TABLE III.
Randomized controlled trials for primary prophylaxis in cancer-related gynecologic surgery
| Trial | Patients (n) | Regimen | Duration of treatment | Outcome | Incidences | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Control | vte | Major bleeding | ||||||||
| Study(%) | Control (%) | p Value | Study (%) | Control (%) | p Value | ||||||
| Heilmann et al., 1989 19 | 300 | lmwh 1500 IU daily | ufh 5000 IU 3 times daily | 7 Days | pe, dvt by impedance plethysmography to day 7 | 1.3 | 4.0 | >0.05 | No significant difference in clinical and laboratory measures, specific incidence of major bleeding not cited | ||
| Clarke–Pearson et al., 1990 20 | 200 | ufh 5000 IU every 8 hours pre- and postoperatively | No prophylaxis | Until discharge | pe, dvt by 125I-labelled fibrinogen scan, impedance plethysmography to day 30 | 6.2 | 18.4 | 0.008 | No significant difference in clinical and laboratory measures, specific incidence of major bleeding not cited | ||
| Fricker et al., 1988 21 | 80 | Dalteparin 2500 IU 2 hours preoperatively and at 12 hours, then 5000 IU daily | ufh 5000 IU 2 hours preoperatively, then 3 times daily | 10 Days | pe, dvt by 125I-labelled fibrinogen scan, venography to 4 weeks | 0 | 2.5 | >0.05 | 5.1 | 2.5 | >0.05 |
| Von Tempelhoff et al., 1997 22 | 60 | lmwh 3000 IU daily | ufh 5000 IU 3 times daily | 7 Days | pe on scintigraphy, by impedance dvt plethysmography, venography, up to day 30 | 6.7 | 0 | >0.05 | Not assessed | ||
| Heilmann et al., 1998 23 | 324 | Certoparin 3000 IU daily | ufh 5000 IU 3 times daily | 7 Days | dvt by impedance plethysmography, venography up to day 10 | 6.3 | 6.1 | 1.0 | 16.8 | 28.7 | 0.01 |
vte = venous thromboembolism; lmwh = low molecular weight heparin; ufh = unfractionated heparin; pe = pulmonary embolism; dvt = deep vein thrombosis.