Carere 2000.
| Methods | Study design : randomised controlled trial | |
| Participants |
Country : Canada Setting : hospital Number of centres : 1 Numbers : ProStar‐Plus 50, C‐Clamp 50 Age (mean (SD)) : ProStar‐Plus 62 (11) years, C‐Clamp 59 (12) years Sex : ProStar‐Plus 44 M/6 F, C‐Clamp: 39 M/11 F Inclusion criteria : patients with elective or urgent coronary angioplasty with or without stenting in whom same‐day discharge was reasonable Exclusion criteria : clinical evidence of peripheral arterial disease, pre‐existing femoral haematoma, serum creatinine > 150 mmol/L, blood pressure > 180/100 mmHg, participating in another research project |
|
| Interventions |
Intervention 1 : ProStar‐Plus Intervention 2 : C‐Clamp Sheath size : 8 Fr |
|
| Outcomes |
Primary : time to mobilisation; time to discharge Secondary : insertion failure; need for vascular surgery; external bleeding after initial haemostasis; an ooze of blood; haematomas (small < 5 cm, medium 5 to 10 cm, large > 10 cm); blood transfusion; participant satisfaction; cost per participant |
|
| Notes | Participants randomised to ProStar were mobilised after 4 hours; manual compression participants were mobilised 6 hours after sheath removal | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated" 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 of other sources of bias |