Diagnostic Techniques and ProceduresSONEWNCT02588976
Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
A study testing Sonoclot Analyzer in people with Diagnostic Techniques and Procedures and Cardiac Surgical Procedure, run by Triemli Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnostic Techniques and Procedures, Cardiac Surgical Procedure
- What is being tested?
- Sonoclot Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jan 2011
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive cardiac surgery patients
Who cannot join
- none
About this study
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.
Read the 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.
- Being tested
- Sonoclot Analyzer
- Keywords
- Activated clotting time, Sonoclot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonoclot AnalyzerDevice
Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer
| Study group | Role | What they receive |
|---|---|---|
| ACT measurements | Other | ACT measurements by SONOCLOT Analyzer during cardiac surgery Receives: Device: Sonoclot Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaolin-activated Clotting Time
Measured: Routine measurements during cardiac surgery
Secondary outcomes (1)
Glass Bead Activated Clotting Time
Measured: Routine measurements during cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Techniques and ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph K Hofer, Triemli Hospital
- Investigators
- Michele Genoni, MD, Study chair, Triemli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588976
- Sponsor's protocol ID
- STZ-Dendrite06
- Acronym
- SONEW
- Status last verified
- Apr 2018
- First submitted
- 23 Oct 2015
- Last updated
- 4 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18420846