Schmitz 2002.
Methods | Study design: randomised, double‐blind clinical trial | |
Participants | Country: United States No. of participants: 24 Age: 46 to 58 years Gender: M = 11, F = 13 Inclusion criteria: newly placed PTFE graft Exclusion criteria: patients needing fistula revision; history of gastro‐intestinal bleeding; already taking warfarin or an anti‐platelet agent; terminal or life‐threatening disease; pregnancy; or malignant hypertension |
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Interventions | Treatment: 4000 mg fish oil once daily Control: placebo od Duration: 12 months (medication started within 2 weeks of graft placement) |
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Outcomes | Primary: graft thrombosis | |
Notes | PTFE grafts | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Permuted block randomisation scale |
Allocation concealment (selection bias) | Low risk | No pre‐allocation bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo and treatment capsules manufactured by the same company |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to assess |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants received the appropriate treatment. Only one was lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Pre‐study protocol not available |
Other bias | Low risk | Nil obvious |