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What is it? Why do we need it POC?

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Presentation on theme: "What is it? Why do we need it POC?"— Presentation transcript:

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

2 Coagulation Testing Monitoring hemostasis Bleeding Clotting

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

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

5 Coagulation is Complex

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

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

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

9 POC Coag Analyzers Differ
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 Critical Care Satellite Sites Dialysis ECMO Emergency Room Anticoagulation Clinic

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

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

13 Why are there so many different ACTs?

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

15 Monitoring - ACT 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, AmSECT meeting 17

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

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

19 Pharmaceutical Intervention
Aprotinin Significant elevation of celite ACT Two dosing regimens Full Hammersmith 2 x 106 KIU loading dose; 2 x 106 KIU pump prime; x 106 KIU/hr infusion Half Hammersmith 1 x 106 KIU loading dose; 1 x 106 KIU pump prime; x 106 KIU/hr infusion

20 ACT Monitoring-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+ 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
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 TT Intrinsic Pathway Extrinsic Pathway Common Pathway

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

26 Other POC Coag in the OR 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
Reduced Blood Loss/Transfusion Use of HRT and PRT (RxDx System) Jobes, D. et. al., J.Thorac.Cardiovasc.Surg. 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
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, 1997, NACB Presentation, Phila.

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

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

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

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

33 Why use platelet inhibitors?

34 Angioplasty promotes aggregation


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

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

38 ACT or aPTT 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 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 Poster at AACC 2000 – Staikos,

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

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

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

43 Heparin versus Warfarin

44 Prothrombin Time PT Intrinsic Pathway Extrinsic Pathway Common Pathway

45 Prothrombin Time Monitor warfarin therapy
Monitor heparin/warfarin crossover 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?
NO! (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?
Sometimes no - aPTT C

51 Sometimes VERY - aPTT SP

52 Lot to Lot Reproducibility

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

54 Dialysis / ECMO ACT (or nothing in dialysis)
Majority use P214 glass activated ACT Some use ACT-LR; HemoTec Better Control of Anticoagulation Leads to Increased Dialyzer Reuse Potential for Long Term Cost Savings No Compromise in Dialysis Efficacy (Kt/V) Ouseph, R. Am J Kidney Dis 35:89-94; 2000

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

56 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 / PT normal Test System Specific

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

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

59 Patient Management 6.0 5.0 4.0 3.0 2.0 1.0 Target INR 3.0
Must change dose Target INR 3.0 Range Call Clinic May change dose Patient Management

60 What’s the catch? Regulatory compliance Connectivity

61 Regulatory compliance
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 CLIA Committee CLIA - Clinical Laboratory Improvement Act
Define and interpret CLIA regulations 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
Central Laboratory Satellite Labs Critical Care Surgical Suite Clinics Bedside testing Doctor’s office

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

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

66 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 Manufacturer’s Recommendation Two levels for each box of reagent when opened

67 Connectivity Everyone wants it Multiple definitions
Almost no one is ready to implement 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 Interim programs for data capture, QC compliance tracking transfer to file format easily adaptable Requires independent transfer protocol e.g., ITC ReportMaker Dedicated interface specific to one manufacturer’s instrumentation e.g., Abbott; Lifescan Manufacturer ensures system compatibility

69 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 Quick Script or Quick EDI
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


72 RALS plus concept RALS-Core System (RCS) RALS-IMS LIS HIS Glucose ICU
Results that meet user-defined criteria are transferred to the LIS for placement on the patient’s 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 Urinalysis 9 West RALS Remote Connect Hospital Client PC POCC’s 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 Blood Gas

73 Long term Solutions 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?
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,, J. Clin Monit & Comput :

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

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

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