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

This study has been completed.
Sponsor:
Collaborator:
University of Turin, Italy
Information provided by (Responsible Party):
Paolo Zola, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT01523652
First received: July 5, 2011
Last updated: January 30, 2012
Last verified: January 2012

July 5, 2011
January 30, 2012
November 2007
Not Provided
AUC [ Time Frame: 1 hour after nadroparin administration ] [ Designated as safety issue: No ]
HGF serum concentration
Same as current
Complete list of historical versions of study NCT01523652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients
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 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

primary care clinic gynecological patients (benign diseases, oncological diseases)

  • Genital Diseases, Female
  • Ovarian Neoplasms
  • Urogenital Neoplasms
Not Provided
  • Nadroparin/control (phase 1)
    patients affected by benign pelvic gynaecologic diseases were enrolled and treated with nadroparin for prophylactic anticoagulation; patients untreated with nadroparin were as control group.
  • Nadroparin (phase 2)
    patients were enrolled among women planning gynaecological pelvic surgery and treated for 4 weeks with nadroparin for prophylactic anticoagulation. All these patients underwent laparotomy;
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
November 2008
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01523652
FRFUnito60_07
No
Paolo Zola, Azienda Ospedaliera San Giovanni Battista
Azienda Ospedaliera San Giovanni Battista
University of Turin, Italy
Principal Investigator: Paolo Zola, MD University of Turin
Azienda Ospedaliera San Giovanni Battista
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP