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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02588976
- Acronym / sponsor ID
- SONEW / STZ-Dendrite06
- Keywords
- Activated clotting time, Sonoclot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT measurements | Other | Device: Sonoclot AnalyzerACT measurements by SONOCLOT Analyzer during cardiac surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive cardiac surgery patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonoclot AnalyzerBlood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer | Device | ACT measurements |
Primary outcome
Kaolin-activated Clotting Time
Time frame: Routine measurements during cardiac surgery
1 secondary outcome
Glass Bead Activated Clotting Time
Time frame: Routine measurements during cardiac surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18420846Ganter 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.
- Individual participant dataSharing planned: No
Related trials for Diagnostic Techniques and Procedures
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruitingObservational study
Development and Evaluation of Techniques for Computer Aided Detection and Diagnosis From Existing Radiologic Images
Radiology Information Systems
RecruitingObservational study
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings
COPD (Chronic Obstructive Pulmonary Disease), Airway Disease
Not yet recruiting
Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary
Advanced Unspecific Symptom, Cancer of Unknown Primary Site
Active, not recruitingObservational study
The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals
Urinary Tract Infections, Diagnostic Techniques and Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Genoni, MD study chair
Triemli City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sonoclot Analyzer in people with Diagnostic Techniques and Procedures and Cardiac Surgical Procedure, run by Triemli Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaolin-activated Clotting Time (time frame: Routine measurements during cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.