Research output: Contribution to journal › Article › Academic › peer-review
Surgery versus conservative treatment for traumatic acute subdural haematoma : a prospective, multicentre, observational, comparative effectiveness study. / CENTER-TBI Collaboration Group.
In: The Lancet Neurology, Vol. 21, No. 7, 01.07.2022, p. 620-631.Research output: Contribution to journal › Article › Academic › peer-review
}
TY - JOUR
T1 - Surgery versus conservative treatment for traumatic acute subdural haematoma
T2 - a prospective, multicentre, observational, comparative effectiveness study
AU - van Essen, Thomas A.
AU - Lingsma, Hester F.
AU - Pisică, Dana
AU - Singh, Ranjit D.
AU - Volovici, Victor
AU - den Boogert, Hugo F.
AU - Younsi, Alexander
AU - Peppel, Lianne D.
AU - Heijenbrok-Kal, Majanka H.
AU - Ribbers, Gerard M.
AU - Walchenbach, Robert
AU - Menon, David K.
AU - Hutchinson, Peter
AU - Depreitere, Bart
AU - Steyerberg, Ewout W.
AU - Maas, Andrew I. R.
AU - de Ruiter, Godard C. W.
AU - Peul, Wilco C.
AU - CENTER-TBI Collaboration Group
AU - Åkerlund, Cecilia
AU - Amrein, Krisztina
AU - Andelic, Nada
AU - Andreassen, Lasse
AU - Anke, Audny
AU - Antoni, Anna
AU - Audibert, G. rard
AU - Azouvi, Philippe
AU - Azzolini, Maria Luisa
AU - Bartels, Ronald
AU - Barzó, P. l
AU - Beauvais, Romuald
AU - Beer, Ronny
AU - Bellander, Bo-Michael
AU - Belli, Antonio
AU - Benali, Habib
AU - Berardino, Maurizio
AU - Beretta, Luigi
AU - Blaabjerg, Morten
AU - Bragge, Peter
AU - Brazinova, Alexandra
AU - Brinck, Vibeke
AU - Brooker, Joanne
AU - Brorsson, Camilla
AU - Buki, Andras
AU - Bullinger, Monika
AU - Cabeleira, Manuel
AU - Caccioppola, Alessio
AU - Calappi, Emiliana
AU - Calvi, Maria Rosa
AU - Cameron, Peter
AU - Carbayo Lozano, Guillermo
AU - Carbonara, Marco
AU - Castaño-León, Ana M.
AU - Cavallo, Simona
AU - Chevallard, Giorgio
AU - Chieregato, Arturo
AU - Citerio, Giuseppe
AU - Clusmann, Hans
AU - Coburn, Mark Steven
AU - Coles, Jonathan
AU - Cooper, Jamie D.
AU - Correia, Marta
AU - Čović, Amra
AU - Curry, Nicola
AU - Czeiter, Endre
AU - Czosnyka, Marek
AU - Dahyot-Fizelier, Claire
AU - Dark, Paul
AU - Dawes, Helen
AU - de Keyser, V. ronique
AU - Degos, Vincent
AU - Della Corte, Francesco
AU - Đilvesi, Đula
AU - Dixit, Abhishek
AU - Donoghue, Emma
AU - Dreier, Jens
AU - Dulière, Guy-Loup
AU - Ercole, Ari
AU - Esser, Patrick
AU - Ezer, Erzsébet
AU - Fabricius, Martin
AU - Feigin, Valery L.
AU - Foks, Kelly
AU - Frisvold, Shirin
AU - Furmanov, Alex
AU - Gagliardo, Pablo
AU - Galanaud, Damien
AU - Gantner, Dashiell
AU - Gao, Guoyi
AU - George, Pradeep
AU - Ghuysen, Alexandre
AU - Giga, Lelde
AU - Glocker, Ben
AU - Golubović, Jagoš
AU - Gomez, Pedro A.
AU - Gratz, Johannes
AU - Gravesteijn, Benjamin
AU - Grossi, Francesca
AU - Gruen, Russell L.
AU - Gupta, Deepak
AU - Haagsma, Juanita A.
