Cardiopulmonary BypassNCT02392247

Hemosonics- VCU Cardiac Surgery Clinical Study

An observational study of Cardiopulmonary Bypass, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Cardiopulmonary Bypass
What is being tested?: Coagulation function
Type of treatment: Medical device
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Sep 2015
Phase: Observational
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 89 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Hemosonics- VCU Cardiac Surgery Clinical Study Protocol

Read the detailed description

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.

Conditions: Cardiopulmonary Bypass
Being tested: Coagulation function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02392247
Study group	Role	What they receive
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 Receives: Device: Coagulation function

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Sep 2015

First posted18 Mar 2015 (estimated)
Study startApr 2015
Primary completionSep 2015
Study completionSep 2015

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.
Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
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: Observational
Time perspective: Prospective
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02392247
Sponsor's protocol ID: FTU-002-007
Status last verified: Jun 2016
First submitted: 12 Mar 2015
Last updated: 12 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
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A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Not yet recruiting
Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium

All Cardiopulmonary Bypass trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemosonics- VCU Cardiac Surgery Clinical Study Protocol
ClinicalTrials.gov ID: NCT02392247
Acronym / sponsor ID: FTU-002-007
Conditions: Cardiopulmonary Bypass
Study type: Observational
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: HemoSonics LLC
Study start: Apr 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 18 Mar 2015 (estimated)
Results: Posted 12 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cardiac Surgery Patients	–	Device: Coagulation functionSingle 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

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

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
Coagulation functionCoagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)	Device	Cardiac Surgery Patients

Primary outcome

Clot Time
Time frame: 1 day
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
Clot Stiffness
Time frame: 1 day
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

Results and safety

Results posted to the registry on 12 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardiac Surgery Patients	52	50

Primary outcome: Clot Time

Time frame: 1 day. Mean (Standard Deviation). Unit: min

Measure	Cardiac Surgery Patients n = 50
Reaction Time R (TEG)	4.9 (1.2)
Heparinase Clot Time (SEER)	3.3 (0.6)

Cardiac Surgery Patients: Slope: 0.34 (95% CI 0.26 to 0.44), p <0.001, Deming Regression

Population analysed: Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)

Primary outcome: Clot Stiffness

Time frame: 1 day. Mean (Standard Deviation). Unit: hPa

Measure	Cardiac Surgery Patients n = 50
TEG G force	8.5 (3.7)
SEER Clot stiffness	18.4 (9.2)

Cardiac Surgery Patients: Slope: 3.1 (95% CI 2.9 to 3.4), p <0.001, Deming regression

Population analysed: Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\]

Adverse events

Time frame: one day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cardiac Surgery Patients	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): 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'.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cardiopulmonary Bypass

Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation
Recruiting
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Not yet recruiting
Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium

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.

Bruce Speiss, M.D. principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiopulmonary Bypass, run by Virginia Commonwealth University at 1 site in United States.

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 3 inclusion and 4 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 12 Jul 2016). 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?

Clot Time (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT02392247.

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 12 Jul 2016.