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| Name | Class |
|---|---|
| University of Turin, Italy | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC | HGF serum concentration | 1 hour after nadroparin administration |
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Inclusion Criteria:
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:
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primary care clinic gynecological patients (benign diseases, oncological diseases)
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Zola, MD | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASO Ordine Mauriziano | Turin | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22999213 | Derived | 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. |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D010051 | Ovarian Neoplasms |
| D014565 | Urogenital Neoplasms |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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Serum
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D052801 | Male Urogenital Diseases |