Gwechenberger 1997.
Methods | Study design : randomised study | |
Participants |
Country : Austria Setting : hospital Number of centres : 1 Numbers: VasoSeal 33, manual compression 33 Age (mean (SD)) : VasoSeal 59.8 (8.1) years, manual compression 56.9 (10.8) years Sex : VasoSeal 31 M/2 F, manual compression 24 M/5 F Inclusion criteria : patients undergoing diagnostic or therapeutic percutaneous transluminal coronary angioplasty Exclusion criteria : not stated |
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Interventions |
Intervention 1 : VasoSeal Intervention 2 : manual compression Sheath size : not stated |
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Outcomes |
Primary : time to haemostasis Secondary : complications (arteriovenous fistula, pseudoaneurysm, bleeding, haematoma > 6 cm in diameter) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "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) | Unclear risk | Study outcomes are not clearly reported |
Other bias | Unclear risk | Insufficient information to permit judgement of high or low risk |