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Coagulation Testing What is it? Why do we need it POC? ITC Educational Services, Edison, NJ Marcia L. Zucker, Ph.D. Director of Clinical Research.

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Presentation on theme: "Coagulation Testing What is it? Why do we need it POC? ITC Educational Services, Edison, NJ Marcia L. Zucker, Ph.D. Director of Clinical Research."— Presentation transcript:

1 Coagulation Testing What is it? Why do we need it POC? ITC Educational Services, Edison, NJ Marcia L. Zucker, Ph.D. Director of Clinical Research

2 Coagulation Testing u Monitoring hemostasis Bleeding Clotting

3 Coagulation Testing u Monitoring therapy Intrinsic Pathway Extrinsic Pathway Common Pathway CLOT Heparin Coumadin Monitor with ACT / aPTT Monitor with PT Thrombolytics Monitor with TT / Fibrinogen

4 Coagulation is Complex Platelet Adhesion shape change release ADP release Platelet Aggregation Coagulation Fibrin formation 3 sec 10 sec 5 min

5 Coagulation is Complex

6 Common(?) Coagulation Tests u Laboratory PT.. aPTT TT.. Fib. –Anti Xa –Anti IIa –Factor Assays u Point of Care –ACT »Celite ® »Kaolin »Glass beads »Silica »thromboplastin

7 Differences in test methods u Point of Care –Whole Blood –No Added Anticoagulant –No Dilution –No Preanalytical Delay u Standard Laboratory –Platelet Poor Plasma –Sodium Citrate Anticoagulant –1:9 Dilution –Variable Preanalytical Delay

8 POC Coagulation Analyzers u HEMOCHRON 401 / 801 / Response u HEMOCHRON Jr. Signature u ProTime u Medtronic HMS / HemoTec ACT II u CoaguChek / CoaguChek Pro DM u Bayer RapidPoint u i-STAT u Others

9 POC Coag Analyzers Differ u Test methodology –Sample size and application –Sample measurement –Clot detection method »Enzyme detection method –Reagent composition –Results

10 Clinical Applications Operating Room –Cardiac Surgery –Interventional Cardiology and Radiology u Critical Care u Satellite Sites –Dialysis –ECMO –Emergency Room –Anticoagulation Clinic

11 Activated Clotting Time Intrinsic Pathway Extrinsic Pathway Common Pathway CLOT ACT

12 What do we use an ACT for? u Maintain Balance –Bleeding Thrombosis u Heparin –Rapid Anticoagulant Effect »Individual sensitivities vary significantly »Potency differences u Source: Bovine or Porcine u Lot to Lot variability –Rapidly Reversible with Protamine

13 Why are there so many different ACTs?

14 Monitoring - ACT u Benefits –Industry Standard Since 1970s –Recommended as primary method in AmSECT guidelines (perfusion) –Easy to run

15 Monitoring - ACT u Disadvantages –Each system yields different numbers –High sensitivity to hypothermia and hemodilution (with exceptions) –Little or no correlation to heparin level » especially true for pediatric patients

16 Heparinized ACT - CPB Data from Huffman, et.al AmSECT meeting

17 Monitoring in CPB - ACT u Data from clinical evaluation, on file, ITC

18 Pharmaceutical Intervention u Amicar or Tranexamic Acid –No effect on standard celite ACT –Continued debate on efficacy »Multiple reports u Reduction in post-operative blood loss u Reduced transfusion requirements

19 Pharmaceutical Intervention u Aprotinin –Significant elevation of celite ACT –Two dosing regimens »Full Hammersmith u 2 x 10 6 KIU loading dose; 2 x 10 6 KIU pump prime; 0.5 x 10 6 KIU/hr infusion »Half Hammersmith u 1 x 10 6 KIU loading dose; 1 x 10 6 KIU pump prime; 0.25 x 10 6 KIU/hr infusion

20 ACT Monitoring-Aprotinin Treatment u Celite ACT –Not recommended –Still used with target times of >750 seconds u Kaolin ACT –Unaffected by moderate doses of aprotinin –Used with target times of > 480 seconds u ACT+ –Unaffected by ALL doses of aprotinin –Used with target times of > 400 seconds

21 ACT Monitoring -Aprotinin Treatment Data from clinical evaluation, on file, ITC

22 Alternative Monitoring - Aprotinin u HiTT - High Dose Thrombin Time Adapted from Huyzen, et. al. J.CardioThorac. Vasc. Anesth. 8:153, 1994

23 Alternative Monitoring - Aprotinin Adapted from Huyzen, et. al. J.CardioThorac.Vasc.Anesth. 8:153, 1994

24 Thrombin Time Intrinsic Pathway Extrinsic Pathway Common Pathway CLOT TT

25 Other POC Coag in the OR u aPTT / PT –Pre- and post-procedural screening u Fibrinogen –Pre- and post-procedural screening u Dosing Assays –Customize heparin and protamine for each patient »HEMOCHRON HRT / PRT »Hepcon HMS »RapidPoint

26 Other POC Coag in the OR u Heparin neutralization verification –Ensure complete removal of circulating heparin »aPTT »PDA-O - ACT based »TT / HNTT - Thrombin Time based »heparinase ACT

27 Outcome studies - POC in OR u Reduced Blood Loss/Transfusion –Use of HRT and PRT (RxDx System) »Jobes, D. et. al., J.Thorac.Cardiovasc.Surg. u Reduced Cost –Resulting from POC Assays –RxDx combined with TT / HNTT »Jobes, D. et. al., Am Soc Anesth Mtg.

