Trial Outcomes & Findings for Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease (NCT NCT02090881)

Results Overview

A flow phantom was used to compare Time average mean maximum velocity measurements from a Philips IU-22 and Zonare Z-One ultrasound machine. 25 children with SCD (aged 2-15 years) attending the outpatient clinic at St. Mary's Hospital, Imperial College Healthcare NHS Trust as part of the NHS Sickle Cell \& Thalassaemia (SC\&T) screening programme, were studied. The Time Averaged Mean of the Maximum (TAMM) velocities in the middle cerebral artery (MCA) and stroke risk categorisation using the two ultrasound machines were compared.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

4 months

Results posted on

2023-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound Scan in Ages 2-16 Years Children aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme. Ultrasound scan: Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound Scan in Ages 2-16 Years n=25 Participants Children aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme. Ultrasound scan: Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
Age, Categorical <=18 years	25 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants
Sex: Female, Male Female	14 Participants n=25 Participants
Sex: Female, Male Male	11 Participants n=25 Participants
Region of Enrollment United Kingdom	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 4 months

A flow phantom was used to compare Time average mean maximum velocity measurements from a Philips IU-22 and Zonare Z-One ultrasound machine. 25 children with SCD (aged 2-15 years) attending the outpatient clinic at St. Mary's Hospital, Imperial College Healthcare NHS Trust as part of the NHS Sickle Cell \& Thalassaemia (SC\&T) screening programme, were studied. The Time Averaged Mean of the Maximum (TAMM) velocities in the middle cerebral artery (MCA) and stroke risk categorisation using the two ultrasound machines were compared.

Outcome measures

Outcome measures
Measure	Ultrasound Scan in Ages 2-16 Years n=25 Participants Children aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme. Ultrasound scan: Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines. Philips IU-22	120 cm/sec Interval 102.0 to 130.0
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines. Zonare Z-One	120 cm/sec Interval 102.0 to 130.0

Adverse Events

Ultrasound Scan in Ages 2-16 Years

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 Mohammed Aslam

Imperial College Healthcare NHS Trust

Phone: 02083831000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place