Grontoft 1998.
| Methods | Study design: randomised, double‐blind, multicentre, clinical trial | |
| Participants | Country: Sweden and Finland (8 Swedish, 1 Finnish centre) No. of participants recruited: 258 (285 operations) Non‐evaluability amongst randomised operations: consent withdrawn = 2, no medication taken = 4, no new anastomosis = 11, no data recovered = 1 Age: placebo 58 ± 15, ticlopidine 56 ± 15 Gender: placebo M = 77, F = 47; ticlopidine M = 75, F = 43 Inclusion criteria: patients with chronic renal failure predialysis or on dialysis; patients requiring AVF Patients in whom first operation failed could be re‐entered after washout period Exclusion criteria: patients requiring anti‐platelet or anticoagulant therapy; history of hepatic disease; severe or malignant hypertension; gastrointestinal ulcer; bleeding disorder; reduced white blood cells or platelets |
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| Interventions | Treatment: ticlopidine 250 mg bid Control: placebo bid Duration: aim to start 7 days (minimum 3 days) pre‐ and 28 days post‐surgery |
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| Outcomes | Primary: fistula thrombosis Secondary: Biochemical markers: urea, haemoglobin and cholesterol levels |
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| Notes | Native AV fistulae, transposition grafts and synthetic grafts Recruitment interrupted for 4 months due to serious adverse event |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Minimisation scheme based on the 4 weighted stratification variables of the participating centre |
| Allocation concealment (selection bias) | Low risk | No pre‐allocation bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Potential risk due to the re‐entry of certain participants into randomisation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Potential risk due to the re‐entry of certain participants into randomisation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data missing on 267 operations |
| Selective reporting (reporting bias) | Unclear risk | Pre‐study protocol not available |
| Other bias | High risk | Participants in whom the first operation failed could be re‐entered after a 3‐week washout period |