TABLE I.
Randomized controlled trials for primary prophylaxis in cancer-related major abdominal and pelvic surgery
Trial | Surgical setting | Cancer patients (n) | Regimen | Duration of treatment | Outcome | Incidences | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Study | Control | vte | Major bleeding | |||||||||
Study (%) | Control (%) | p Value | Study (%) | Control (%) | p Value | |||||||
Enoxacan Study Group, 1997 10 | Abdominal and pelvic | 631 | Enoxapari 40 mg daily | ufh 5000 IU 3 times daily | 10 Days | vte on bilateral venography or pulmonary scintigraphy | 14.7 | 18.2 | >0.05 | 4.1 | 2.9 | >0.05 |
McLeod et al., 2001 11 | Colorectal | 324 | Enoxaparin 40 mg daily | ufh 5000 IU 3 times daily | Up to 10 days | pe, venographic dvt at postoperative days 5, 9 | 13.9 | 16.9 | 0.052 | 2.7a | 1.5a | 0.136a |
Agnelli et al., 2005 12 | Major abdominal | 1941 | Fondaparinux 2.5 mg daily | Dalteparin 5000 IU daily | 5–9 Days | Venographic dvt or pe up to postoperative day 10 | 4.7 | 7.7 | <0.05 | 3.4 | 2.5 | 0.355 |
Bergqvist et al., 2002 13 | Abdominal and pelvic | 332 | Enoxaparin 40 mg daily | Enoxaparin 40 mg daily | 27–31 Days (study) 6–10 Days (control) | Bilateral venography between days 25 and 31 | 4.8 | 12.0 | 0.02 | 0.4 | 0 | >0.99 |
Rasmussen et al., 2006 14 | Major abdominal | 198 | Dalteparin 5000 IU daily | Dalteparin 5000 IU daily | 28 Days (study) 7 Days (control) | Venographic vte on postoperative days 7–28 | 8.8 | 19.6 | 0.03 | 0.5a | 1.8a | >0.05a |
Results for the overall study population, including cancer and noncancer patients.
vte = venous thromboembolism; ufh = unfractionated heparin; pe = pulmonary embolism; dvt = deep vein thrombosis.