AU - Haitsma, Iain
AU - Helbok, Raimund
AU - Helseth, Eirik
AU - Horton, Lindsay
AU - Huijben, Jilske
AU - Jacobs, Bram
AU - Jankowski, Stefan
AU - Jarrett, Mike
AU - Jiang, Ji-yao
AU - Johnson, Faye
AU - Jones, Kelly
AU - Karan, Mladen
AU - Kolias, Angelos G.
AU - Kompanje, Erwin
AU - Kondziella, Daniel
AU - Kornaropoulos, Evgenios
AU - Koskinen, Lars-Owe
AU - Kovács, Noémi
AU - Lagares, Alfonso
AU - Lanyon, Linda
AU - Laureys, Steven
AU - Lecky, Fiona
AU - Ledoux, Didier
AU - Lefering, Rolf
AU - Legrand, Valerie
AU - Lejeune, Aurelie
AU - Levi, Leon
AU - Lightfoot, Roger
AU - Maegele, Marc
AU - Majdan, Marek
AU - Manara, Alex
AU - Manley, Geoffrey
AU - Maréchal, Hugues
AU - Martino, Costanza
AU - Mattern, Julia
AU - McMahon, Catherine
AU - Melegh, B. la
AU - Menovsky, Tomas
AU - Mikolic, Ana
AU - Misset, Benoit
AU - Muraleedharan, Visakh
AU - Murray, Lynnette
AU - Nair, Nandesh
AU - Negru, Ancuta
AU - Nelson, David
AU - Newcombe, Virginia
AU - Nieboer, Daan
AU - Nyirádi, J. zsef
AU - Oresic, Matej
AU - Ortolano, Fabrizio
AU - Otesile, Olubukola
AU - Palotie, Aarno
AU - Parizel, Paul M.
AU - Payen, Jean-François
AU - Perera, Natascha
AU - Perlbarg, Vincent
AU - Persona, Paolo
AU - Piippo-Karjalainen, Anna
AU - Pirinen, Matti
AU - Ples, Horia
AU - Polinder, Suzanne
AU - Pomposo, Inigo
AU - Posti, Jussi P.
AU - Puybasset, Louis
AU - Rădoi, Andreea
AU - Ragauskas, Arminas
AU - Raj, Rahul
AU - Rambadagalla, Malinka
AU - Rehorčíková, Veronika
AU - Retel Helmrich, Isabel
AU - Rhodes, Jonathan
AU - Richardson, Sylvia
AU - Richter, Sophie
AU - Ripatti, Samuli
AU - Rocka, Saulius
AU - Roe, Cecilie
AU - Roise, Olav
AU - Rosand, Jonathan
AU - Rosenfeld, Jeffrey
AU - Rosenlund, Christina
AU - Rosenthal, Guy
AU - Rossaint, Rolf
AU - Rossi, Sandra
AU - Rueckert, Daniel
AU - Rusnák, Martin
AU - Sahuquillo, Juan
AU - Sakowitz, Oliver
AU - Sanchez-Porras, Renan
AU - Sandor, Janos
AU - Schäfer, Nadine
AU - Schmidt, Silke
AU - Schoechl, Herbert
AU - Schoonman, Guus
AU - Schou, Rico Frederik
AU - Schwendenwein, Elisabeth
AU - Sewalt, Charlie
AU - Skandsen, Toril
AU - Smielewski, Peter
AU - Sorinola, Abayomi
AU - Stamatakis, Emmanuel
AU - Stanworth, Simon
AU - Kowark, Ana
AU - Stevens, Robert
AU - Stewart, William
AU - Stocchetti, Nino
AU - Sundström, Nina
AU - Takala, Riikka
AU - Tamás, Viktória
AU - Tamosuitis, Tomas
AU - Taylor, Mark Steven
AU - te Ao, Braden
AU - Tenovuo, Olli
AU - Theadom, Alice
AU - Thomas, Matt
AU - Tibboel, Dick
AU - Timmers, Marjolijn
AU - Tolias, Christos
AU - Trapani, Tony
AU - Tudora, Cristina Maria
AU - Unterberg, Andreas
AU - Vajkoczy, Peter
AU - Valeinis, Egils
AU - Vallance, Shirley
AU - Vámos, Zoltán
AU - van der Jagt, Mathieu
AU - van der Naalt, Joukje
AU - van der Steen, Gregory
AU - van Dijck, Jeroen T. J. M.
AU - van Hecke, Wim
AU - van Heugten, Caroline
AU - van Praag, Dominique
AU - van Veen, Ernest
AU - van Wijk, Roel
AU - Vande Vyvere, Thijs
AU - Vargiolu, Alessia
AU - Vega, Emmanuel
AU - Velt, Kimberley
AU - Verheyden, Jan
AU - Vespa, Paul M.
AU - Vik, Anne
AU - Vilcinis, Rimantas
AU - von Steinbüchel, Nicole
AU - Voormolen, Daphne
AU - Vulekovic, Petar
AU - Wang, Kevin K. W.
AU - Wiegers, Eveline
AU - Williams, Guy
AU - Wilson, Lindsay
AU - Winzeck, Stefan
AU - Wolf, Stefan
AU - Yang, Zhihui
AU - Ylén, Peter
AU - Zeiler, Frederick A.
AU - Ziverte, Agate
AU - Zoerle, Tommaso
N1 - Funding Information: The authors' work on this study is funded by the Hersenstichting Nederland (the Dutch Brain Foundation, grant number ps2014.06) for the Dutch Neurotraumatology Quality Registry 19 and the EU seventh Framework Programme (grant 602150) for CENTER-TBI. Additional support for CENTER-TBI was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from NeuroTrauma Sciences (USA). We thank all patients for their participation in the CENTER-TBI study; and all principal investigators and researchers for their collaboration and support. Funding Information: The authors' work on this study is funded by the Hersenstichting Nederland (the Dutch Brain Foundation, grant number ps2014.06) for the Dutch Neurotraumatology Quality Registry 19 and the EU seventh Framework Programme (grant 602150) for CENTER-TBI. Additional support for CENTER-TBI was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from NeuroTrauma Sciences (USA). We thank all patients for their participation in the CENTER-TBI study; and all principal investigators and researchers for their collaboration and support. Funding Information: AIRM declares consulting fees from PresSura Neuro, Integra Life Sciences, and NeuroTrauma Sciences. DKM reports grants from the UK National Institute for Health Research, during the conduct of the study; grants, personal fees, and non-financial support from GlaxoSmithKline; and personal fees from Neurotrauma Sciences, Lantmaanen AB, Pressura, and Pfizer, outside of the submitted work. EWS reports personal fees from Springer during the conduct of the study. All other authors declare no competing interests. Publisher Copyright: © 2022 Elsevier Ltd
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Background: Despite being well established, acute surgery in traumatic acute subdural haematoma is based on low-grade evidence. We aimed to compare the effectiveness of a strategy preferring acute surgical evacuation with one preferring initial conservative treatment in acute subdural haematoma. Methods: We did a prospective, observational, comparative effectiveness study using data from participants enrolled in the Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) cohort. We included patients with no pre-existing severe neurological disorders who presented with acute subdural haematoma within 24 h of traumatic brain injury. Using an instrumental variable analysis, we compared outcomes between centres according to treatment preference for acute subdural haematoma (acute surgical evacuation or initial conservative treatment), measured by the case-mix-adjusted percentage of acute surgery per centre. The primary endpoint was functional outcome at 6 months as rated with the Glasgow Outcome Scale Extended, which was estimated with ordinal regression as a common odds ratio (OR) and adjusted for prespecified confounders. Variation in centre preference was quantified with the median OR (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Findings: Between Dec 19, 2014 and Dec 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI, of whom 1407 (31%) presented with acute subdural haematoma and were included in our study. Acute surgical evacuation was done in 336 (24%) patients, by craniotomy in 245 (73%) of those patients and by decompressive craniectomy in 91 (27%). Delayed decompressive craniectomy or craniotomy after initial conservative treatment (n=982) occurred in 107 (11%) patients. The percentage of patients who underwent acute surgery ranged from 5·6% to 51·5% (IQR 12·3–35·9) between centres, with a two-times higher probability of receiving acute surgery for an identical patient in one centre versus another centre at random (adjusted MOR for acute surgery 1·8; p<0·0001]). Centre preference for acute surgery over initial conservative treatment was not associated with improvements in functional outcome (common OR per 23·6% [IQR increase] more acute surgery in a centre 0·92, 95% CI 0·77–1·09). Interpretation: Our findings show that treatment for patients with acute subdural haematoma with similar characteristics differed depending on the treating centre, because of variation in the preferred approach. A treatment strategy preferring an aggressive approach of acute surgical evacuation over initial conservative treatment was not associated with better functional outcome. Therefore, in a patient with acute subdural haematoma for whom a neurosurgeon sees no clear superiority for acute surgery over conservative treatment, initial conservative treatment might be considered. Funding: The Hersenstichting Nederland (also known as the Dutch Brain Foundation), the European Commission Seventh Framework Programme, the Hannelore Kohl Stiftung (Germany), OneMind (USA), Integra LifeSciences Corporation (USA), and NeuroTrauma Sciences (USA).
