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4-4     Chapter 4: Heparin Management in Cardiopulmonary Bypass Surgery

Pre Bypass: Baseline

Running a sample prior to heparin is useful to gain an 
understanding of the patient’s hemostasis performance.  
The recommended test is a glass bead activated 
differential heparinase panel.  One channel runs a 
glass bead activated test which is Sienco’s preferred  
reagent for comprehensive hemostasis evaluation; 
the other channel runs a heparin neutralized glass 
bead activated test.  The reason for running a heparin 
neutralized test is to ensure that the baseline test has 
not been compromised by some unexpected heparin 
contamination or pre-administration.  The Sonoclot 
Signatures above show a baseline with a small amount 
of unexpected heparin.

On Bypass: High Dose Heparin Therapy

High dose heparin management using the Sonoclot Analyzer’s ACT result is similar to using other ACT 
instruments.  The Sonoclot Analyzer also offers the added benefit of the Clot Rate result that quantifies 
how fast the clot develops after the ACT result has been calculated.  The objective of anticoagulant 
management is to prevent clot formation.  The Clot Rate result is a more direct measurement of heparin’s 
effect of clot formation.  Multiple researchers have found the Clot Rate result to be more specific to 
heparin concentration than the ACT.

One recommended approach for comprehensive heparin management is to establish both ACT and 
Clot Rate thresholds.  Additional heparin is administered when either the ACT is below an established 
threshold or the Clot Rate is above an established threshold.  Typically, Clot Rate results are below 6 
during high dose heparin therapy.

Post Bypass: Heparin Reversal and Hemostasis Restoration

There are two coagulation concerns after bypass: adequate heparin reversal and overall hemostasis 
performance.

Since  both  residual  heparin  and  coagulation  factor  deficiencies  may  be  detected  after  protamine 
administration, running two tests, one with and one without heparin neutralization, provides comprehensive 
and specific results to characterize overall hemostasis performance.

In this post protamine example, the gbACT+ test showed 
a prolonged ACT and reduced Clot Rate.  These results 
could indicate either residual heparin or inadequate 
coagulation factors.  The heparin neutralized version 
of the gbACT+ test showed normal results for the 
ACT and Clot Rate.  The heparin neutralized test also 
showed normal clot retraction.  The amount of residual 
heparin in this example can easily be missed with a 
standard ACT.

Patient 2 Pre

Minutes

0.0

5.0

10.0

15.0

20.0

25.0

30.0

Clot

Signal

0

25

50

75

100

125

Group Description

Style Time Patient Test Application Operator Result Range

Heparin Neutralized

Control

glass bead activated tests

Patient 2 Post

Minutes

0.0

5.0

10.0

15.0

20.0

25.0

30.0

Clot

Signal

0

25

50

75

100

125

Group Description

Style Time Test Application Result Range Comment

Control

Heparin Neutralized

glass bead activated tests

Summary of Contents for Sonoclot

Page 1: ...t Analyzer User Guide for Cardiopulmonary Bypass Surgery Rev 1 0 Sienco Inc 5721 Arapahoe Ave Unit A1 A Boulder CO 80303 USA 303 420 1148 1 800 432 1624 Fax 303 379 4403 www sienco com e mail sienco sienco com ...

Page 2: ... Sienco Inc 5721 Arapahoe Ave Unit A1 A Boulder CO 80303 USA 1 303 420 1148 1 303 379 4403 FAX sienco sienco com e mail http www sienco com Sonoclot is a registered trademark of Sienco Inc Sonoclot Analyzers are protected under U S and foreign patents ...

Page 3: ...clot Analyzer Principle of Operation 3 1 Sonoclot Signature 3 1 Sonoclot Analyzer Quantitative Outputs 3 2 Sonoclot Signature Phases 3 2 Chapter 4 Heparin Management in Cardiopulmonary Bypass Surgery 4 1 Heparin 4 1 Heparin Effects on Coagulation 4 1 Heparin Management Objectives 4 2 Activation Reagents for Heparin Monitoring 4 2 Pre Bypass Baseline 4 4 On Bypass High Dose Heparin Therapy 4 4 Post...

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Page 5: ...diopulmonary bypass surgery Hemostasis Management Testing Needs Cardiopulmonary bypass surgery teams need to manage heparin administration neutralize heparin and resolve bleeding complications The specific requirements for hemostasis management throughout cardiopulmonary bypass surgery may include pre surgical screening for potential existing coagulopathies verification of adequate anticoagulant t...

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Page 7: ...ot The Coagulation Cascade Traditionally this process has been explained with a cascade hypothesis Over years of research this coagulation hypothesis has been revised and expanded however it still provides a foundation for most coagulation testing including prothrombin time PT activated partial thromboplastin time aPTT thrombin time TT and activated clotting time ACT The coagulation cascade hypoth...

Page 8: ...on continues in the propagation phase of the model Fibrin formation occurs when thrombin is present The rate of fibrin formation is initially zero until the beginning of the amplification phase The rate of fibrin formation increases during the amplification phase During propagation thrombin formation sustains fibrin formation until the available fibrinogen is converted into fibrin Initiation Ampli...

Page 9: ...hese fibrin strands link together into a gel The platelets adhere to multiple nodes of the fibrin gel and cause the gel to collapse together or retract Fibrinolysis Eventually fibrin clots dissolve through the activation of the fibrinolytic system The activated enzyme plasmin is formed from plasminogen and breaks fibrin strands into smaller fibrin split products The fibrin split products do not po...

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Page 11: ... test sample The greater the viscosity of the fluid the greater the output signal generated by the analyzer The output signal is calibrated to reference viscosity standards and reported in normalized Clot Signal units Sonoclot Signature The viscoelastic measurement changes over time as the clot forms and evolves The series of Clot Signal measurements throughout the test analysis is referred to as ...

Page 12: ...ation Reaction Phase This first phase is the period from the beginning of the test when the sample is still a liquid until the point when fibrinogen begins to convert into a fibrin gel thus increasing the viscosity of the sample The Sonoclot Analyzer produces an automated result the Activated Clotting Time ACT This result is the time when the viscosity measurement rises by 1 0 Clot Signal units on...

Page 13: ...noclot Signature Different researchers used different techniques and terms for quantifying clot retraction Some of those terms include Time to Peak R2 Peak Angle Upslope or Downslope While some of these terms generated useful results the range of shapes of Sonoclot Signatures resulted in problems with consistent interpretation between users The quantitative Platelet Function result provides an aut...

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Page 15: ...hown here This heparin dose response run using kaolin activation with Sienco s kACT test shows the same blood sample run with different heparin concentrations The ACT result increases approximately linearly with increasing heparin concentration The ACT result generated with the kACT is intended for high dose heparin management Important ACT results among various instruments or activation formulati...

Page 16: ...entrations heparin must be re administrated periodically during cardiovascular bypass surgery Accurate heparin dosing requires heparin monitoring to guide heparin re administration Activation Reagents for Heparin Monitoring Any coagulation test is a combination of many separate processes including collecting a blood sample activating the blood sample and analyzing the blood sample The specific act...

Page 17: ...30 35 0 1 2 3 4 5 Clot Rate versus Heparin Concentration Clot Rate Clot Signal minutes Heparin Concentration IU mL whole blood 0 5 10 15 20 25 0 0 2 0 4 0 6 0 8 Clot Rate versus Heparin Concentration Clot Rate Clot Signal minutes Heparin Concentration IU mL whole blood gbACT 0 5 10 15 20 25 30 35 0 1 2 3 4 Clot Rate versus Heparin Conc Clot Rate Clot Signal minutes Heparin Concentration IU mL w kA...

Page 18: ...in management is to establish both ACT and Clot Rate thresholds Additional heparin is administered when either the ACT is below an established threshold or the Clot Rate is above an established threshold Typically Clot Rate results are below 6 during high dose heparin therapy Post Bypass Heparin Reversal and Hemostasis Restoration There are two coagulation concerns after bypass adequate heparin re...

Page 19: ...lot retraction Low platelet function results provide a useful indicator to help guide platelet blood component therapy Important useful platelet function results require that a fibrin clot forms Heparin inadequate coagulation factors or low fibrinogen can all contribute to impaired clot retraction In order to properly identify poor platelet function first ensure that the Sonoclot Signature or ACT ...

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Page 21: ...ation measurement with Sonoclot predicts postoperative bleeding in cardiac surgery after heparin reversal J Cardiothorac Vasc Anesth 2015 Jan 29 3 715 722 YamadaT Katori N Tanaka KA Takeda J Impact of Sonoclot hemostasis analysis after cardiopulmonary bypass on postoperative hemorrhage in cardiac surgery J Anesth 2007 21 2 148 52 Ganter MT MonnA Tavakoli R Klaghofer R ZollingerA Hofer CK Kaolin ba...

Page 22: ...nitoring fondaprinux with the Sonoclot Blood Coagulation and Fibrinolysis 2007 18 619 622 Tucci MA Ganter MT Hamiel CR Klaghofer R Zollinger A Hofer CK Platelet function monitoring with the Sonoclot analyzer after in vitro tirofiban and heparin administration J Thorac Cardiovasc Surg 2006 Jun 131 6 1314 22 Cell Based Model of Coagulation Smith SA The cell based model of coagulation J ofVeterinary ...

Page 23: ... then emailing the exported file to support sienco com or your distributor Instructions for exporting data from Signature Viewer are provided below Exporting Signature Groups from Signature Viewer 1 Select the Signature Group that you wish to export Under the File Menu select Export Signature Group An Export Dialog Box will open 2 In the Export Dialog you need to enter the filename for the exporte...

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