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Trials
Published in: Trials 1/2022

01-12-2022 | Subdural Hematoma | Study protocol

Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design

Authors: Ranjit D. Singh, Jeroen T. J. M. van Dijck, Thomas A. van Essen, Hester F. Lingsma, Suzanne S. Polinder, Erwin J. O. Kompanje, Erik W. van Zwet, Ewout W. Steyerberg, Godard C. W. de Ruiter, Bart Depreitere, Wilco C. Peul

Published in: Trials | Issue 1/2022

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Abstract

Background

The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH

Methods

In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024.

Discussion

The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered.

Trial registration

Nederlands Trial Register (NTR), Trial NL9012. ClinicalTrials.gov, Trial NCT04648436.
Literature
1.
Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, et al. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017;16(12):987–1048.CrossRefPubMed
2.
Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, et al. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Heal. 2016;1(2):e76–83.
3.
Benedetto N, Gambacciani C, Montemurro N, Morganti R, Perrini P. Surgical management of acute subdural haematomas in elderly: report of a single center experience. Brit J Neurosurg. 2016;31(2):1–5.
4.
Peeters W, Majdan M, Brazinova A, Nieboer D, Maas AIR. Changing epidemiological patterns in traumatic brain injury: a longitudinal hospital-based study in Belgium. Neuroepidemiology. 2017;48(1–2):63–70.PubMed
5.
Scholten AC, Haagsma JA, Panneman MJM, van Beeck EF, Polinder S. Traumatic brain injury in the Netherlands: incidence, costs and disability-adjusted life years. Plos One. 2014;9(10):e110905.PubMedPubMedCentral
6.
Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, et al. Epidemiology of traumatic brain injury in Europe: a living systematic review. J Neurotraum. 2021;38(10):1411–40.
7.
Peeters W, van den Brande R, Polinder S, Brazinova A, Steyerberg EW, Lingsma HF, et al. Epidemiology of traumatic brain injury in Europe. Acta Neurochir. 2015;157(10):1683–96.PubMed
8.
Harvey LA, Close JCT. Traumatic brain injury in older adults: characteristics, causes and consequences. Injury. 2012;43(11):1821–6.PubMed
9.
Maxeiner H. Entstehungsbedingungen, Quellen und Typologie von tödlichen Subduralblutungen. Rechtsmedizin. 1998;9:14–20.
10.
Mak CHK, Wong SKH, Wong GK, Ng S, Wang KKW, Lam PK, et al. Traumatic brain injury in the elderly: is it as bad as we think? Curr Transl Geriatr Exp Gerontol Rep. 2012;1(3):171–8.PubMedPubMedCentral
11.
Howard MA, Gross AS, Dacey RG, Winn HR. Acute subdural hematomas: an age-dependent clinical entity. J Neurosurg. 1989;71(6):858–63.PubMed
12.
Borkar SA, Sinha S, Agrawal D, Satyarthee GD, Gupta D, Mahapatra AK. Severe head injury in the elderly: risk factor assessment and outcome analysis in a series of 100 consecutive patients at a Level 1 trauma centre. Indian J Neurotrauma. 2011;08(02):77–82.
13.
Won S-Y, Dubinski D, Brawanski N, Strzelczyk A, Seifert V, Freiman TM, et al. Significant increase in acute subdural hematoma in octo- and nonagenarians: surgical treatment, functional outcome, and predictors in this patient cohort. Neurosurg Focus. 2017;43(5):E10.PubMed
14.
Cagetti B, Cossu M, Pau A, Rivano C, Viale G. The outcome from acute subdural and epidural intracranial haematomas in very elderly patients. Brit J Neurosurg. 2009;6(3):227–31.
15.
Karibe H, Hayashi T, Hirano T, Kameyama M, Nakagawa A, Tominaga T. Surgical management of traumatic acute subdural hematoma in adults: a review. Neurol Med-chir. 2014;54(11):887–94.
16.
Unterhofer C, Hartmann S, Freyschlag CF, Thomé C, Ortler M. Severe head injury in very old patients: to treat or not to treat? Results of an online questionnaire for neurosurgeons. Neurosurg Rev. 2018;41(1):183–7.PubMed
17.
Raj R, Mikkonen ED, Kivisaari R, Skrifvars MB, Korja M, Siironen J. Mortality in elderly patients operated for an acute subdural hematoma: a surgical case series. World Neurosurg. 2016;88:592–7.PubMed
18.