AB - Background: Despite being well established, acute surgery in traumatic acute subdural haematoma is based on low-grade evidence. We aimed to compare the effectiveness of a strategy preferring acute surgical evacuation with one preferring initial conservative treatment in acute subdural haematoma. Methods: We did a prospective, observational, comparative effectiveness study using data from participants enrolled in the Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) cohort. We included patients with no pre-existing severe neurological disorders who presented with acute subdural haematoma within 24 h of traumatic brain injury. Using an instrumental variable analysis, we compared outcomes between centres according to treatment preference for acute subdural haematoma (acute surgical evacuation or initial conservative treatment), measured by the case-mix-adjusted percentage of acute surgery per centre. The primary endpoint was functional outcome at 6 months as rated with the Glasgow Outcome Scale Extended, which was estimated with ordinal regression as a common odds ratio (OR) and adjusted for prespecified confounders. Variation in centre preference was quantified with the median OR (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Findings: Between Dec 19, 2014 and Dec 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI, of whom 1407 (31%) presented with acute subdural haematoma and were included in our study. Acute surgical evacuation was done in 336 (24%) patients, by craniotomy in 245 (73%) of those patients and by decompressive craniectomy in 91 (27%). Delayed decompressive craniectomy or craniotomy after initial conservative treatment (n=982) occurred in 107 (11%) patients. The percentage of patients who underwent acute surgery ranged from 5·6% to 51·5% (IQR 12·3–35·9) between centres, with a two-times higher probability of receiving acute surgery for an identical patient in one centre versus another centre at random (adjusted MOR for acute surgery 1·8; p<0·0001]). Centre preference for acute surgery over initial conservative treatment was not associated with improvements in functional outcome (common OR per 23·6% [IQR increase] more acute surgery in a centre 0·92, 95% CI 0·77–1·09). Interpretation: Our findings show that treatment for patients with acute subdural haematoma with similar characteristics differed depending on the treating centre, because of variation in the preferred approach. A treatment strategy preferring an aggressive approach of acute surgical evacuation over initial conservative treatment was not associated with better functional outcome. Therefore, in a patient with acute subdural haematoma for whom a neurosurgeon sees no clear superiority for acute surgery over conservative treatment, initial conservative treatment might be considered. Funding: The Hersenstichting Nederland (also known as the Dutch Brain Foundation), the European Commission Seventh Framework Programme, the Hannelore Kohl Stiftung (Germany), OneMind (USA), Integra LifeSciences Corporation (USA), and NeuroTrauma Sciences (USA).
UR - http://www.scopus.com/inward/record.url?scp=85132454217&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(22)00166-1
DO - 10.1016/S1474-4422(22)00166-1
M3 - Article
C2 - 35526554
VL - 21
SP - 620
EP - 631
JO - Lancet neurology
JF - Lancet neurology
SN - 1474-4422
IS - 7
ER -
ID: 25197425