Trial Outcomes & Findings for Stage 3 Fontan Operation Liver Ultrasound Study (NCT NCT02269709)

Last Updated: 2018-01-12

Results Overview

ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

0-6 months

Results posted on

2018-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	ARFI Ultrasound Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness.
Time of Enrollment STARTED	21
Time of Enrollment COMPLETED	18
Time of Enrollment NOT COMPLETED	3
Follow-up #1 (24-72 Hours Post-surgery) STARTED	18
Follow-up #1 (24-72 Hours Post-surgery) COMPLETED	17
Follow-up #1 (24-72 Hours Post-surgery) NOT COMPLETED	1
Prior to Hospital Discharge STARTED	17
Prior to Hospital Discharge COMPLETED	17
Prior to Hospital Discharge NOT COMPLETED	0
Six Month Follow-up STARTED	17
Six Month Follow-up COMPLETED	5
Six Month Follow-up NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	ARFI Ultrasound Subjects were pediatric patients who had undergone a repair of a heart defect, called a Fontan operation. Patients underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure its stiffness.
Time of Enrollment Withdrawal by Subject	3
Follow-up #1 (24-72 Hours Post-surgery) Lost to Follow-up	1
Six Month Follow-up Lost to Follow-up	12

Baseline Characteristics

The age of each gender group (males and females) is compared.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARFI Ultrasound n=18 Participants Subjects were pediatric patients who had undergone a Fontan operation. Subjects underwent an ultrasound before and after the Fontan operation. The ultrasound scan used acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a non-invasive scan that uses sound waves to create images of the liver and measure the stiffness of the tissue.
Age, Continuous	33.5 Months STANDARD_DEVIATION 10.5 • n=18 Participants
Sex: Female, Male Female	6 Participants n=18 Participants
Sex: Female, Male Male	12 Participants n=18 Participants
Age by Sex Age of Male Subjects	34 Months n=12 Participants • The age of each gender group (males and females) is compared.
Age by Sex Age of Female Subjects	33 Months n=6 Participants • The age of each gender group (males and females) is compared.

PRIMARY outcome

Timeframe: 0-6 months

Population: As shown in the participant flow, data was not captured for follow up time points 1 and 2 for 1 participant. At time point 3 data is only available for 5 participants.

Outcome measures

Outcome measures
Measure	ARFI Ultrasound n=18 Participants Subjects underwent an ultrasound scan before and after the Fontan operation.
Shear Wave Speed (Liver Stiffness) Liver Stiffness at baseline	1.18 meters per second Standard Deviation 0.29
Shear Wave Speed (Liver Stiffness) Liver Stiffness follow-up tim1 (24-72 hours later)	2.28 meters per second Standard Deviation 0.31
Shear Wave Speed (Liver Stiffness) Liver Stiffness follow-up time 2 (7 days later)	2.22 meters per second Standard Deviation 0.38
Shear Wave Speed (Liver Stiffness) Liver stiffness follow-up time 3 (6 months)	2.08 meters per second Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline and Follow Up Number 1 (approximately 24 -72 hours later)

Population: Subjects who had undergone the Fontan operation and who had a central line placed. Blood pressure values were obtained from chart review.

Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.

Outcome measures

Outcome measures
Measure	ARFI Ultrasound n=9 Participants Subjects underwent an ultrasound scan before and after the Fontan operation.
IVC Pressure IVC pressure before Fontan operation	7.2 mmHg Standard Error 2.6
IVC Pressure IVC pressure after Fontan operation (24-72 hours)	16.44 mmHg Standard Error 3.3

Adverse Events

ARFI Ultrasound

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

Frank W. DiPaola, MD

University of Michigan

Phone: 734-763-9650

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place