinlThey can represent 20-40%of patient population.Managing Heparin and Protamine DosinglHeparin Resistance:Repeated exposure to heparin(from previous procedures)may reduce patients response to the druglPatient requires a higher dose of heparin in orde
16、r to obtain the same anticoagulant effect.Managing Heparin and Protamine DosinglHeparin Sensitivity:Patients response to heparin is greater than the average patient of the same height,weight and gender.lPatient requires a lower heparin dose to obtain the same anticoagulant effect.Managing Heparin an
17、d Protamine DosinglBenefits:Individualizes heparin dose for sensitive and resistant patientsReduces use of blood products needed for post-operative transfusionslJOBES DR,et al.1995.INCREASED ACCURACY AND PRECISION OF HEPARIN AND PROTAMINE DOSING REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN PAT
18、IENTS UNDERGOING PRIMARY CARDIAC OPERATIONS.J THORAC CARDIOVASC SURG 110:36-45 .Managing Heparin and Protamine DosinglBenefits:Reduces potential for protamine dose side effectslProtamine reduced by average of 30%ZUCKER ML.,et al.1997.UTILITY OF IN VITRO HEPARIN AND PROTAMINE TITRATION FOR DOSING DUR
19、ING CARDIOPULMONARY BYPASS SURGERY.J EXTRA-CORP TECH.29:176-180.Cost SavingsJOBES D,et al.1996.COST EFFECTIVE MANAGEMENT OF HEPARIN/PROTAMINE IN CP BYPASS:ANALYSIS BY TYPE OF SURGERY.ANESTHES 85:3A.Other Point-Of-Care Coagulation Testing in the Operating RoomlHeparin neutralization verificationEnsur
20、e complete removal of circulating heparinlaPTTlPDA-O-ACT basedlTT/HNTT-Thrombin Time based.Clinical Studies nReduced Blood Loss/TransfusionUse of HRT and PRT(RxDx System)lJobes,D.et.al.,1995.J.Thorac.Cardiovasc.Surg.lReduced CostResulting from POC AssaysRxDx combined with TT/HNTTlJobes,D.et.al.,1996
21、.Am Soc Anesth Mtg.Clinical StudiesnReduced Complication RatesTT/HNTTRe-Exploration for Bleeding Reduced from 2.5%to 1.1%Re-Exploration for Coagulopathy Reduced from 1.0%to 0.0%Jobes,et.al.1997,NACB Presentation,Phila,PA.Point-Of-Care Coagulation TestinguClinical Applications Operating RoomlCardiac
22、SurgerylInterventional Cardiology and RadiologyCritical Care Satellite SiteslDialysislECMOlEmergency RoomlAnticoagulation Clinic.Critical CarelACTDetermine when to pull the femoral sheath lHigh ACT values indicate the presence of heparin.Premature sheath pull can lead to bleeding complications.Delay
23、ed removal can increase time in both the CCU and hospitallTarget ACT set at each siteVaries from 150 sec to 250 secondMonitor heparin therapylTarget times determined by each facilityTargets usually set as 1.5-2x baseline ACT values(180-240 seconds).Critical CarelAPTTLaboratory or Point of CareHigh A
24、PTT values indicate the presence of heparin or underlying coagulopathyDetermine when to pull the femoral sheath lTarget times determined by each facility.Monitor heparin therapylTarget times determined by each facilityTargets are set as 1.5-2x baseline50-80 secondslMonitor during heparin/coumadin cr
25、oss-over.Heparin versus Warfarin.What Do the Test Results Mean?lPTLaboratory or Point of Care Monitor warfarin therapyMonitor heparin/warfarin crossoverlTarget times are set by International Normalized Ratio(INR)ISI=international Sensitivity IndexlINR target ranges are specified by patient populatio
26、nsprophylactic therapy for DVT:INR=2.0-3.0artificial heart valve:INR=3.0-4.0.Will Results Match the Lab?Probably notbut they WILL correlate.Why?lPoint of CareWhole BloodNo Added AnticoagulantNo DilutionNo Preanalytical DelaylStandard LaboratoryPlatelet Poor PlasmaSodium Citrate Anticoagulant1:9 Dilu
27、tionVariable Preanalytical Delay.Correlations with different systems.Signature INR vs Lab.Point-Of-Care Coagulation TestinguClinical Applications Operating RoomlCardiac SurgerylInterventional Cardiology and RadiologyCritical Care Satellite SiteslDialysislECMOlEmergency RoomlAnticoagulation Clinic.Di
28、alysis/ECMOlACT used to monitor heparinUse P214 glass activated ACT tube or ACT-LR cuvetteTargets generally 180-220 secondslBetter Control of Anticoagulation Leads to Increased Dialyzer ReusePotential for Long Term Cost SavingsNo Compromise in Dialysis Efficacy(Kt/V)lOuseph,R.et.al.Am J Kidney Dis 3
29、5:89-94;2000.Emergency RoomlACT;aPTT;PT;FibrinogenlImmediate Identification of CoagulopathiesOptimization of Critical Decision PathwayslACT Allows Early Detection of Traumatic CoagulopathyAllows Early Treatment DecisionsAids Damage Control DecisionslAucar,J.et.al.1998 SW Surgeons CongresslOptimize S
30、taffing During Off Hours.Anticoagulation ClinicslResults Available While Patient is PresentImproved Anticoagulation ManagementImproved Standard of CareStaff EfficiencylImmediate Retesting(if needed)Fingerstick SamplinglSame System for Clinic and Home Bound PatientsStandardized ISI(Test System Specif
31、ic).Anticoagulation ClinicslPotential for Self-TestingHigh Risk PatientsPatients Who Travel FrequentlyHome-BoundPatients in Rural Areas Far from CliniclImproved Outcomes Through More Frequent TestinglAnsell,J.1997 ISTH Mtg.lBecker,D.et.al.1997 Am Coll Cardiol Mtg.Where we arelPoint of Care Coagulati
32、on Testing Has Measurable Clinical BenefitsPatient OutcomeCost Reduction.Where are we going?lImproved,User-Friendly SystemsMicrosampleMinimal training requiredSimple Quality ControllElectronic controlslUnitized controlSimplify record keepinglData storage in instrumentlTransfer of data to computer or Hospital Information System/Laboratory Information System.HEMOCHRON Point-of-Care Coagulation Systems.