Chen 2013.
| Methods | Study design : randomised study | |
| Participants |
Country : Taiwan Setting : hospital Number of centres : 1 Numbers : Boomerang 30, PerClose 30 Age (mean (SD)) : Boomerang 63.1 (9.9) years, PerClose mean 69.8 (10.6) years Sex : QuickSeal 21 M/9 F, manual compression 20 M/10 F Inclusion criteria : patients undergoing percutaneous interventional procedure via the common femoral artery Exclusion criteria : patients with “double wall” arterial punctures, intraluminal thrombi, pseudoaneurysms, haematomas, arteriovenous (AV) fistulas or infection in the target artery lesion; history of protamine allergy; previous injections of neutral protamine hagedorn (NPH). We also excluded patients who required a long sheath (> 23 cm) |
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| Interventions |
Intervention 1 : Boomerang Intervention 2 : PerClose Sheath size : 7 Fr |
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| Outcomes |
Primary : procedure success; device success; device deployment time; device dwell time; manual compression time; time to ambulation; major complications Secondary : pain score; minor complications |
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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" 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 | Low risk | No missing data |
| Selective reporting (reporting bias) | Low risk | Data on pre‐specified outcomes reported |
| Other bias | Low risk | Study appears to be free from other sources of bias |