Favoured Study (Version 8)

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, factorial-design trial to assess the effect of aspirin & fish oil in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV/ V chronic renal disease requiring haemodialysis

• IRAS ID

  27426

• Contact name

  Chris McIntyre

• Sponsor organisation

  Australian Kidney Trials Network, University of Queensland

• Eudract number

  2009-014868-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Platelets are cell fragments which are involved in blood clotting. This study aims to determine whether the use of the anti-platelet agents aspirin and fish oil, either alone or in combination (in a factorial design), will effectively reduce the risk of early thrombosis (clotting) in newly created arterio-venous fistulae (AVF, a surgical join of an artery and a vein). The study population is patients with stage IV or V chronic kidney disease (CKD) who require or will require haemodialysis and are scheduled to undergo creation of an AVF and are not currently taking antiplatelet agents. The primary outcome is patency of the AVF at three months after surgery. Other outcomes include functional patency at six months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/18

• Date of REC Opinion

  14 Jul 2010

• REC opinion

  Further Information Favourable Opinion