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Sienco Sonoclot User Manual

Analyzer for cardiopulmonary bypass surgery
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Sonoclot 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

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Summary of Contents for Sienco Sonoclot

  • Page 1 Sonoclot 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 , 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) 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: Table Of Contents

    Chapter 2: Hemostasis Fundamentals Hemostasis Basics Fibrin Gel Formation Clot Retraction, i.e. Platelet Function Fibrinolysis Chapter 3: Evaluating Global Hemostasis with the Sonoclot Analyzer The Sonoclot Analyzer Principle of Operation Sonoclot Signature Sonoclot Analyzer Quantitative Outputs Sonoclot Signature Phases Chapter 4: Heparin Management in Cardiopulmonary Bypass Surgery...

  • Page 5: Chapter 1: Hemostasis And Why We Care About It In Cardiopulmonary Bypass Surgery

    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.

  • Page 7: Chapter 2: Hemostasis Fundamentals

    Chapter 2: Hemostasis Fundamentals Blood has the biomechanical ability to change from a liquid into a fibrin clot, further evolve into a mature clot, and finally 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.
  • Page 8 Amplification Initiation Propagation Activator Initial Thrombin Generation Thrombin Formation Accelerators Initial Thrombin Generation Thrombin Formation Accelerators Mass Thrombin Generation (Initial Clot Formation: Sonoclot ACT) (Sustained Rate of Fibrin Formation: Sonoclot ClotRate) Activator Activator XIIa XIIa VIIIa VIII Prothrombin (II)

  • Page 9: Fibrin Gel Formation

    Fibrin Gel Formation Fibrin formation begins with fibrinogen converting into fibrin monomers. The fibrin monomers spontaneously polymerize into a fibrin gel. Gel formation is affected by the rate of thrombin formation, the rate of thrombin neutralization, and the amount of fibrinogen. Clot Retraction, i.e.

  • Page 11: Chapter 3: Evaluating Global Hemostasis With The Sonoclot Analyzer

    Evaluating Global Hemostasis with the Sonoclot Analyzer The Sonoclot Analyzer is an advanced global hemostasis analyzer. As a point-of-care device, it is used in operating rooms and cardiovascular intensive care units to assess hemostasis performance before, during, and after cardiopulmonary bypass surgery. The Sonoclot Analyzer provides accurate information on the entire hemostasis process including coagulation, fibrin formation, clot retraction, and hyperfibrinolysis (when present).

  • Page 12: Sonoclot Analyzer Quantitative Outputs

    Sonoclot Signature Phases In each test run on the Sonoclot Analyzer, a reagent is added to a whole blood sample that initiates the clot formation process. The resulting Sonoclot Signature can be divided into separate phases that relate to specific aspects of hemostasis performance.
  • Page 13 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 automated and convenient result for characterizing clot retraction within a test sample.

  • Page 15: Chapter 4: Heparin Management In Cardiopulmonary Bypass Surgery

    Coagulation Reaction Phase, increasing the ACT result, and prolong the Clot Formation Phase, decreasing the Clot Rate. A heparin dose response on the Sonoclot Signature is shown here. This heparin dose response, run using kaolin activation with Sienco’s kACT test, shows the same blood sample run with different heparin concentrations.

  • Page 16: Heparin Management Objectives

    The Sonoclot Analyzer is a superior instrument for managing heparin because it characterizes both the coagulation reaction time typical of ACT instruments and additionally characterizes the development of the actual clot.
  • Page 17 Clot Clot Signal Signal 10.0 15.0 20.0 Here are heparin dose response Signatures run using kaolin (kACT) and glass beads (gbACT+). Minutes Sonoclot Signature versus Style Time Test Application Result Range Comment Heparin-gbACT+ Heparin-kACT Heparin Concentration 10.0 15.0 10.0 15.0 20.0...

  • Page 18: Pre Bypass: Baseline

    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.

  • Page 19: Platelet Function

    The result of reducing platelet function by inhibiting platelets attenuates and finally eliminates clot Integrilin 2 retraction. The Sonoclot Signatures get flatter and flatter after the fibrin clot forms. Note that the effect Group Description of inhibiting platelets does not affect either the Coagulation Reaction Phase (ACT) or the Clot Formation Integrilin Phase (Clot Rate).
  • Page 21 Sonoclot Analysis is used in many clinical and research applications and consequently is referenced in numerous studies and articles. Following is a list of publications discussing the use of the Sonoclot Analyzer in cardiovascular surgery. For a complete list of references, please visit www.sienco.com.

  • Page 22: Chapter 5: References And Further Reading

    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.

  • Page 23: Chapter 6: Technical Support

    Sonoclot Signatures through our technical staff or our local distributors. Signature Viewer, Sienco’s data collection program for the Sonoclot Analyzer, can be used to share your Sonoclot Signatures for interpretive assistance or confirmation. You can send Signatures by first organizing the Signatures of interest into a Signature Group, next exporting the Signature Group from Signature Viewer, and then emailing the exported file to support@sienco.com or your distributor.

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