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Effect of pre-operative Simvastatin use on fibrinolytic activity during surgery.


- candidate number12849
- NTR NumberNTR3456
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2012
- Secondary IDs10-018 METC
- Public TitleEffect of pre-operative Simvastatin use on fibrinolytic activity during surgery.
- Scientific TitleEffect of pre-operative Simvastatin use on fibrinolytic activity during surgery.
- ACRONYM
- hypothesisStatins are able to significantly increase peritoneal fibrinolytic activity.
- Healt Condition(s) or Problem(s) studiedHysterectomy, Simvastatin
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-okt-2011
- planned closingdate31-dec-2012
- Target number of participants20
- InterventionsIntervention: Simvastatine tablets, 80mg simvastatine a day, 3 weeks before and 1 week after surgery;
Control: Placebo.
- Primary outcome1. Change in CRP plasma level from study entry to surgery;
2. Peak plasma level of CRP after surgery;
3. Area under curve of postoperative CRP levels in plasma;
4. tPA concentration in plasma at surgery;
5. tPA activity in plasma at surgery;
6. tPA concentration in peritoneal fluid at surgery;
7. tPA activity in peritoneal fluid at surgery.
- Secondary outcome1. Peak level in plasma of distribution FM/FbDP's;
2. Area under curve of postoperative distribution FM/FbDP's in plasma.
- TimepointsBlood 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marianne Hel, van der
- CONTACT for SCIENTIFIC QUERIES Marianne Hel, van der
- Sponsor/Initiator Haga Teaching Hospital, Department of Gynecology
- Funding
(Source(s) of Monetary or Material Support)
Haga Teaching Hospital, Department of Gynecology
- PublicationsN/A
- Brief summaryTwenty 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.
- Main changes (audit trail)
- RECORD31-mei-2012 - 17-jun-2012


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