CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan

Table 3 Outcomes for population 1

Outcome	LMWH allocation (n = X)	Aspirin allocation (n = X)	Absolute risk difference	95% confidence interval
Any venous thromboembolism	n (%)	n (%)	X	X – X
Type of venous thromboembolism
Pulmonary embolism	n (%)	n (%)	X	X – X
Deep venous thrombosis	n (%)	n (%)	X	X – X
Both Pulmonary embolism and deep venous thrombosis	n (%)	n (%)	X	X – X
Above knee deep venous thrombosis	n (%)	n (%)	X	X – X
Below knee deep venous thrombosis	n (%)	n (%)	X	X – X
Death	n (%)	n (%)	X	X – X
Re-operation (90 days)	n (%)	n (%)	X	X – X
Reoperation (6 months)	n (%)	n (%)	X	X – X
Re-admission	n (%)	n (%)	X	X – X
Major bleeding	n (%)	n (%)	X	X – X
Pain and function (median and IQR)^a
Oxford Hip Score	X (X – X)	X (X – X)	X	X – X
Oxford Knee Score	X (X – X)	X (X – X)	X	X – X
EQ-5D	X (X – X)	X (X – X)	X	X – X
EQ-VAS	X (X – X)	X (X – X)	X	X – X

ISSN: 1745-6215