Effect of pre-operative Simvastatin use on fibrinolytic activity during surgery. A randomized clinical pilot study
- Conditions
- adhesions10029903
- Registration Number
- NL-OMON38347
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
18 years or older ; Patients are scheduled for hysterectomy with or without a unilateral or bilateral salpingo-oophorectomy (BSO) per laparotomy for benign pathology ; Patient is in good general health with no significant systemic conditions at baseline evaluation that would hinder proper outcome assessment.
Pregnant women ; Haematologic or coagulation disorders ; Patient has been diagnosed with a carcinoma or is receiving cancer therapy, including anti-neoplastic drugs and radiation ; Presence of ongoing pelvic infection as, for example, ovarian or tubal abscess ; Patients participating in any other clinical trial ; Side effects on previous statin treatment ; CPK levels>1.5 times ULN at baseline assessment ; ALAT levels > 1.5 times ULN at baseline assessment ; Concomitant liver disease ; Renal insufficiency > KDOKI stage III ; Concomitant muscle disease ; Reumatological disorders ; Medication: Fibrates (Gemfibrozil, PPAR-alpha), Gamma activators (Rosiglitazone, Pioglitazone, etc.) and use of anti-inflammatory agents in general.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The ability to significantly increase peritoneal fibrinolytic activity will be<br /><br>assessed by comparing the fibrinolytic activity and concentrations of<br /><br>fibrinolytic parameters in peritoneal fluid and plasma in Simvastatin treated<br /><br>patients and controls. Especially, as a measure of fibrinolytic activity we<br /><br>will measure the concentration of FM*s (fibrin monomers) in proportion to<br /><br>FbDP*s (fibrin degradation products) at several postoperative time points.<br /><br><br /><br>Primary study end-points :<br /><br><br /><br>* change in CRP plasma level form study entry to surgery<br /><br>* peak plasma level of CRP after surgery<br /><br>* area under curve of postoperative CRP levels in plasma<br /><br>* tPA concentration in plasma at surgery<br /><br>* tPA activity in plasma at surgery<br /><br>* tPA concentration in peritoneal fluid at surgery<br /><br>* tPA activity in peritoneal fluid at surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study end-points :<br /><br><br /><br>* Peak level in plasma of distribution FM / FbDP*s<br /><br>* Area under curve of postoperative distribution FM / FbDP*s in plasma</p><br>