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1、.,1,Point-Of-Care Coagulation Testing:What is it? Why do we do it?Where are we going?,John A. Saavedra,International Sales Manager International Technidyne Corporation (ITC) Edison, New Jersey, USA,.,2,What is Point of Care Testing?,According to CAP (College of American Pathologists): testing perfor

2、med at the bedside not in fixed dedicated space Performed by a large number of different non-laboratory healthcare personnel Utilizes portable devices or simple reagent kits different from those used in the primary laboratory.,.,3,Why Test Coagulation?,Monitor anticoagulation therapy Heparin and War

3、farin are monitored Both have highly variable patient dose response. A therapeutic dose for patient A Thrombotic dose for patient B Hemorrhagic dose for patient C Determine patients hemostatic status,.,4,Why Point-Of-Care Testing?,Prompt Turn Around Time Improved Clinical Outcome Reduced Length of S

4、tay Standardization Improved, timely patient care,.,5,Benefit - Immediate Turn Around,When is Turn Around Important Operating Room and Cath Lab ICU/CCU Dose Adjustments Emergency Room,.,6,Immediate Turn Around,Fitch, et.al, J. Clin Monit 2 x 106 KIU pump prime; 0.5 x 106 KIU/hr infusion Half Hammers

5、mith 1 x 106 KIU loading dose; 1 x 106 KIU pump prime; 0.25 x 106 KIU/hr infusion,.,19,ACT Monitoring with Aprotinin Treatment,Celite ACT Not recommended Still used with target times of 750 seconds Kaolin ACT Unaffected by moderate doses of aprotinin Used with target times of 480 seconds ACT+ Unaffe

6、cted by ALL doses of aprotinin Used with target times of 400 seconds,.,20,ACT Monitoring with Aprotinin Treatment,Data from clinical evaluation, on file, ITC,.,21,Other Point-Of-Care Coagulation Testing in the Operating Room,APTT some patients may be resistant or sensitive to heparin They can repres

7、ent 20 - 40% of patient population,.,23,Managing Heparin and Protamine Dosing,Heparin Resistance: Repeated exposure to heparin (from previous procedures) may reduce patients response to the drug Patient requires a higher dose of heparin in order to obtain the same anticoagulant effect,.,24,Managing

8、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.,.,25,Managing Heparin and Protamine Dosing,Benefits: Individualizes

9、 heparin dose for sensitive and resistant patients Reduces use of blood products needed for post-operative transfusions JOBES DR, et al. 1995. INCREASED ACCURACY AND PRECISION OF HEPARIN AND PROTAMINE DOSING REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN PATIENTS UNDERGOING PRIMARY CARDIAC OPERA

10、TIONS. J THORAC CARDIOVASC SURG 110: 36-45,.,26,Managing Heparin and Protamine Dosing,Benefits: Reduces potential for protamine dose side effects Protamine reduced by average of 30% ZUCKER ML., et al. 1997. UTILITY OF IN VITRO HEPARIN AND PROTAMINE TITRATION FOR DOSING DURING CARDIOPULMONARY BYPASS

11、SURGERY. J EXTRA-CORP TECH. 29: 176-180. Cost Savings JOBES D, et al. 1996. COST EFFECTIVE MANAGEMENT OF HEPARIN/PROTAMINE IN CP BYPASS: ANALYSIS BY TYPE OF SURGERY. ANESTHES 85: 3A,.,27,Other Point-Of-Care Coagulation Testing in the Operating Room,Heparin neutralization verification Ensure complete

12、 removal of circulating heparin aPTT PDA-O - ACT based TT / HNTT - Thrombin Time based,.,28,Clinical Studies,Reduced Blood Loss/Transfusion Use of HRT and PRT (RxDx System) Jobes, D. et. al., 1995. J. Thorac.Cardiovasc.Surg. Reduced Cost Resulting from POC Assays RxDx combined with TT / HNTT Jobes,

13、D. et. al., 1996. Am Soc Anesth Mtg.,.,29,Clinical Studies,Reduced Complication Rates TT /HNTT Re-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.,.,30,Point-Of-Care Coagulation Testing,Clin

14、ical Applications Operating Room Cardiac Surgery Interventional Cardiology and Radiology Critical Care Satellite Sites Dialysis ECMO Emergency Room Anticoagulation Clinic,.,31,Critical Care,ACT Determine when to pull the femoral sheath High ACT values indicate the presence of heparin. Premature shea

15、th pull can lead to bleeding complications. Delayed removal can increase time in both the CCU and hospital Target ACT set at each site Varies from 150 sec to 250 second Monitor heparin therapy Target times determined by each facility Targets usually set as 1.5-2x baseline ACT values (180 - 240 secon

16、ds).,.,32,Critical Care,APTTLaboratory or Point of Care High APTT values indicate the presence of heparin or underlying coagulopathy Determine when to pull the femoral sheath Target times determined by each facility. Monitor heparin therapy Target times determined by each facility Targets are set as

17、 1.5-2x baseline 50-80 seconds Monitor during heparin / coumadin cross-over,.,33,Heparin versus Warfarin,.,34,What Do the Test Results Mean?,PTLaboratory or Point of Care Monitor warfarin therapy Monitor heparin/warfarin crossover Target times are set by International Normalized Ratio (INR) ISI = in

18、ternational Sensitivity Index INR target ranges are specified by patient populations prophylactic therapy for DVT: INR= 2.0 - 3.0 artificial heart valve: INR=3.0 - 4.0,.,35,Will Results Match the Lab?,Probably not but they WILL correlate,.,36,Why?,Point of Care Whole Blood No Added Anticoagulant No

19、Dilution No Preanalytical Delay,Standard Laboratory Platelet Poor Plasma Sodium Citrate Anticoagulant 1:9 Dilution Variable Preanalytical Delay,.,37,Correlations with different systems,.,38,Signature INR vs Lab,.,39,Point-Of-Care Coagulation Testing,Clinical Applications Operating Room Cardiac Surge

20、ry Interventional Cardiology and Radiology Critical Care Satellite Sites Dialysis ECMO Emergency Room Anticoagulation Clinic,.,40,Dialysis / ECMO,ACT used to monitor heparin Use P214 glass activated ACT tube or ACT-LR cuvette Targets generally 180 - 220 seconds Better Control of Anticoagulation Lead

21、s to Increased Dialyzer Reuse Potential for Long Term Cost Savings No Compromise in Dialysis Efficacy (Kt/V) Ouseph, R. et.al. Am J Kidney Dis 35:89-94; 2000,.,41,Emergency Room,ACT; aPTT; PT; Fibrinogen Immediate Identification of Coagulopathies Optimization of Critical Decision Pathways ACT Allows

22、 Early Detection of Traumatic Coagulopathy Allows Early Treatment Decisions Aids Damage Control Decisions Aucar, J. et.al. 1998 SW Surgeons Congress Optimize Staffing During Off Hours,.,42,Anticoagulation Clinics,Results Available While Patient is Present Improved Anticoagulation Management Improved Standard of Care Staff Efficiency Immediate Retesting (if needed) Fingerstick Sampling Same System for Clinic and Home Bound Patients Standardized ISI (Test Syst

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