van Essen T, de Ruiter G, den Boogert H, Volovici V, Maas A, Peul W. Neurochirurgische dilemma’s bij traumatisch hersenletsel. Tijdschrift voor Neurologie en Neurochirurgie (TNN). 2018;2(119):46–51.
19.
Bonis PD, Pompucci A, Mangiola A, Paternoster G, Festa R, Nucci CG, et al. Decompressive craniectomy for elderly patients with traumatic brain injury: it’s probably not worth the while. J Neurotraum. 2011;28(10):2043–8.
20.
Honeybul S, Gillett G, Ho K, Lind C. Ethical considerations for performing decompressive craniectomy as a life-saving intervention for severe traumatic brain injury. J Med Ethics. 2012;38(11):657.PubMed
21.
Tallon JM, Ackroyd-Stolarz S, Karim SA, Clarke DB. The epidemiology of surgically treated acute subdural and epidural hematomas in patients with head injuries: a population-based study. Can J Surg J Can De Chir. 2008;51(5):339–45.
22.
Nijboer JMM, van der Naalt J, ten Duis H-J. Patients beyond salvation? Various categories of trauma patients with a minimal Glasgow Coma Score. Injury. 2010;41(1):52–7.PubMed
23.
Mathew P, Oluoch-Olunya DL, Condon BR, Bullock R. Acute subdural haematoma in the conscious patient: outcome with initial non-operative management. Acta Neurochir. 1993;121(3–4):100–8.PubMed
24.
Servadei F, Nasi MT, Cremonini AM, Giuliani G, Cenni P, Nanni A. Importance of a reliable admission Glasgow Coma Scale Score for determining the need for evacuation of posttraumatic subdural hematomas. J Trauma Inj Infect Crit Care. 1998;44(5):868–73.
25.
Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, et al. Surgical management of acute subdural hematomas. Neurosurgery. 2006;58(3Suppl):S16–24.PubMed
26.
Wong CW. Criteria for conservative treatment of supratentorial acute subdural haematomas. Acta Neurochir. 1995;135(1–2):38–43.PubMed
27.
Rayan N, Barnes S, Fleming N, Kudyakov R, Ballard D, Gentilello LM, et al. Barriers to compliance with evidence-based care in trauma. J Trauma Acute Care Surg. 2012;72(3):585–93.PubMed
28.
Cnossen MC, Scholten AC, Lingsma HF, Synnot A, Tavender E, Gantner D, et al. Adherence to guidelines in adult patients with traumatic brain injury: a living systematic review. J Neurotraum. 2021;38(8):1072–85.
29.
van Essen TA, de Ruiter GCW, Kho KH, Peul WC. Neurosurgical treatment variation of traumatic brain injury: evaluation of acute subdural hematoma management in Belgium and The Netherlands. J Neurotraum. 2017;34(4):881–9.
30.
van Essen TA, Dijkman MD, Cnossen MC, Moudrous W, Ardon H, Schoonman GG, et al. Comparative effectiveness of surgery for traumatic acute subdural hematoma in an aging population. J Neurotraum. 2019;36(7):1184–91.
31.
van Essen TA, den Boogert HF, Cnossen MC, de Ruiter GCW, Haitsma I, Polinder S, et al. Variation in neurosurgical management of traumatic brain injury: a survey in 68 centers participating in the CENTER-TBI study. Acta Neurochir. 2019;161(3):435–49.PubMed
32.
Cnossen MC, Polinder S, Andriessen TM, van der Naalt J, Haitsma I, Horn J, et al. Causes and consequences of treatment variation in moderate and severe traumatic brain injury. Crit Care Med. 2017;45(4):660–9.PubMed
33.
Lingsma HF, Roozenbeek B, Li B, Lu J, Weir J, Butcher I, et al. Large between-center differences in outcome after moderate and severe traumatic brain injury in the International Mission on Prognosis and Clinical Trial Design in Traumatic Brain Injury (IMPACT) Study. Neurosurgery. 2011;68(3):601–8.PubMed
34.
Lingsma HF, Roozenbeek B, Perel P, Roberts I, Maas AI, Steyerberg EW. Between-centre differences and treatment effects in randomized controlled trials: a case study in traumatic brain injury. Trials. 2011;12(1):201.PubMedPubMedCentral
35.
Carney N, Totten AM, O’Reilly C, Ullman JS, Hawryluk GWJ, Bell MJ, et al. Guidelines for the Management of Severe Traumatic Brain Injury. 4th Edition. Neurosurgery. 2017;80(1):6–15.PubMed
36.
Turgeon AF, Lauzier F, Burns KEA, Meade MO, Scales DC, Zarychanski R, et al. Determination of neurologic prognosis and clinical decision making in adult patients with severe traumatic brain injury. Crit Care Med. 2013;41(4):1086–93.PubMed
37.
38.
