Effect of pre-operative Simvastatin use on fibrinolytic activity during surgery. A randomized clinical pilot study

Effect of pre-operative Simvastatin use on fibrinolytic activity during surgery. A randomized clinical pilot study - Effect of Simvastatin on fibrinolytic activity during surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38347

Enrollment

Registered

2010-07-23

Start date

2011-07-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adhesions

Interventions

Test-group will receive 1dd 80 mg simvastatin, control-group will receive 1dd 80 mg placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. Especially, as a measure of fibrinolytic activity we will measure the concentration of FMs (fibrin monomers) in proportion to FbDPs (fibrin degradation products) at several postoperative time points. Primary study end-points : * change in CRP plasma level form study entry to surgery * peak plasma level of CRP after surgery * area under curve of postoperative CRP levels in plasma * tPA concentration in plasma at surgery * tPA activity in plasma at surgery * tPA concentration in peritoneal fluid at surgery * tPA activity in peritoneal fluid at surgery	—

Measure

Time frame

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. Especially, as a measure of fibrinolytic activity we will measure the concentration of FM*s (fibrin monomers) in proportion to FbDP*s (fibrin degradation products) at several postoperative time points. Primary study end-points : * change in CRP plasma level form study entry to surgery * peak plasma level of CRP after surgery * area under curve of postoperative CRP levels in plasma * tPA concentration in plasma at surgery * tPA activity in plasma at surgery * tPA concentration in peritoneal fluid at surgery * tPA activity in peritoneal fluid at surgery

—

Secondary

Measure	Time frame
Secondary study end-points : * Peak level in plasma of distribution FM / FbDPs Area under curve of postoperative distribution FM / FbDP*s in plasma	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)