Trial Outcomes & Findings for Hemosonics- VCU Cardiac Surgery Clinical Study (NCT NCT02392247)

NCT ID: NCT02392247

Last Updated: 2016-07-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 52 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2016-07-12

Participant Flow

Participant milestones

Measure	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. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU. Blood specimen collection
Overall Study STARTED	52
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU. Blood specimen collection
Overall Study Withdrawal by Subject	1
Overall Study Surgery cancelled; no data	1

Baseline Characteristics

Hemosonics- VCU Cardiac Surgery Clinical Study

Baseline characteristics by cohort

Measure	Cardiac Surgery Patients n=50 Participants Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 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)

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

Outcome measures

Measure	Cardiac Surgery Patients n=200 blood samples 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. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU. Blood specimen collection
Clot Time Reaction Time R (TEG)	4.9 min Standard Deviation 1.2
Clot Time Heparinase Clot Time (SEER)	3.3 min Standard Deviation 0.6

PRIMARY outcome

Timeframe: 1 day

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

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

Outcome measures

Measure	Cardiac Surgery Patients n=200 blood samples 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. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU. Blood specimen collection
Clot Stiffness TEG G force	8.5 hPa Standard Deviation 3.7
Clot Stiffness SEER Clot stiffness	18.4 hPa Standard Deviation 9.2

Adverse Events

Cardiac Surgery Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Bruce Spiess, Principal Investigator

Virginia Commonwealth University

Phone: 804-828-2267

Email: bruce.spiess@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place