28 Outcome studies - POC in OR u 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.

29 Clinical Applications Operating Room –Cardiac Surgery –Interventional Cardiology and Radiology u Critical Care u Satellite Sites –Dialysis –ECMO –Emergency Room –Anticoagulation Clinic

30 Procedures u Diagnostic –Catheterization »locate and map vessel blockage(s) »determine need for interventional procedures –Electrophysiology u Interventional –Balloon angioplasty –Arthrectomy (roto-rooter)

31 Diagnostic – Low dose heparin u Catheterization and Electrophysiology – unit bolus dose –frequently not monitored –if monitored – »ACT »aPTT

32 Interventional – Moderate dose u Angioplasty and Arthrectomy –10,000 unit bolus dose or – mg/kg –target ACT seconds »unless platelet inhibitors used u 200 – 300 in presence of ReoPro

33 Why use platelet inhibitors?

34 Angioplasty promotes aggregation

35

36 Platelet Inhibitors u ReoPro –elevates ACTs –target time = 250 sec with ReoPro »determined using FTCA510 tube u Integrelin –No reported effects on ACT u Aggrastat –No reported effects on ACT

37 Clinical Applications Operating Room –Cardiac Surgery –Interventional Cardiology and Radiology u Critical Care u Satellite Sites –Dialysis –ECMO –Emergency Room –Anticoagulation Clinic

38 ACT or aPTT u Determine when to pull the femoral sheath –Premature sheath pull can lead to bleeding. –Delayed removal can increase time in CCU. –Target set at each site. »ACT targets range from 150 – 220 seconds »aPTT targets range from 40 – 70 seconds

39 ACT or aPTT u Monitor heparin therapy –Target times determined by each facility –APTT outcome study »Reduce time to result (112 vs <5 minute) »Reduce time to stabilization »Reduce dose adjustments »Reduce length of stay »By using POC aPTT instead of lab u Poster at AACC 2000 – Staikos, et.al.

40 What did it say? u Mean time to lab result = 112 min –Mean time to POC result <5 min u Fewer dose adjustments needed in POC group to reach therapeutic level u Shorter time required to reach therapeutic level in POC group u Fewer dose changes in POC group

41 Activated Partial Thromboplastin Time Intrinsic Pathway Extrinsic Pathway Common Pathway CLOT APTT

42 u NOT a PTT –PTT is the predecessor of the aPTT –Not used anymore u Laboratory or Point of Care u High APTT values 1.the presence of heparin 2.underlying coagulopathy u Monitor heparin / coumadin ® cross-over Activated Partial Thromboplastin Time

43 Heparin versus Warfarin

44 Prothrombin Time Intrinsic Pathway Extrinsic Pathway Common Pathway CLOT PT

45 Prothrombin Time u Monitor warfarin therapy u Monitor heparin/warfarin crossover u Target times are set by International Normalized Ratio (INR) ISI = international Sensitivity Index –INR target ranges are specified by patient populations »prophylactic therapy for DVT: INR= »artificial heart valve: INR=

46 Will POC Results Match the Lab? (Probably Not) but it WILL Correlate

47 Correlate Does Not Mean Match

48 Coag is NOT Chemistry

49 Compare for your site. Same System / Multiple Sites

50 Are differences important? u Sometimes no - aPTT C

51 u Sometimes VERY - aPTT SP

52 Lot to Lot Reproducibility

53 Clinical Applications Operating Room –Cardiac Surgery –Interventional Cardiology and Radiology u Critical Care u Satellite Sites –Dialysis –ECMO –Emergency Room –Anticoagulation Clinic

54 Dialysis / ECMO u ACT (or nothing in dialysis) –Majority use P214 glass activated ACT –Some use ACT-LR; HemoTec u Better Control of Anticoagulation Leads 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

55 Emergency Room u ACT; aPTT; PT; Fibrinogen u Immediate Identification of Coagulopathies –Optimization of Critical Decision Pathways u ACT Allows Early Detection of Traumatic Coagulopathy –Allows Early Treatment Decisions –Aids Damage Control Decisions »Aucar, J. et.al SW Surgeons Congress u Optimize Staffing During Off Hours

