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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00829153

Registration number

NCT00829153

Ethics application status

Date submitted

22/01/2009

Date registered

26/01/2009

Date last updated

16/03/2010

Titles & IDs

Public title

U Clip Study - Study to Compare U Clip Anastomosis With Conventional Continuous Prolene Anastomosis

Scientific title

A Pilot, Randomised, Blinded Study to Compare U Clip Anastomosis With Conventional Continuous Prolene Anastomosis for Creating of Autologous Arteriovenous Fistulae

Secondary ID [1]

H8974

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Haemodialysis

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Devices - U Clip
Treatment: Surgery - Conventional prolene anastomosis

Experimental: U clip - Anastomosis with U clips

Active comparator: 2 - Prolene anastomosis

Treatment: Devices: U Clip
Interuppted nitional clips

Treatment: Surgery: Conventional prolene anastomosis
Continuous prolene anastomosis

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

A functioning fistula which is used for haemodialysis on three or more occasions.

Timepoint [1]

Until commencement of dialysis with the fistula

Secondary outcome [1]

Fistula patency as assessed clinically.

Timepoint [1]

For the life of the fistula

Secondary outcome [2]

Need for fistula intervention in order to maintain patency.

Timepoint [2]

For the life of the fistula

Eligibility

Key inclusion criteria

1. Requirement for AV fistula creation for haemodialysis
2. Pre operative upper limb venous and arterial duplex scan showing intended arterial lumen diameter of 2mm or more and vein diameter of 3mm or more.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Use of prosthetic graft for fistula creation.
2. Donor arterial lumen diameter less then 2mm
3. Recipient venous diameter less than 3mm.
4. Proximal venous thrombosis.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2007

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Launceston general Hospital - Launceston

Recruitment postcode(s) [1]

- Launceston

Funding & Sponsors

Primary sponsor type

Government body

Name

Royal Hobart Hospital

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The requirements for haemodialysis are increasing. There is now acceptance that the most durable AV fistulae are those created from the patients own veins. Use of the radiocephalic arteriovenous fistula as an autologous vascular access dates back to the 1960's. (Brescia MJ, Cimino JE. Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med 1966; 275: 1089 - 1092.) Once established, it has good long term survival and a low complication rate. However, the success rate at creation of a useable AV fistula are not good. In a meta-analysis published in 2005, the primary failure rate of a radiocephalic fistula was 15.3% and the primary and secondary patency rates were 62.5% and 66.0% at one year. (Rooijens PPGM, Tordoir JHM, Stijnen T, Burgmans JPJ, Smet AAEA and Yo TI. Radiocephalic wrist arteriovenous fistula for hemodialysis: meta-analysis indicates a high primary failure rate. Eur J Vasc Endovasc Surg 2004; 28, 583-589). Reasons for this are multiple but it appears as though the main determinants are the quality of the patients veins and the technical skill of the surgeon. Low patency rates are also seen in females and those with small veins and arteries. Creating an anastomosis between a small vein and artery is technically challenging. This is traditionally preformed with a continuous prolene suture. Recently, Medtronic have been marketing the U Clip Anastomotic Device. This is a self closing devise which could be called a vascular clip. Reported advantages of this clip include better patency rates and faster operations. However, to our knowledge there is no randomised evidence to support this with regards to AV fistulas.

The vascular anastomosis originally developed by Alexis Carrel used interrupted sutures. Over time this was replaced by a continuous suture technique which was felt to be quicker and had similar patency rates. However, microvascular, paediatric and neurovascular surgeons have shown that there are advantages to an interrupted technique. (Hattori H, Killen DA, Green JW. Influence of suture material and technic on patency of anastomosed arteries of less than 1.5mm. Am Surg. 1970; 36: 352 - 354. Cobbett JR. Microvascular surgery. Surg Clin N Am. 1962; 47: 521.). The reasons for the improved patency with interrupted anastomoses are firstly increased anastomotic compliance and flow rate and secondly elimination of the pursestring effect and puckering seen with continuous sutures.

In a prospective but non randomised study to compare interrupted U clips with historical published results, the patency rate of coronary anastomoses was 100% at 6 months using the U clips compare to a patency rate of 90 -100% in the published series. (Wolf RK, Alderman EL, Caskey MP et al. Clinical and six month angiographic evaluation of coronary arterial graft interrupted anastomoses by use of a self closing clip device: a multicentre prospective clinical trial. J Thorac cardiovasc Surg 2003; 126(1): 168 - 178.)

Reports from single centres have concluded that the U Clips offer the opportunity to create superior interrupted anastomoses for AV fistula, even in patients who would otherwise be considered poor candidates for fistula creation. (Ross JR. Creation of native arteriovenous fistulas with interrupted anastomoses using a self closing clip device - one clinics experience. Journal of vascular Access 2002; 3: 140 - 146). In this report with small numbers, the radiocephalic fistulas had an 8 week maturation rate of 93%. Of the 28 patients having a radiocephalic fistula, 10 had veins of between 1.0 - 1,5mm diameter.

The aim of this pilot study will be to assess if there is a clinical difference in the maturation rates of autologous AV fistulae when a clipped anastomosis is compared to a conventional prolene anastomosis.

Trial website

https://clinicaltrials.gov/study/NCT00829153

Trial related presentations / publications

Walker SR. U Clips for arteriovenous anastomosis: a pilot, randomized study. ANZ J Surg. 2012 Sep;82(9):630-2. doi: 10.1111/j.1445-2197.2012.06153.x. Epub 2012 Aug 20.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Stuart R walker, MBBS

Address

Country

Phone

03 6227064

Fax

[email protected]

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00829153

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00829153