coagulation testing what is it? why do we need it poc? itc educational services, edison, nj marcia...
TRANSCRIPT
![Page 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](https://reader033.vdocuments.net/reader033/viewer/2022051819/55148732550346d36e8b4cda/html5/thumbnails/1.jpg)
Coagulation TestingWhat 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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Coagulation Testing
Monitoring hemostasis
Bleeding Clotting
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Coagulation Testing Monitoring therapy
Intrinsic PathwayExtrinsic Pathway
Common Pathway
CLOT
Heparin CoumadinMonitor with
ACT / aPTT Monitor with PT
Thrombolytics Monitor with
TT / Fibrinogen
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Coagulation is ComplexPlatelet Adhesion
•shape change • release
ADP release
PlateletAggregation
Coagulation
•Fibrin formation
3 sec
10 sec
5 min
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Coagulation is Complex
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Common(?) Coagulation Tests Laboratory
PT..
aPTT
TT..
Fib.– Anti Xa– Anti IIa– Factor Assays
Point of Care
– ACT» Celite®
» Kaolin» Glass beads» Silica» thromboplastin
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Differences in test methods
Point of Care– Whole Blood
– No Added Anticoagulant
– No Dilution
– No Preanalytical Delay
Standard Laboratory– Platelet Poor Plasma
– Sodium Citrate Anticoagulant
– 1:9 Dilution
– Variable Preanalytical Delay
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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
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POC Coag Analyzers Differ
Test methodology– Sample size and application
– Sample measurement
– Clot detection method» Enzyme detection method
– Reagent composition
– Results
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Clinical ApplicationsOperating Room
– Cardiac Surgery– Interventional Cardiology and Radiology
Critical Care Satellite Sites
– Dialysis– ECMO– Emergency Room– Anticoagulation Clinic
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Activated Clotting Time
Intrinsic Pathway
Extrinsic Pathway
Common Pathway
CLOT
ACT
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What do we use an ACT for? Maintain Balance
– Bleeding Thrombosis Heparin
– Rapid Anticoagulant Effect» Individual sensitivities vary significantly» Potency differences
Source: Bovine or Porcine Lot to Lot variability
– Rapidly Reversible with Protamine
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Why are there so many different ACTs?
0
100
200
300
400
500
600
700
0 1 2 3 4 5
Heparin (units/ml)
Clo
ttin
g T
ime
(sec
)
C-ACT
K-ACT
ACT+
P214
ACT-LR
CCUDialysis
CATHPTCA CPB
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Monitoring - ACT
Benefits– Industry Standard Since 1970s– Recommended as primary method
in AmSECT guidelines (perfusion)– Easy to run
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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
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475
500
525
550
575
600
625
650
675
700
PreCPB
15min
30min
45min
60min
75min
90min
105min
Seco
nds
Hemochron
Hemotec
TAS
HMS
Heparinized ACT - CPB
Data from Huffman, et.al. 1998 AmSECT meeting
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Monitoring in CPB - ACT
Data from clinical evaluation, on file, ITC
0
100
200
300
400
500
600
700
800
900
1000
Clo
ttin
g T
ime
Kaolin ACT
Celite ACT
ACT+
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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
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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; 0.5 x 106 KIU/hr infusion
» Half Hammersmith 1 x 106 KIU loading dose; 1 x 106 KIU pump prime;
0.25 x 106 KIU/hr infusion
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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
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ACT Monitoring -Aprotinin Treatment
0
200
400
600
800
1000
1200
Baseline PostBolus PostBolus2 OnPump OnPump2 OnPump3 PostProt.
Clo
ttin
g T
ime
.
