Amine 1999.
| Methods | Study design : randomised study | |
| Participants |
Country : France Setting : hospital Number of centres : 1 Numbers: Techstar 50, manual compression 50 Age (mean (SD)) : Techstar 61 (10) years, manual compression 60 (8) years Sex : Techstar 72 M/28 F, manual compression 70 M/30 F Inclusion criteria : patients undergoing diagnostic coronography Exclusion criteria : patients in an acute phase of myocardial infarct, with or without thrombolysis treatment, with known anomalies of coagulation or plaque counting, with severe and uncontrollable arterial hypertension (systolic > 190 mmHg and diastolic >110 mmHg) and inflammation of arthritis of the inferior limbs |
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| Interventions |
Intervention 1 : PerClose Intervention 2 : manual compression Sheath size : 6 Fr |
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| Outcomes |
Primary : clinical and ultrasound complications during the first 15 days after treatment Secondary : time to haemostasis; time to ambulation (defined as time between removal of the closure device and the moment the participant could stand up and walk for 5 metres); success rate of the system Clinical exams at 1 hour and 24 hours looked for signs of ischaemia, haematoma, re‐bleeding, pseudo‐aneurysm and arteriovenous fistula. Doppler echographic examination at 24 hours looked for signs of haematoma, pseudo‐aneurysm, arteriovenous fistula, intra‐arterial thrombus or the presence of arterial narrowing at the puncture level |
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| Notes | Coronography with 6 Fr sheath for all participants | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised in blocks of 4 for the manual compression group and by envelope opened at the end of the coronography procedure for the suture device group" Comment: Envelopes were used, so sequence generation was probably random. Study was judged to be at low risk of selection bias |
| Allocation concealment (selection bias) | Low risk | Quote: "closed envelope system" Comment: Envelopes were sealed, so the study was judged to be at low risk of selection bias |
| 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 | Insufficient information to permit judgement of high or low risk |
| Other bias | Unclear risk | Insufficient information to permit judgement of high or low risk |