Scharn 2008.
Methods | Site: AK Study design: RCT Method of randomisation: controlled by the BOA‐trial agency using a dedicated computer program Blinding: unblinded, intention to treat Exclusions post randomisation: 8 (6%) Losses to follow up: 13 (9%) |
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Participants | Country: the Netherlands Setting: hospital No. of participants: 137 (137 limbs with 8 excluded; 59 HBD, 70 HUV) Age (median): 65 yrs Sex: 87 males, 50 females Inclusion criteria: severe claudication, rest pain, tissue loss Exclusion criteria: patients younger than 30 or older than 90 yrs of age; patients with an ABI higher than 0.8 at rest, emergency surgery for trauma, acute thrombosis or embolism of the popliteal artery, the diagnosis or treatment for malignancy within 12 months, hospital in‐patient treatment for cardiac failure in the previous 6 months, the absence of the possibility for adequate follow up or contraindications for anticoagulant drug therapy |
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Interventions | Heparin bonded Dacron and HUV (diameter at discretion of operating surgeon) Aspirin 80 mg daily or coumarin derivates (Sintrom) |
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Outcomes | Primary patency. 5‐year follow‐up | |
Notes | No consistent anticoagulation protocol. No compliance checks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was controlled by the BOA‐trial agency using a dedicated computer program." |
Allocation concealment (selection bias) | Low risk | Not specifically stated but assumed done as BOA‐trial agency involved |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors and patients not obviously blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses, clear life table data |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Unclear risk | No consistent anticoagulation protocol |