Kaolin ACT
Celite ACT
ACT+
Data from clinical evaluation, on file, ITC
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Alternative Monitoring - Aprotinin HiTT - High Dose Thrombin Time
Control Patients
0
200
400
600
800
1000
Baseline Post-Bolus CPB 1 CPB 2 Post-Protamine
Clot
ting
Tim
e
Celite
Kaolin
HiTT
Aprotinin Patients
0
200
400
600
800
1000
Baseline Post-Bolus CPB 1 CPB 2 Post-Protamine
Clot
ting
Tim
e
Celite
Kaolin
HiTT
Adapted from Huyzen, et. al. J.CardioThorac. Vasc. Anesth. 8:153, 1994
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Alternative Monitoring - Aprotinin
Kaolin ACT
0
200
400
600
800
1000
Baseline Post-Bolus CPB 1 CPB 2 Post-Protamine
Clot
ting
Tim
e
Aprotinin
Placebo
HiTT
0
50
100
150
200
250
Baseline Post-Bolus CPB 1 CPB 2 Post-Protamine
Clot
ting T
ime
Aprotinin
Placebo
Adapted from Huyzen, et. al. J.CardioThorac.Vasc.Anesth. 8:153, 1994
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Thrombin Time
Intrinsic Pathway
Extrinsic Pathway
Common Pathway
CLOTTT
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Other POC Coag in the OR aPTT / PT
– Pre- and post-procedural screening Fibrinogen
– Pre- and post-procedural screening Dosing Assays
– Customize heparin and protamine for each patient» HEMOCHRON HRT / PRT» Hepcon HMS» RapidPoint
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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
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Outcome studies - POC in OR 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, D. et. al., 1996. Am Soc Anesth Mtg.
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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, et.al. 1997, NACB Presentation, Phila.
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Clinical ApplicationsOperating Room
– Cardiac Surgery– Interventional Cardiology and Radiology
Critical Care Satellite Sites
– Dialysis– ECMO– Emergency Room– Anticoagulation Clinic
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Procedures Diagnostic
– Catheterization» locate and map vessel blockage(s)» determine need for interventional procedures
– Electrophysiology Interventional
– Balloon angioplasty
– Arthrectomy (roto-rooter)
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Diagnostic – Low dose heparin
Catheterization and Electrophysiology– 2500 - 5000 unit bolus dose
– frequently not monitored
– if monitored – » ACT» aPTT
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Interventional – Moderate dose
Angioplasty and Arthrectomy– 10,000 unit bolus dose or
– 2 - 2.5 mg/kg
– target ACT 300 - 350 seconds » unless platelet inhibitors used
200 – 300 in presence of ReoPro
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Why use platelet inhibitors?
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Angioplasty promotes aggregation
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Platelet Inhibitors ReoPro
– elevates ACTs
– target time = 250 sec with ReoPro» determined using FTCA510 tube
Integrelin– No reported effects on ACT
Aggrastat– No reported effects on ACT
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Clinical ApplicationsOperating Room
– Cardiac Surgery– Interventional Cardiology and Radiology
Critical Care Satellite Sites
– Dialysis– ECMO– Emergency Room– Anticoagulation Clinic
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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
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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, et.al.
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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
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Activated Partial Thromboplastin Time
Intrinsic Pathway
Extrinsic Pathway
Common Pathway
CLOT
APTT
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NOT a PTT– PTT is the predecessor of the aPTT– Not used anymore
Laboratory or Point of Care High APTT values
1. the presence of heparin
2. underlying coagulopathy Monitor heparin / coumadin® cross-over
Activated Partial Thromboplastin Time
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Heparin versus Warfarin
Drug ActionMechan-
ismMoni-toring
Effective
HeparinDirect
Inhibition ofThrombin
ATIIIcofactor
APTTACT
Immediate
WarfarinDecreasesProductionof factors
Vitamin K PTDelay
3-5 days
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Prothrombin Time
Intrinsic Pathway
Extrinsic Pathway
Common Pathway
CLOT
PT
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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= 2.0 - 3.0
» artificial heart valve: INR=3.0 - 4.0
ISI
meannormal
patient
PT
PTINR
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Will POC Results Match the Lab?
