Hermanides 2010.
| Methods | Study design : single‐centre retrospective randomised study | |
| Participants |
Country : The Netherlands Setting : hospital Number of centres : 1 Numbers: AngioSeal 313, manual compression 314 Age (mean (SD)) : AngioSeal 64.5 (11.3) years, manual compression 64.0 (11.0) years Sex : AngioSeal 238 M/75 F, manual compression 239 M/75 F Inclusion criteria : patients undergoing PCI via femoral artery access Exclusion criteria : age < 18 years; serious co‐morbidity such as cancer; advanced cerebrovascular disease; unwilling or unable to sign the consent form for participation; females of childbearing age not using medically prescribed contraceptives; unsuitable access site (severe peripheral vascular disease, poor location) |
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| Interventions |
Intervention 1 : AngioSeal Intervention 2 : manual compression Sheath size : 6 Fr |
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| Outcomes |
Primary : combined incidence of (1) severe haematoma > 5 cm at the puncture site or groin bleeding resulting in prolonged hospital stay, transfusion and/or surgical intervention at the puncture site; (2) arteriovenous fistula formation at the puncture site and/or surgical intervention at the puncture site Secondary : decrease in haemoglobin 1 day after inclusion; hospital admission duration |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by means of a computer program in blocks (randomly changing block size)" Comment: random sequence generation. Study was judged to be at low risk of selection bias |
| 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 | Low risk | Quote: "A blinded independent clinical endpoint committee adjudicated all clinical endpoints" Comment: Blinding of outcome assessors was done. Study was judged to be at low risk of performance bias |
| 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 |