Veasey 2008.
| Methods | Study design : randomised single‐blind prospective trial | |
| Participants |
Country : United Kingdom Setting : district general hospital Number of centres : 1 Numbers: AngioSeal 208, StarClose 193 Age (mean (SD)) : AngioSeal 65.3 (10.6) years, StarClose 66.5 (10.8) years Sex : AngioSeal 115 M/93 F, StarClose 107 M/86 F Inclusion criteria : patients undergoing elective day‐case diagnostic coronary angiography with immediate post‐procedure mobilisation Exclusion criteria : patients with a diagnosis of unstable angina or acute myocardial infarction; significant peripheral vascular disease; previous peripheral vascular surgery; pregnant; unable to give written informed consent; younger than 18 years; previous femoral artery complication from coronary angiography |
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| Interventions |
Intervention 1 : AngioSeal Intervention 2 : StarClose Sheath size : 5 Fr |
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| Outcomes |
Primary : complications (induration; haematoma; bleeding; retroperitoneal bleed; pseudoaneurysm; leg ischaemia; access site infection) Secondary : participant satisfaction; pain scores Follow‐up : 1 week post procedure |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised to" Comment: insufficient information to permit judgement of high or low risk |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of high or low risk |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding, but review authors judged that outcomes and outcome measurements are not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement of high or low risk |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcomes are not clearly stated |
| Selective reporting (reporting bias) | Unclear risk | Outcomes are not clearly stated |
| Other bias | Unclear risk | Insufficient information to permit judgement of high or low risk |