NCT02588976

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 3, 2018

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

October 23, 2015

Results QC Date

March 8, 2018

Last Update Submit

April 3, 2018

Conditions

Diagnostic Techniques and ProceduresCardiac Surgical Procedure

Keywords

Activated clotting timeSonoclot

Outcome Measures

Primary Outcomes (1)

  • Kaolin-activated Clotting Time

    Routine measurements during cardiac surgery

Secondary Outcomes (1)

  • Glass Bead Activated Clotting Time

    Routine measurements during cardiac surgery

Study Arms (1)

ACT measurements

OTHER

ACT measurements by SONOCLOT Analyzer during cardiac surgery

Device: Sonoclot Analyzer

Interventions

Sonoclot AnalyzerDEVICE

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

ACT measurements

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all consecutive cardiac surgery patients

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18420846BACKGROUND

Results Point of Contact

Title
Director Clinical Trial
Organization
Triemli City Hospital
christoph.hofer@triemli.stzh.ch
+41 44 416 25 52

Study Officials

  • Michele Genoni, MD

    Triemli City Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 28, 2015

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

May 4, 2018

Results First Posted

April 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share