56 Anticoagulation Clinics u Results Available While Patient is Present –Improved Anticoagulation Management –Improved Standard of Care –Staff Efficiency u Immediate Retesting (if needed) –Fingerstick Sampling u Same System for Clinic and Home Bound Patients –Standardized ISI / PT normal »Test System Specific

57 Anticoagulation Clinics u Potential for Self-Testing –High Risk Patients –Patients Who Travel Frequently –Home-Bound –Patients in Rural Areas Far from Clinic u Improved Outcomes Through More Frequent Testing

58 How to compare INR differences â Has the Hemostatic Balance been Upset? â Is the Clinical Response Different?

59 Must change dose Target INR 3.0 Range Must change dose Call Clinic May change dose Call Clinic Patient Management

60 Whats the catch? 1. Regulatory compliance 2. Connectivity

61 Regulatory compliance u Who sets the rules? –JCAHO »Joint Commission on Accreditation of Health Care Organizations –CAP »College of American Pathologists –FDA »Food and Drug Administration

62 CLIAC u CLIA Committee –Define and interpret CLIA regulations u CLIA - Clinical Laboratory Improvement Act –Designed to ensure accuracy of results from clinical laboratories –Compliance required to pass »JCAHO and / or CAP inspections –CLIA defines regulations for each test »CDC / FDA complexity categories

63 CLIA Applies to ALL Testing Areas u Central Laboratory u Satellite Labs –Critical Care –Surgical Suite u Clinics u Bedside testing u Doctors office

64 CLIA Regulations for Coagulation u Central Laboratory can hold the CLIA license –Satellites can have independent licensure u Moderately Complex tests –Except - ProTime and Coaguchek are waived u Requires –Certified Laboratory Director –Record Keeping –Training –Quality Policy

65 Implementing POC coag requires: RECORD KEEPING u Method Validation - accuracy –comparison to current standard u Linearity Assessment –Also used for ACT calibration/ verification –Is assay performance appropriate to clinical needs? –Does linear range span clinical range? u Training –competency evaluations at predetermined intervals

66 u Routine Quality Control –Instrument Performance Verification »Electronic Quality Control with Numeric Output »Two levels per 8 hour shift –Assay Performance Verification »Wet QC as per Manufacturers Recommendation »Two levels for each box of reagent when opened

67 Connectivity u Everyone wants it –Almost no one is ready to implement u Multiple definitions –Download to computer »To LIS or to HIS or to both or to data management software »Real time or batch »QC data, patient data, or both

68 Short term solutions u Interim programs for data capture, QC compliance tracking –transfer to file format easily adaptable »Requires independent transfer protocol »e.g., ITC ReportMaker u Dedicated interface specific to one manufacturers instrumentation »e.g., Abbott; Lifescan »Manufacturer ensures system compatibility

69 u Instrument manufacturer neutral interface –RALS-plus –Telcor –Manufacturer works with interface supplier to ensure compatibility –Interface supplier works with LIS / HIS supplier to ensure compatibility

70 Telcor concept Quick Serv (DM) LIS/HIS Quick Script or Quick EDI Quick Linc ITC Dawning box Data translation Via hospital Ethernet OR Cath lab CCU

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72 RALS plus concept LIS Results that meet user-defined criteria are transferred to the LIS for placement on the patients permanent medical record HIS RALS-ADT gathers demographic data to enable patient verification Test results are transferred from a RALS-Plus Test Station to the RALS-Plus Core System (RCS) Glucose ICU RALS Dataport Coagulation ER RALS Plus Test Station Glucose Urinalysis 9 West RALS Remote Connect Hospital Client PC POCCs can view, analyze, or edit results using the RALS-Plus IMS (Information Management System) RALS-IMS RALS-Core System (RCS) Located in the Hospital Data Center Coagulation Glucose Blood Gas

73 Long term Solutions u POC Connectivity Industry Consortium –Accepted as NCCLS document POCT1-A –sections of the CIC specification approved by: »IEEE »HL7 –Standardization of POC connectivity: »Messages »Protocols »Technologies

74 Why Bother with POC Coag? u Improved TAT - Turn Around Time –Defined from the Clinician, not Lab view –When is Turn Around Important »Emergency Room »ICU/CCU Dose Adjustments »Operating Room / Cath Lab –STAT Testing Turn Around

75 STAT Testing TAT Fitch, et.al, J. Clin Monit & Comput :

76 Standardized Clinical Interpretation u Defined Assay Sensitivity –Requires Lot to Lot Reproducibility u Defined Reagent Variability –Identical Instrumentation and Reagents at All Testing Sites u Defined Critical Clinical Decision Points –No Change of Normal Ranges or Target Times Between Lots of Test Reagents or Testing Locations

77 Why Bother with POC Coag? u Improved Clinical Outcome u Reduced LOS – Length of Stay u Improved, timely patient care


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