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

18 Years
Not Enrolling
Genital Diseases, Female, Ovarian Neoplasms, Urogenital Neoplasms

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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.

Inclusion Criteria:

- ≥ 18 years

- ECOG PS ≤ 1

- Neutrophils ≥ 1500 l -1, platelets ≥ 150,000 l -1, creatinine 0.6 to 1.2 mg dl -1,
total bilirubin ≤ 1 mg dL -1, AST ≤ 35 U l-1, ALT ≤ 45 U l-1

For patients in the study group: high-moderate risk of deep vein thrombosis (for the
administration of LMWH for 30 days after surgery) under general anesthesia> 30 minutes,
laparoscopy + at least one risk factor (age> 40 years, obesity, varicose veins, previous
episode of deep vein thrombosis and / or pulmonary thromboembolism, thrombophilia,
malignancy, prolonged immobility, congestive heart failure)

Exclusion Criteria:

- severe liver and renal disease

- diabetes

- hyperlipidemia

- marked osteoporosis

- HIV infection

- ongoing treatment with: immunosuppressive therapies, contraceptives, lipid-lowering
drugs, NSAIDs, antiplatelet drugs, recent acute inflammatory or infectious (<3 weeks)

- a history of allergies,

- drug possible confounding, caffeine, tobacco, ethanol (must not have been hired in
the last 24 hours prior to sampling)

- high risk of bleeding: peptic ulcer, history of hemorrhagic stroke, or bleeding
disorders, severe hypertension, cerebral aneurysms, arteriovenous malformations,
brain metastases

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

HGF serum concentration

Outcome Time Frame:

1 hour after nadroparin administration

Safety Issue:


Principal Investigator

Paolo Zola, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Turin


Italy: Ethics Committee

Study ID:




Start Date:

November 2007

Completion Date:

November 2008

Related Keywords:

  • Genital Diseases, Female
  • Ovarian Neoplasms
  • Urogenital Neoplasms
  • Neoplasms
  • Genital Diseases, Female
  • Ovarian Neoplasms
  • Urogenital Neoplasms