3D Contrast Enhanced UltraSound in perfusion studies of early renal transplants

ISRCTN	ISRCTN44785771
DOI	https://doi.org/10.1186/ISRCTN44785771
Secondary identifying numbers	10201

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Ben Stenberg
Scientific

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Phone	+44 191 2336161 Ext: 26552
Email	ben.stenberg@nuth.nhs.uk

Study design	Non-randomised; Interventional; Design type: Diagnosis, Not specified
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	3D Contrast Enhanced UltraSound in perfusion studies of early renal transplants: a non-randomised study
Study acronym	3D CEUS
Study objectives	To assess the sensitivity of Three dimensional (3D) contrast enhanced ultrasound (CEUS) of detecting perfusion defects in kidney transplants immediately post-surgery. Also, determine any prognostic value from the haemodynamic factors of the contrast in predicting graft outcome. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10201
Ethics approval(s)	Newcastle & North Tyneside 2, 10/02/2011, ref: 11/H0907/1
Health condition(s) or problem(s) studied	Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention	Contrast enhanced ultrasound: Single examination using a 2.4mls injection of Sonovue contrast media.
Intervention type	Other
Primary outcome measure	Perfusion defect rates using 99mTc-diethylenetriamine pentaacetic acid (DTPA) renogram
Secondary outcome measures	Graft viability up to 3 months post-op measured by serum results and histology reports.
Overall study start date	04/03/2011
Completion date	31/07/2012

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 105; UK Sample Size: 105
Key inclusion criteria	1. All renal transplant patients that undergo surgery within the collection period for the study until study population is acheived (N=105) 2. Male & Female ; Lower Age Limit 18 years
Key exclusion criteria	1. Any patient under 18 years of age 2. A pregnant patient and 3. Any patient excluded due to contraindications as listed in the manufacturers guidelines for the contrast media used
Date of first enrolment	04/03/2011
Date of final enrolment	31/07/2012

Freeman Road

Newcastle upon Tyne
NE7 7DN
United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

"ROR"	https://ror.org/05p40t847

Charity

Northern Counties Kidney Research Fund (UK)
Private sector organisation / Other non-profit organizations

Society and College of Radiographers (SCoR) (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017		Yes	No

19/01/2016: No publications found on PubMed.
28/02/2018: Added publication reference.