Venous Thromboembolism in Cancer Patients Undergoing Major Abdominal Surgery: Prevention and Management

Table 3

Studies of VTE prophylaxis with fondaparinux in patients undergoing major abdominal surgery.

Trial

Method

Patients (𝑛)

Study population

Regimen

Incidences

Study

Control

Outcome

Followup

VTE

Major bleeding

Study (%)

control (%)

𝑃 value

Study (%)

Control (%)

𝑃 value

Turpie et al. 2007 [135]

Randomized, double-blind, placebocontrolled superiority trial

842

Patients undergoing abdominal surgery

Fondaparinux 2.5 mg sc × 5–9 days, starting 6–8 hours postoperatively with intermittent pneumatic compression

Placebo 2.5 mg sc × 5–9 days, starting 6–8 hours postoperatively with intermittent pneumatic compression

Efficacy outcome—VTE up to day 10 Safety outcomes-major bleeding and all-cause mortality

32 days

1.7

5.3

𝑃=0.004

1.6

0.2

0.006

Agnelli et al. 2005 [136]

double-blind double-dummy randomized study

2048

Patients undergoing major abdominal surgery

Fondaparinux 2.5 mg sc q.d. × 5–9 days started 6 hours postoperatively

Dalteparin 5000 units sc q.d. × 5–9 days. The first two doses of dalteparin, 2500 units each, were given 2 hours before surgery and 12 hours after the preoperative administration

Primary outcome—DVT detected by bilateral venography, symptomatic, confirmed DVT or PE Safety outcome-major bleeding

10 days

4.6

6.1

0.144

3.4

2.4

0.122

VTE: venous thromboembolism, DVT: deep vein thrombosis, PE: pulmonary embolism, sc: subcutaneous.