Diaz 2001.
Methods | Study design : quasi‐randomised controlled trial | |
Participants |
Country : Spain Setting : hospital Number of centres : 1 Numbers : AngioSeal 75, manual compression 75 Age (mean (SD)) : AngioSeal 59 (9.5) years, manual compression 60 (9) years Sex : AngioSeal 65 M/10 F, manual compression 64 M/11 F Inclusion criteria : patients aged over 18 years undergoing coronary angiography and/or percutaneous transluminal coronary angioplasty (PTCA) via the femoral artery with or without implantation of stent Exclusion criteria : the drilling of the posterior wall of the artery during puncture, presence of a femoral murmur, history of aortic vascular surgery or lower limb and the presence of haematoma before randomisation |
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Interventions |
Intervention 1 : AngioSeal Intervention 2 : manual compression Sheath size : 6 Fr |
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Outcomes |
Primary : time to haemostasis; time to ambulation Secondary : Hhaematoma |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Sequence generated by odd and even numbers |
Allocation concealment (selection bias) | High risk | Allocation based on alternation |
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 | No missing data |
Selective reporting (reporting bias) | Unclear risk | Data on pre‐specified outcomes reported |
Other bias | Low risk | Study appears to be free from other sources of bias |