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OpenTrials
Completed

NCT Number: NCT02588976

Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform kaolin-based activated clotting time as routine monitor of heparin therapy in patients undergoing cardiac operations. In addition, the device allows the assessment of the patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has been developed. As part of the routine management using S1, tests are also performed on S2. Results are entered into the cardiac surgery data base of all cardiac surgery patients and analyzed.

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Key information

Conditions

Diagnostic Techniques and Procedures Cardiac Surgical Procedure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to routinely perform kaolin-based activated clotting time (kACT) as monitor of heparin therapy in patients undergoing cardiac operations on cardiopulmonary bypass.

Apart from kACT, the device allows the assessment of the patient's coagulation status by a glass-bead activated test (gbACT+, depicting also clot rate = CR and platelet function = PF). Recently, a new SONOCLOT analyzer (S2) has been developed. Although the S2 shares the technical fundamentals with the S1, the redesign of the device may result in performance changes of kACT and gbACT.

Routine management in cardiac surgery patients is guided using S1 and addition, tests are run on S2. Data are entered into the the cardiac surgery data base and S1 and S2 performance is compared by Bland-Altman analysis and % error calculation in order to establish new reference values.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consecutive cardiac surgery patients

Exclusion criteria

  • none

Treatment and study plan

Sonoclot Analyzer

Device

Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer

Primary outcomes

  1. Kaolin-activated Clotting Time

    Time frame: Routine measurements during cardiac surgery

Secondary outcomes

  1. Glass Bead Activated Clotting Time

    Time frame: Routine measurements during cardiac surgery

Sponsors and collaborators

Lead sponsor

Triemli Hospital

Other

Registry information

Acronym: SONEW

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 28, 2015
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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