(Probably Not)
but it WILL Correlate
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Correlate Does Not Mean Match
y = 0.737x + 22.2R = 0.920
0
20
40
60
80
100
120
140
0 50 100 150Lab APTT
Sig
na
ture
AP
TT
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Coag is NOT Chemistry
y = 0.4493x + 17.898y = 0.4723x + 20.24y = 0.4374x + 22.173
IL C
Dade Actin / MLA
y = 0.72x + 11.5R = 0.883
20
30
40
50
60
70
20 30 40 50 60 70lab
Sig
na
ture
IL aPTT SP / ACL #2
y = 0.59x + 16.0R = 0.961
10.0
30.050.0
70.090.0
110.0130.0
150.0
10 30 50 70 90 110 130 150lab
Sig
na
ture
IL aPTT C / ACL #3y = 0.44x + 22.2
R = 0.9533
10.0
30.050.0
70.090.0
110.0130.0
150.0
10 30 50 70 90 110 130 150lab
Sig
na
ture
Organon Technika / MDA
y = 1.02x + 4.1R = 0.942
20
30
40
50
60
70
20 30 40 50 60 70lab
Sig
na
ture
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y = 0.4493x + 17.898y = 0.4723x + 20.24y = 0.4374x + 22.173
IL C
IL SP
IL aPTT C /ACL #1
y = 0.45x + 17.9R = 0.929
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
IL aPTT SP / ACL #1
y = 0.35x + 22.1R = 0.928
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
IL aPTT C / ACL #2
y = 0.47x + 20.2R = 0.942
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
IL aPTT SP / ACL #3
y = 0.40x + 23.3R = 0.912
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
IL aPTT C / ACL #3
y = 0.44x + 22.2R = 0.953
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
IL aPTT SP / ACL #2
y = 0.59x + 16.0R = 0.961
0.0
20.0
40.0
60.0
80.0
100.0
0 50 100 150lab
Sig
na
ture
Compare for your site.
Same System / Multiple Sites
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Are differences important?
Sometimes no - aPTT C
Signature site 1 site 2 site 330 27 21 1840 49 42 4150 71 63 6460 94 84 8770 116 105 10980 138 127 13290 160 148 155
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Sometimes VERY - aPTT SPSignature site 1 site 2 site 3
30 23 24 3340 51 41 8250 80 57 13060 109 74 17970 138 91 >20080 167 108 >20090 196 125 >200
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Lot to Lot ReproducibilitySignature
30405060708090
Cuvette Lot a
y = 1.35x - 14.2R=.909
20
30
40
50
60
70
80
20 40 60 80Signature
La
b
Cuvette Lot b
y = 1.39x - 12.8R=0.934
20
30
40
50
60
70
80
20 40 60 80Signature
La
b
Signature Lot a Lot b30 26 2940 40 4350 53 5760 67 7070 80 8480 93 9890 107 112
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Clinical ApplicationsOperating Room
– Cardiac Surgery– Interventional Cardiology and Radiology
Critical Care Satellite Sites
– Dialysis– ECMO– Emergency Room– Anticoagulation Clinic
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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. et.al. Am J Kidney Dis 35:89-94; 2000
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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. et.al. 1998 SW Surgeons Congress
Optimize Staffing During Off Hours
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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
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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
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How to compare INR differences
Has the Hemostatic Balance been Upset? Is the Clinical Response Different?
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6.0
5.0
4.0
3.0
2.0
1.0
Must change dose
Target INR 3.0Range 2.5 -3.5
Must change dose
Call Clinic
May change dose
May change dose
Call Clinic
Patient Management
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What’s the catch?
1. Regulatory compliance
2. Connectivity
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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
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CLIAC CLIA Committee
– 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
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CLIA Applies to ALL Testing Areas
Central Laboratory Satellite Labs
– Critical Care
– Surgical Suite Clinics Bedside testing Doctor’s office
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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
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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
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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
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Connectivity
Everyone wants it– 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
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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
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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
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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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Quick-Multi-Linc (QML)
Blood Gas
Co-ox
Coagulation
Glucose
Chemistry
I M P O R T
Snapshot
Exception Management
Quality Control
Operator Management
Device Management
Statistics
Manual Result Entry
Configuration
Result Management
Windows 2000 SP1 Workstation
Data Management Configuration
Output Management
Quick-Script
Quick-EDI
or
Interface Management
LIS / HIS Host
System
POC
Vend
or’s
Dat
a
Com
mun
icat
ion
& Se
t-U
p
Output
Cardiac Marker
Urinalysis
Terminal Emulation
Host EDI
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RALS plus concept
LIS
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
TM
MAS
RALS DATA PO RT®
Coagulation
ERRALS Plus Test
Station
Glucose
Urinalysis
9 WestRALS Remote
ConnectHospital 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
Coagulation Coagulation
Glucose
Blood Gas
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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
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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
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STAT Testing TAT
Lab (min) Median
CPB (N=40)90.0
PVS (N=45)90.0
Mean 78.5 74.0Minimum 38.0 21.0
POC (min)Median
All Groups2.23
Minimum 0.33Maximum 6.97
Fitch, et.al, J. Clin Monit & Comput. 1999. 15:197-204
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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
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Why Bother with POC Coag?
Improved Clinical Outcome Reduced LOS – Length of Stay Improved, timely patient care