Condition category
Urological and Genital Diseases
Date applied
29/06/2012
Date assigned
29/06/2012
Last edited
19/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ben Stenberg

ORCID ID

Contact details

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 191 2336161 Ext: 26552
ben.stenberg@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10201

Study information

Scientific title

3D Contrast Enhanced UltraSound in perfusion studies of early renal transplants: a non-randomised study

Acronym

3D CEUS

Study hypothesis

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

Newcastle & North Tyneside 2, 10/02/2011, ref: 11/H0907/1

Study design

Non-randomised; Interventional; Design type: Diagnosis, Not specified

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/03/2011

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 105; UK Sample Size: 105

Participant 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

Recruitment start date

04/03/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Northern Counties Kidney Research Fund (UK)

Alternative name(s)

NCKRF

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Society and College of Radiographers (SCoR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/01/2016: No publications found on PubMed