Trial Information

Studio Pilota Farmacocinetico-clinico Sulla Somministrazione di Eparina a Basso Peso Molecolare e Dosaggio Sierico di HGF Nelle Pazienti Operate Affette da Patologie Ginecologiche

The study consisted of two phases. In the first phase, the main HGF pharmacokinetic
parameters were evaluated, comparing a group of six women treated with a single dose of
calcic nadroparin to a control group of six untreated women. Venous blood was drawn in both
groups at 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, 480 and 720 min. In the second phase,
the HGF basal and maximum concentrations were measured in 17 women, undergoing one month of
calcic nadroparin daily treatment. Venous blood was drawn twice on day 1 (at 0 and 90 min
after nadroparin administration), then once on days 8 and 28 (at 90 min after LMWH
injection). Calcic nadroparin was given subcutaneously at 2850 IU/0.3 ml anti-Xa.

Patients' characteristics:

In the first phase, 12 patients were enrolled, 6 treated with nadroparin for prophylactic
anticoagulation and another 6 untreated as the control group. The six nadroparin-group
patients were affected by benign pelvic gynaecologic diseases: three requiring laparoscopy
and three laparotomy.

In the control group, four were healthy women volunteers and two patients submitted to
gynaecological pelvic surgery, but these women were not treated with prophylactic LMWH.

In the second phase, 17 patients were enrolled among women planning gynaecological pelvic
surgery and treated for 4 weeks with nadroparin for prophylactic anticoagulation. All these
patients underwent laparotomy; ten were affected by malignancy (ECOC) and seven by benign
(uterine fibroma, ovarian cystadenoma) pelvic gynaecologic diseases.