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
  Purpose

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.


Condition
Genital Diseases, Female
Ovarian Neoplasms
Urogenital Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • AUC [ Time Frame: 1 hour after nadroparin administration ] [ Designated as safety issue: No ]
    HGF serum concentration


Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 29
Study Start Date: November 2007
Study Completion Date: November 2008
Groups/Cohorts
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;

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523652

Locations
Italy
ASO Ordine Mauriziano
Turin, Italy
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
University of Turin, Italy
Investigators
Principal Investigator: Paolo Zola, MD University of Turin
  More Information

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Zola, Prof Paolo Zola, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT01523652     History of Changes
Other Study ID Numbers: FRFUnito60_07
Study First Received: July 5, 2011
Last Updated: January 30, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Neoplasms
Genital Diseases, Female
Ovarian Neoplasms
Urogenital Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014