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

NCT ID: NCT02588976

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diagnostic Techniques and Procedures; Cardiac Surgical Procedure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ACT measurements

ACT measurements by SONOCLOT Analyzer during cardiac surgery

Group Type: OTHER

Sonoclot Analyzer

Intervention Type: DEVICE

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

Interventions

Sonoclot Analyzer

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• all consecutive cardiac surgery patients

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triemli Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christoph K Hofer

Prof. Dr. med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Genoni, MD

Role: STUDY_CHAIR

Triemli City Hospital

References

Ganter MT, Hofer CK. Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg. 2008 May;106(5):1366-75. doi: 10.1213/ane.0b013e318168b367.

Reference Type: BACKGROUND

PMID: 18420846 (View on PubMed)

Other Identifiers

STZ-Dendrite06

Identifier Type: -

Identifier Source: org_study_id