| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN27307877 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0158153706 |
| Public title | Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters: a randomised controlled trial. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Haematological Disorders |
| Study hypothesis | To compare the effectiveness of 46.7% trisodium citrate versus unfractionated heparin (5000 IU/ml) in preventing clotting of tunnelled haemodialysis catheters. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Any patient who require a new tunnelled catheter for haemodialysis. Patients fall into 3 groups:
1. Patients who present to the Kidney unit of the UHNS with kidney failure needing maintenance haemodialysis
2. Patients who have to switch from peritoneal to haemodialysis because of problems with their peritoneal dialysis
3. Existing haemodialysis patients who need tunnelled catheters because their arterivenous fistulas or tunnelled catheters have failed.
The decision to place a tunnelled dialysis catheter is made by one of the renal Consultants entirely on the basis of clinical need. Patients will be invited to take part prior to insertion of the tunnelled dialysis catheter. Randomisation will be by sealed envelopes. The only differences in dialysis care that pts will have is the locking agent, otherwise patients will have the same treatment whether they are dialysing in our main renal unit in Stoke or our two satellite units at Stafford and Leighton. They will be followed up and all dialysis related issues will be documented as per current practice. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | Not provided at time of registration |
| Anticipated start date | 01/02/2005 |
| Anticipated end date | 01/08/2006 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters |
| Primary outcome measure(s) | Catheter blood flow of less than 250mls/minute and/or venous pressure of more than 260 mmHG, persisting for one hour/session, in two consecutive sessions. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | North Staffordshire Research and Development Consortium (UK)
|
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr M Abdalla |
| Contact details | Nephrology Department
North Staffordshire Royal Infirmary
Princes Road
Hartshill
Stoke-on-Trent
United Kingdom
ST4 7LN |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN27307877 |
| Date last extracted from ISRCTN register | 17/04/2008 |
