Ignite Creation Date:
2024-05-06 @ 12:14 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01523652
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2011-07-05
Brief Title:
Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Azienda Ospedaliera San Giovanni Battista
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 IU03 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None