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1、Point-Of-Care Coagulation Testing:What is it? Why do we do it?Where are we going?,John A. Saavedra,International Sales ManagerInternational Technidyne Corporation (ITC)Edison, New Jersey, USA,1,教学资料,Point-Of-Care Coagulation Test,What is Point of Care Testing?,According to CAP (College of American P
2、athologists):testing performed at the bedsidenot in fixed dedicated spacePerformed by a large number of different non-laboratory healthcare personnelUtilizes portable devices or simple reagent kits different from those used in the primary laboratory.,2,教学资料,What is Point of Care Testing?,Why Test Co
3、agulation?,Monitor anticoagulation therapyHeparin and Warfarin are monitoredBoth have highly variable patient dose response.A therapeutic dose for patient AThrombotic dose for patient BHemorrhagic dose for patient CDetermine patients hemostatic status,3,教学资料,Why Test Coagulation?Monitor a,Why Point-
4、Of-Care Testing?,Prompt Turn Around TimeImproved Clinical OutcomeReduced Length of StayStandardizationImproved, timely patient care,4,教学资料,Why Point-Of-Care Testing?Prom,Benefit - Immediate Turn Around,When is Turn Around ImportantOperating Room and Cath LabICU/CCU Dose AdjustmentsEmergency Room,5,教
5、学资料,Benefit - Immediate Turn Arou,Immediate Turn Around,Fitch, et.al, J. Clin Monit & Comput. 1999. 15:197-204,6,教学资料,Immediate Turn AroundFitch, et,Reduced Turn Around Time,Post Surgical PatientsReduced blood lossReduced transfusion requirementsHeparin DripResults Obtained Prior to Next Scheduled T
6、est Fewer, More Rapid Dosage AdjustmentsReduction in Length of StayOverall cost reduction,7,教学资料,Reduced Turn Around TimePost S,POC Coagulation Testing Analyzers,HEMOCHRON ResponseHEMOCHRON Jr. II / SignatureProTimeMedtronic HMS / HemoTec ACT IIRoche CoaguChek / CoaguChek ProBayer RapidPointi-STATOt
7、hers,8,教学资料,POC Coagulation Testing Analyz,Point of Care Coagulation Testing,Test MenuACT - multiple activatorsDosing Assays for Open Heart SurgeryHeparin and ProtamineAPTT - fresh or citrated bloodPT - fresh or citrated bloodFibrinogenTT - thrombin time,9,教学资料,Point of Care Coagulation Test,Point-O
8、f-Care Coagulation Testing,Clinical Applications Operating RoomCardiac SurgeryInterventional Cardiology and RadiologyCritical Care Satellite SitesDialysisECMOEmergency RoomAnticoagulation Clinic,10,教学资料,Point-Of-Care Coagulation Test,What do we use an ACT for?,Maintain BalanceBleeding ThrombosisHepa
9、rinRapid Anticoagulant EffectIndividual sensitivities vary significantlyPotency differencesSource: Bovine or PorcineLot to Lot variabilityRapidly Reversible with Protamine,11,教学资料,What do we use an ACT for?Main,Why are there so many different ACTs?,12,教学资料,Why are there so many differen,Monitoring H
10、eparin with ACT,BenefitsIndustry Standard Since 1970 Hemochron pioneered ACT testing in 1969Recommended as primary method in AmSECT guidelines (perfusion)Easy to runInexpensive,13,教学资料,Monitoring Heparin with ACTBen,Monitoring Heparin with ACT,DisadvantagesEach system yields somewhat different numbe
11、rsHigh sensitivity to hypothermia and hemodilution (with exceptions)Little correlation to heparin level in pediatric patients,14,教学资料,Monitoring Heparin with ACTDis,Monitoring during Open Heart Surgery,Data from clinical evaluation, on file, ITC,15,教学资料,Monitoring during Open Heart S,Monitoring duri
12、ng Open Heart Surgery,Data from clinical evaluation, on file, ITC,16,教学资料,Monitoring during Open Heart S,Pharmaceutical Intervention,Amicar or Transexamic AcidNo effect on standard celite ACTContinued debate on efficacyMultiple reports of reduction in post-operative blood loss and reduced transfusio
13、n requirements,17,教学资料,Pharmaceutical InterventionAmi,Pharmaceutical Intervention,AprotininSignificant elevation of celite ACTTwo dosing regimensFull Hammersmith2 x 106 KIU loading dose; 2 x 106 KIU pump prime; 0.5 x 106 KIU/hr infusion Half Hammersmith1 x 106 KIU loading dose; 1 x 106 KIU pump prim
14、e; 0.25 x 106 KIU/hr infusion,18,教学资料,Pharmaceutical InterventionApr,ACT Monitoring with Aprotinin Treatment,Celite ACTNot recommendedStill used with target times of 750 secondsKaolin ACTUnaffected by moderate doses of aprotininUsed with target times of 480 secondsACT+Unaffected by ALL doses of apro
15、tininUsed with target times of 400 seconds,19,教学资料,ACT Monitoring with Aprotinin,ACT Monitoring with Aprotinin Treatment,Data from clinical evaluation, on file, ITC,20,教学资料,ACT Monitoring with Aprotinin,Other Point-Of-Care Coagulation Testing in the Operating Room,APTT & PTPre- and post-procedural s
16、creeningFibrinogenPre- and post-procedural screeningDosing AssaysIndividualized heparin and protamine dose HEMOCHRON HRT / PRTHepcon HMS,21,教学资料,Other Point-Of-Care Coagulatio,Managing Heparin and Protamine Dosing,Why is management important?Traditional dosing regimens recommend fixed drug doses by
17、body weight. For most patients, this regimen provides adequate anticoagulation.Regimen does not account for patients whose response to heparin is different than the average patient.Patients differ in their response to heparin; some patients may be resistant or sensitive to heparinThey can represent
18、20 - 40% of patient population,22,教学资料,Managing Heparin and Protamine,Managing Heparin and Protamine Dosing,Heparin Resistance: Repeated exposure to heparin (from previous procedures) may reduce patients response to the drugPatient requires a higher dose of heparin in order to obtain the same antico
19、agulant effect,23,教学资料,Managing Heparin and Protamine,Managing Heparin and Protamine Dosing,Heparin Sensitivity: Patients response to heparin is greater than the average patient of the same height, weight and gender. Patient requires a lower heparin dose to obtain the same anticoagulant effect.,24,教
20、学资料,Managing Heparin and Protamine,Managing Heparin and Protamine Dosing,Benefits:Individualizes heparin dose for sensitive and resistant patientsReduces use of blood products needed for post-operative transfusionsJOBES DR, et al. 1995. INCREASED ACCURACY AND PRECISION OF HEPARIN AND PROTAMINE DOSIN
21、G REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN PATIENTS UNDERGOING PRIMARY CARDIAC OPERATIONS. J THORAC CARDIOVASC SURG 110: 36-45,25,教学资料,Managing Heparin and Protamine,Managing Heparin and Protamine Dosing,Benefits:Reduces potential for protamine dose side effectsProtamine reduced by average
22、 of 30%ZUCKER ML., et al. 1997. UTILITY OF IN VITRO HEPARIN AND PROTAMINE TITRATION FOR DOSING DURING 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
23、: 3A,26,教学资料,Managing Heparin and Protamine,Other Point-Of-Care Coagulation Testing in the Operating Room,Heparin neutralization verificationEnsure complete removal of circulating heparinaPTTPDA-O - ACT basedTT / HNTT - Thrombin Time based,27,教学资料,Other Point-Of-Care Coagulatio,Clinical Studies,Redu
24、ced Blood Loss/TransfusionUse of HRT and PRT (RxDx System)Jobes, D. et. al., 1995. J. Thorac.Cardiovasc.Surg. Reduced CostResulting from POC AssaysRxDx combined with TT / HNTTJobes, D. et. al., 1996. Am Soc Anesth Mtg.,28,教学资料,Clinical Studies Reduced Blood,Clinical Studies,Reduced Complication Rate
25、sTT /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.,29,教学资料,Clinical StudiesReduced Compli,Point-Of-Care Coagulation Testing,Clinical Applications Operating RoomCardiac SurgeryInterve
26、ntional Cardiology and RadiologyCritical Care Satellite SitesDialysisECMOEmergency RoomAnticoagulation Clinic,30,教学资料,Point-Of-Care Coagulation Test,Critical Care,ACTDetermine when to pull the femoral sheath High ACT values indicate the presence of heparin.Premature sheath pull can lead to bleeding
