Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients

NCT01523652CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Azienda Ospedaliera San Giovanni Battista

Enrollment

29

Start Date

2007-11-01

Study Type

OBSERVATIONAL

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

Conditions

Genital DiseasesFemaleOvarian NeoplasmsUrogenital Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

AUC

HGF serum concentration

Time frame: 1 hour after nadroparin administration

Locations

ASO Ordine Mauriziano, Turin, Italy

Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients