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

T

Triemli Hospital

Status

Completed

Conditions

Diagnostic Techniques and Procedures
Cardiac Surgical Procedure

Treatments

Device: Sonoclot Analyzer

Study type

Interventional

Funder types

Other

Identifiers

NCT02588976
STZ-Dendrite06

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all consecutive cardiac surgery patients

Exclusion criteria

  • none

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

ACT measurements
Other group
Description:
ACT measurements by SONOCLOT Analyzer during cardiac surgery
Treatment:
Device: Sonoclot Analyzer

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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