Sienco Sonoclot User Manual

Sonoclot Analyzer

User Guide

for Cardiopulmonary Bypass Surgery

Rev 1.0

5721 Arapahoe Ave, Unit A1-A, Boulder, CO 80303 USA

303-420-1148 1-800-432-1624 Fax [phone]

www.sienco.com e-mail: [e-mail]

Sienco, Inc.

Copyright © 2012-2016 Sienco®, Inc. All Rights Reserved.

Sienco®, Inc.
5721 Arapahoe Ave, Unit A1-A, Boulder CO 80303 USA
1-303-420-1148 1-303-379-4403 (FAX)
[e-mail] (e-mail)
http://www.sienco.com

Sonoclot is a registered trademark of Sienco®, Inc.

Sonoclot Analyzers are protected under U.S. and foreign patents.

Table of Contents

Chapter 1: Hemostasis and Why We Care About It in Cardiopulmonary Bypass Surgery 1-1

Overview 1-1
Hemostasis Management Testing Needs 1-1
Hemostasis Management and the Sonoclot Analyzer 1-1

Chapter 2: Hemostasis Fundamentals 2-1

Hemostasis Basics 2-1
Fibrin Gel Formation 2-3
Clot Retraction, i.e. Platelet Function 2-3
Fibrinolysis 2-3

Chapter 3: Evaluating Global Hemostasis with the Sonoclot Analyzer 3-1

The Sonoclot 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 Bypass: Heparin Reversal and Hemostasis Restoration 4-4
Platelet Function 4-5

Chapter 5: References and Further Reading 5-1

Chapter 6: Technical Support 6-1

Contact Information 6-1
Exporting Signature Groups from Signature Viewer 6-1

Chapter 1:

Hemostasis and Why We Care About It in

Cardiopulmonary Bypass Surgery

Overview

Cardiopulmonary bypass surgery degrades hemostasis. There are multiple contributing factors to this
degradation. Heparin is added to inhibit coagulation; blood volume is diluted; coagulation factors and
platelets are activated by bypass circuits and surgical trauma; heparin is reversed with protamine restoring
coagulation; and bleeding depletes clotting factors and platelets.

During bypass, inadequate anticoagulation elevates thrombotic risks. Excessive anticoagulation potentially
impairs hemostasis restoration. Accurate anticoagulation management reduces both thrombotic risk
during bypass and potential bleeding complications after bypass.

Post bypass, hemostasis may be impaired by loss of clotting factors or platelets, residual heparin, or
excessive uncorrected vascular damage. Blood component therapy may be necessary to control bleeding,
but unnecessary use of blood products should be avoided.

Hemostasis performance and clinical management affect patient outcomes and treatment costs. Effective
and comprehensive hemostasis management is one important component of cardiopulmonary bypass
surgery.

Hemostasis Management Testing Needs

Cardiopulmonary bypass surgery teams need to manage heparin administration, neutralize heparin,

and resolve bleeding complications. The specic requirements for hemostasis management throughout

cardiopulmonary bypass surgery may include: pre-surgical screening for potential existing coagulopathies,

verication of adequate anticoagulant therapy prior to bypass, management of anticoagulant therapy

during bypass, and comprehensive hemostasis assessment post bypass and throughout recovery.

Technology trends are moving more advanced instruments into the operating room offering comprehensive
test results of coagulation assessment, platelet function, and overall hemostasis performance with point­of-care convenience.

Hemostasis Management and the Sonoclot Analyzer

The Sonoclot Analyzer is a sensitive instrument designed to detect and quantify viscoelastic changes in a
whole blood sample that occur throughout hemostasis. Hemostasis testing with the Sonoclot Analyzer has
evolved to address multiple needs of cardiopulmonary bypass surgery including both anticoagulation and
bleeding management. The Sonoclot Analyzer product line is the only integrated solution that addresses
both convenient and cost effective anticoagulation management with global hemostasis monitoring for
managing clinical bleeding.

1-1

Chapter 2:

Hemostasis Fundamentals

Blood has the biomechanical ability to change from a liquid into a brin clot, further evolve into a mature
clot, and nally dissolve back into a liquid. These physiological processes encompass not just coagulation

but also other aspects of overall hemostasis including platelet activation, clot retraction, and lysis. Any
weak link in this coagulation and hemostasis sequential process can result in bleeding complications or
elevated risk of thrombosis.

Hemostasis Basics

The coagulation process addresses the reactions occurring in blood or plasma that precede and initiate

the formation of of brin clot.

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 hypothesis denes three pathways leading to initial brin formation: the

intrinsic, extrinsic, and common pathways. The intrinsic and extrinsic pathways merge into the
common pathway when factor X becomes activated Xa.

Contact Activator

XII

XIIa

XI

XIa

IX

Intrinsic Pathway

IXa

VIII

X

Prothrombin

Extrinsic Pathway

Tissue Factor

VII

Xa

Common Pathway

V

Thrombin

X

Fibrinogen

Fibrin

2-1