Projektets originale titel: Postoperativ 24 timers aktiv subperiostal drænage versus 24 timers passiv subdural drænage efter evakuering af kronisk subduralt hæmatom – et nationalt randomiseret kontrolleret studie
English title: Active 24 hours subperiostal vs. 24 hours passive subdural drainage following burr hole evacuation of chronic subdural hematoma (the SuperDura trial) – A nationwide randomized clinical non-inferiority trial.
Short title:
SUPERDURA trial (SUbPERiostal vs subDURAl drain placement)
Samarbejdspartnere
- Rares Miscov1, Thorbjørn Søren Rønn Jensen2, Mads Hjortdal Grønhøj3,4, Mette Haldrup5, Markus Harboe Olsen6, Anders Rosendal Korshøj5, Frantz Rom Poulsen3,4 Kåre Fugleholm2 and Carsten Reidies Bjarkam1.
- 1Aalborg University Hospital, Dept. of Neurosurgery, Hobrovej 18-22, DK-9000 Aalborg, Denmark.
2Rigshospitalet, Dept. of Neurosurgery, Inge Lehmanns vej 6, DK-2100 Copenhagen, Denmark.
3Odense University Hospital, Dept. of Neurosurgery, J.B. Winsløwsvej 4, DK-5000 Odense, Denmark.
4Department of Clinical Research and BRIDGE—Brain Research Inter-Disciplinary Guided Excellence, University of Southern Denmark, DK-5000 Odense, Denmark.
5Aarhus University Hospital, Dept. Of Neurosurgery, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus, Denmark.
6Department of Neuroanesthesiology, The neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Primære forsøgsansvarlige
Læge Rares Miscov og overlæge, professor, dr. med. Carsten Reidies Bjarkam, Neurokirurgisk Afdeling, Aalborg Universitetshospital.
Formål:
At teste hvorvidt 24 timers aktiv subperiostal drænage er non-inferiort til 24 timers passiv subdural drænage efter borhulsevakuering af kronisk subdural hæmatom i forhold til recidiv og mortalitet indenfor 90 dage postoperativt.
Planlagt inklusion:
Inklusion af samlet 500 patienter (250 i hver gruppe).
Status:
- Godkendt af Videnskabsetisk komité
Afventer opstart