Table 2.

Complications

	Control	Intervention	p value
	n = 120	n = 120
Cardiovascular	18 (15%)	13 (11%)	0.336
Respiratory	10 (8%)	12 (10%)	0.655
Cerebrovascular	5 (4%)	0 (0%)	0.024
Acute kidney failure	10 (8%)	11 (9%)	0.819
GI bleed	1 (1%)	2 (2%)	0.561
Confusion	19 (16%)	20 (17%)	0.861
Sepsis	8 (7%)	8 (7%)	1.00
DVT	1 (1%)	0 (0%)	0.316
Wound infection	0 (0%)	2 (2%)	0.156
Delayed healing	0 (0%)	2 (2%)	0.156
UTI	10 (8%)	4 (3%)	0.098
Decubitas	1 (1%)	0 (0%)	0.316
Haematoma	1 (1%)	3 (3%)	0.313
Haematological	13 (11%)	12 (10%)	0.883
Number of patients with one or more complications (ITT)	61/120 (51%)	55/120 (46%)	0.439
Number of patients with one or more complications (PP)	61/120 (51%)	43/100 (43%)	0.247