Statins are able to significantly increase peritoneal fibrinolytic activity.
ID
Bron
Aandoening
hysterectomy with or without a unilateral or bilateral salpingooophorectomy per laparotomy for benigne pathology.
Ondersteuning
Haga Teaching Hospital, Department of Gynecology
Leyweg 275
2545 CH The Hague
0702100000
Haga Teaching Hospital, Department of Gynecology
Leyweg 275
2545 CH The Hague
0702100000
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Change in CRP plasma level from study entry to surgery;<br>
2. Peak plasma level of CRP after surgery;<br>
3. Area under curve of postoperative CRP levels in plasma;<br>
4. tPA concentration in plasma at surgery;<br>
5. tPA activity in plasma at surgery;<br>
6. tPA concentration in peritoneal fluid at surgery;<br>
7. tPA activity in peritoneal fluid at surgery.
Achtergrond van het onderzoek
Twenty patients, scheduled for an abdominal hysterectomy with or without a unilateral or bilateral salpingo-oophorectomy for benign pathology are included in this randomized clinical pilot study. Test patients will receive 80 mg Simvastatin per day, three weeks before surgery and one week thereafter, whereas the control patients will receive placebo before and after the surgical procedure. The ability to significantly increase peritoneal fibrinolytic activity will be assessed by comparing the fibrinolytic activity and concentrations of fibrinolytic parameters in peritoneal fluid and plasma in Simvastatin treated patients and controls.
Doel van het onderzoek
Statins are able to significantly increase peritoneal fibrinolytic activity.
Onderzoeksopzet
Blood samples:
I: - 4-8 weeks;
II: -3 weeks;
III: day of surgery;
IV: during surgery;
V: +3 hours;
VI: +6 hours;
VII: +1 day;
VIII: + 2 days;
IX: +3 days;
X: +1 week.
Onderzoeksproduct en/of interventie
Intervention: Simvastatine tablets, 80mg simvastatine a day, 3 weeks before and 1 week after surgery;
Control: Placebo.
Publiek
Haga Teaching Hospital, Department of Gynecology<br>
Leyweg 275
Marianne Hel, van der
Den Haag 2545 CH
The Netherlands
+31 (0)70 2106219
m.vanderhel@hagaziekenhuis.nl
Wetenschappelijk
Haga Teaching Hospital, Department of Gynecology<br>
Leyweg 275
Marianne Hel, van der
Den Haag 2545 CH
The Netherlands
+31 (0)70 2106219
m.vanderhel@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 18 years or older;
2. Scheduled for hysterectomy with or without a unilateral or bilateral salpingooophorectomy per laparotomy for benigne pathology;
3. Good general health with no significant systemic condition at baseline evaluation that would hinder proper outcome assessment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Non compliance with one or several inclusion criteria;
2. Pregnant women;
3. Haematologic or coagulation disorders;
4. Patient has been diagnosed with a carcinoma or is receiving cancer therapy, including anti-neoplastic drugs and radiation;
5. Patient is already on statin therapy;
6. Patients unavailible for the duration of the study;
7. Presence of ongoing pelvic infection, as for example, ovarian or tubal abscess;
8. Patients participating in another clinical trial
side effects on previous statin treatment;
9. CPK levels >1,5 times ULN at baseline assessment;
10. ALAT levels >1,5 times ULN at baseline assessment;
11. Concomitant liver disease;
12. Renal insufficiency >KDOKI stage III (cockroft formula);
13. Concomitant muscle disease;
14. Reumatological disorders;
15. Medication: CYP3A4-inhibitors as Ciclosporine, Itraconazol, Ketoconazol, Erytromycin, Claritromycin, HIV-protease inhibitors of grapefruit juice. Antimycotic azoolderivates or macrolide antibiotics and Gemfibrozil. Also other fibrates (PPAR-alpha), nicotine acid and fucidin acid, use of Gamma activators (Rosiglitazone, Pioglitazone, etc.) and use of anti-inflammatory agents in general.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3309 |
| NTR-old | NTR3456 |
| Ander register | METC : 10-018 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |