Hemosonics- VCU Cardiac Surgery Clinical Study

NCT02392247 | Completed Results

• 1 other identifier: FTU-002-007
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

Conditions

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (2)

• Clot Time

  Coagulation Function assessed at 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\] over the course of cardiac surgery until patient ICU transfer

  1 day

• Clot Stiffness

  Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer

  1 day

Study Arms (1)

Cardiac Surgery Patients

Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry

Device: Coagulation function

Interventions

Coagulation function DEVICE

Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)

Cardiac Surgery Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for this study will be recruited at the Virginia Commonwealth University Medical Center. The subject population will be representative of the local racial and ethnic population.

You may qualify if:

• Subject is scheduled for cardiac surgery involving bypass circuit
• Subject is older than 18 years
• Subject is willing to participate and he/she has signed a consent form

You may not qualify if:

• Subject is unable to provide written informed consent
• Subject is incarcerated at the time of the study
• Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
• Patients on emergency cases

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• HemoSonics LLC: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Limitations and Caveats

This is a descriptive, single-cohort study, not an hypothesis-testing trial. The objective was device performance comparison. As there is no gold standard technology, this study could not determine which method was 'best' or 'superior'.

Results Point of Contact

• Title: Dr.Bruce Spiess, Principal Investigator
• Organization: Virginia Commonwealth University

bruce.spiess@vcuhealth.org

804-828-2267

Study Officials

• Bruce Speiss, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)