Donor Simvastatin Treatment in Organ Transplantation (SIMVA)
The aim of the study is to investigate the effects of simvastatin treatment on ischemia-reperfusion injury in the context of cardiac-, lung-, kidney-, and liver transplantation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
|Official Title:||Donor Simvastatin Treatment in Organ Transplantation|
- Preoperative donor simvastatin treatment reduces ischemia-reperfusion injury [ Time Frame: 0-20 years ] [ Designated as safety issue: Yes ]
- Preoperative donor simvastatin treatment reduces natural immune activity and the rate of rejection [ Time Frame: 0-20 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Simvastatin treatment group
The patients whose organ donor have received statin treatment prior transplantation
80 mg simvastatin through nasogastric tube prior organ harvesting
Sham Comparator: Control
The patients whose organ donor has not received statin treatment prior organ transplantation
The study hypothesis is that the per orally administered donor-related simvastatin treatment protects the transplanted organs for cold ischemia-related injury and ischemia-reperfusion injury. Also, it potentially decreases natural immune activity, rejection activation and thus improves long-term prognosis.
80 mg simvastatin is administered into donor circulation through the nasogastric tube 4-6 hours prior organ harvesting. The impact of donor simvastatin treatment is investigated and analyzed by several specific blood samples and biopsies that are taken from the recipient at the various time-points during the perioperative and postoperative phase. The randomized and blinded control group includes heart-, lung-, kidney-, and liver recipients whose organ donors have not received any statin medication prior organ harvesting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160978
|Helsinki University Hospital. Dept. of Cardiothoracic Surgery|
|Helsinki, Finland, FI-00029|
|Principal Investigator:||Janne J Jokinen, MD, PhD||Helsinki University Hospital, Dept. of Cardiothoracic Surgery|