Clinical trial NCT01523652: Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients
Official title: Studio Pilota Farmacocinetico-clinico Sulla Somministrazione di Eparina a Basso Peso Molecolare e Dosaggio Sierico di HGF Nelle Pazienti Operate Affette da Patologie Ginecologiche
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Diseases, Female
Ovarian Neoplasms
Urogenital Neoplasms
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
First posted: 2012-02-01
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic gynecological patients (benign diseases, oncological diseases)

Brief summary: The purpose of this study is to determine whether HGF serum concentration might be raised in vivo by administering nadroparin given with prophylactic purpose to gynecological patients.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC
timeFrame: 1 hour after nadroparin administration
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: ASO Ordine Mauriziano
Study officials:
affiliation: University of Turin, Italy
name: Paolo Zola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Surbone A, Fuso L, Passera R, Ferrero A, Marchese C, Martino C, Luchin A, Di Renzo MF, Zola P. Daily administration of low molecular weight heparin increases Hepatocyte Growth Factor serum levels in gynaecological patients: pharmacokinetic parameters and clinical implications. BMC Res Notes. 2012 Sep 23;5:517. doi: 10.1186/1756-0500-5-517.