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. 2016 Mar 7;2016(3):CD009541. doi: 10.1002/14651858.CD009541.pub2

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
Interventions Intervention 1 : AngioSeal
Intervention 2 : manual compression
Sheath size : 6 Fr
Outcomes Primary : time to haemostasis; time to ambulation
Secondary : Hhaematoma
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