Status:
COMPLETED
Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Collaborating Sponsors:
University of Turin, Italy
Conditions:
Genital Diseases, Female
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
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 contr...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01523652
Start Date
November 1 2007
End Date
November 1 2008
Last Update
February 1 2012
Active Locations (1)
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1
ASO Ordine Mauriziano
Turin, Italy