Eickhoff 1987.
Methods | Site: Femoral to BK popliteal Study design: multicentre RCT Method of randomisation: sealed envelopes Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: none |
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Participants | Country: Scandinavia Setting: hospital No. of participants: 105 (55 PTFE, 50 HUV) Age: 68 yrs Sex: 60 male, 45 female Inclusion criteria: DM 12, critical ischaemia 80. BK fem‐pop for short distance IC or critical ischaemia, if no vein or CABG intended Exclusion criteria: short life expectancy, previous graft, Buerger's, coagulopathy |
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Interventions | PTFE versus HUV (diameter at discretion of operating surgeon) | |
Outcomes | Secondary patency | |
Notes | Post‐op anti‐thrombotic/coagulant therapy unknown | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear as to how the randomisation sequence was generated |
Allocation concealment (selection bias) | Low risk | Sealed envelopes used |
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 | Anticoagulation protocol not stated |