27、complications.Delayed removal can increase time in both the CCU and hospitalTarget ACT set at each siteVaries from 150 sec to 250 secondMonitor heparin therapyTarget times determined by each facilityTargets usually set as 1.5-2x baseline ACT values (180 - 240 seconds).,31,教学资料,Critical CareACT31教学资料
28、,Critical Care,APTTLaboratory or Point of CareHigh APTT values indicate the presence of heparin or underlying coagulopathyDetermine when to pull the femoral sheath Target times determined by each facility. Monitor heparin therapyTarget times determined by each facilityTargets are set as 1.5-2x basel
29、ine50-80 secondsMonitor during heparin / coumadin cross-over,32,教学资料,Critical CareAPTTLaboratory o,Heparin versus Warfarin,33,教学资料,Heparin versus Warfarin33教学资料,What Do the Test Results Mean?,PTLaboratory or Point of Care Monitor warfarin therapyMonitor heparin/warfarin crossoverTarget times are set
30、 by International Normalized Ratio (INR)ISI = international Sensitivity IndexINR target ranges are specified by patient populationsprophylactic therapy for DVT: INR= 2.0 - 3.0artificial heart valve: INR=3.0 - 4.0,34,教学资料,What Do the Test Results Mean?,Will Results Match the Lab?,Probably notbut they
31、 WILL correlate,35,教学资料,Will Results Match the Lab?Pro,Why?,Point of CareWhole BloodNo Added AnticoagulantNo DilutionNo Preanalytical Delay,Standard LaboratoryPlatelet Poor PlasmaSodium Citrate Anticoagulant1:9 DilutionVariable Preanalytical Delay,36,教学资料,Why?Point of CareStandard Labo,Correlations
32、with different systems,37,教学资料,Correlations with different sy,Signature INR vs Lab,38,教学资料,Signature INR vs Lab38教学资料,Point-Of-Care Coagulation Testing,Clinical Applications Operating RoomCardiac SurgeryInterventional Cardiology and RadiologyCritical Care Satellite SitesDialysisECMOEmergency RoomAnt
33、icoagulation Clinic,39,教学资料,Point-Of-Care Coagulation Test,Dialysis / ECMO,ACT used to monitor heparinUse P214 glass activated ACT tube or ACT-LR cuvetteTargets generally 180 - 220 secondsBetter Control of Anticoagulation Leads to Increased Dialyzer ReusePotential for Long Term Cost SavingsNo Compro
34、mise in Dialysis Efficacy (Kt/V)Ouseph, R. et.al. Am J Kidney Dis 35:89-94; 2000,40,教学资料,Dialysis / ECMOACT used to mon,Emergency Room,ACT; aPTT; PT; FibrinogenImmediate Identification of CoagulopathiesOptimization of Critical Decision PathwaysACT Allows Early Detection of Traumatic CoagulopathyAllo
35、ws Early Treatment DecisionsAids Damage Control DecisionsAucar, J. et.al. 1998 SW Surgeons CongressOptimize Staffing During Off Hours,41,教学资料,Emergency RoomACT; aPTT; PT; F,Anticoagulation Clinics,Results Available While Patient is PresentImproved Anticoagulation ManagementImproved Standard of CareS
36、taff EfficiencyImmediate Retesting (if needed)Fingerstick SamplingSame System for Clinic and Home Bound PatientsStandardized ISI (Test System Specific),42,教学资料,Anticoagulation ClinicsResults,Anticoagulation Clinics,Potential for Self-TestingHigh Risk PatientsPatients Who Travel FrequentlyHome-BoundP
37、atients in Rural Areas Far from ClinicImproved Outcomes Through More Frequent TestingAnsell, J. 1997 ISTH Mtg.Becker, D. et.al. 1997 Am Coll Cardiol Mtg.,43,教学资料,Anticoagulation ClinicsPotenti,Where we are,Point of Care Coagulation Testing Has Measurable Clinical BenefitsPatient OutcomeCost Reductio
38、n,44,教学资料,Where we arePoint of Care Coag,Where are we going?,Improved, User-Friendly SystemsMicrosampleMinimal training requiredSimple Quality ControlElectronic controlsUnitized controlSimplify record keepingData storage in instrumentTransfer of data to computer or Hospital Information System / Laboratory Information System,45,教学资料,Where are we going?Improved, U,HEMOCHRON Point-of-Care Coagulation Systems,46,教学资料,HEMOCHRON Point-of-Care Coagul,