Brazinova A, Mauritz W, Leitgeb J, Wilbacher I, Majdan M, Janciak I, et al. Outcomes of patients with severe traumatic brain injury who have Glasgow Coma Scale Scores of 3 or 4 and are over 65 years old. J Neurotraum. 2010;27(9):1549–55.
39.
Gressot LV, Chamoun RB, Patel AJ, Valadka AB, Suki D, Robertson CS, et al. Predictors of outcome in civilians with gunshot wounds to the head upon presentation. J Neurosurg. 2014;121(3):645–52.PubMed
40.
van Dijck JT, Reith FC, van Erp IA, van Essen TA, Maas AI, Peul WC, et al. Decision making in very severe traumatic brain injury (Glasgow Coma Scale 3-5): a literature review of acute neurosurgical management. J Neurosurg Sci. 2017;62(2):153–77.PubMed
41.
Mulligan P, Raore B, Liu S, Olson J. Neurological and functional outcomes of subdural hematoma evacuation in patients over 70 years of age. J Neurosci Rural Pract. 2013;04(03):250–6.
42.
van Eijsden P. Beslissen over opereren bij acuut subduraal hematoom. Ned Tijdschr Genees. 2017;161(0):D1661.
43.
Hanif S, Abodunde O, Ali Z, Pidgeon C. Age related outcome in acute subdural haematoma following traumatic head injury. Irish Med J. 2009;102(8):255–7.
44.
Herou E, Romner B, Tomasevic G. Acute traumatic brain injury: mortality in the elderly. World Neurosurg. 2015;83(6):996–1001.PubMed
45.
Taussky P, Hidalgo ET, Landolt H, Fandino J. Age and salvageability: analysis of outcome of patients older than 65 years undergoing craniotomy for acute traumatic subdural hematoma. World Neurosurg. 2012;78(3–4):306–11.PubMed
46.
Shimoda K, Maeda T, Tado M, Yoshino A, Katayama Y, Bullock MR. Outcome and surgical management for geriatric traumatic brain injury: analysis of 888 cases registered in the Japan Neurotrauma Data Bank. World Neurosurg. 2014;82(6):1300–6.PubMed
47.
Wutzler S, Lefering R, Wafaisade A, Maegele M, Lustenberger T, Walcher F, et al. Aggressive operative treatment of isolated blunt traumatic brain injury in the elderly is associated with favourable outcome. Injury. 2015;46(9):1706–11.PubMed
48.
Lee K-S, Shim J-J, Yoon S-M, Oh J-S, Bae H-G, Doh J-W. Surgical decision making for the elderly patients in severe head injuries. J Korean Neurosurg S. 2014;55(4):195–9.
49.
Bajsarowicz P, Prakash I, Lamoureux J, Saluja RS, Feyz M, Maleki M, et al. Nonsurgical acute traumatic subdural hematoma: what is the risk? J Neurosurg. 2015;123(5):1176–83.PubMed
50.
Hutchinson P, Kolias A, Timofeev I, Corteen E, Czosnyka M, Timothy J, et al. Trial of decompressive craniectomy for traumatic intracranial hypertension. New Engl J Med. 2016;375(12):1119–30.PubMed
51.
Ghajar JM, Hariri RJM, Narayan RKM, Iacono LAR, Firlik KB, Patterson RHM. Survey of critical care management of comatose, head-injured patients in the United States. Crit Care Med. 1995;23(3):560–7.PubMed
52.
53.
Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? New Engl J Med. 2009;360(19):1925–7.PubMed
54.
Gernsback JE, Kolcun JPG, Richardson AM, Jagid JR. Patientem Fortuna Adiuvat: the delayed treatment of surgical acute subdural hematomas-a case series. World Neurosurg. 2018;120:e414–20.PubMed
55.
Compagnone C, Murray GD, Teasdale GM, Maas AIR, Esposito D, Princi P, et al. The management of patients with intradural post-traumatic mass lesions: a multicenter survey of current approaches to surgical management in 729 patients coordinated by the European Brain Injury Consortium. Neurosurgery. 2005;57(6):1183–92.PubMed
56.
Smith GCS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003;327(7429):1459.PubMedPubMedCentral
57.
Mendelow AD, Gregson BA, Rowan EN, Francis R, McColl E, McNamee P, et al. Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial. J Neurotraum. 2015;32(17):1312–23.
58.
Olesen J, Gustavsson A, Svensson M, Wittchen H-U, Jönsson B, group C study, et al. The economic cost of brain disorders in Europe: economic cost of brain disorders in Europe. Eur J Neurol. 2011;19(1):155–62.
59.
van Dijck JTJM, van Essen TA, Dijkman MD, Mostert CQB, Polinder S, Peul WC, et al. Functional and patient-reported outcome versus in-hospital costs after traumatic acute subdural hematoma (t-ASDH): a neurosurgical paradox? Acta Neurochir. 2019;161(5):875–84.PubMed
60.
Whitmore RG, Thawani JP, Grady MS, Levine JM, Sanborn MR, Stein SC. Is aggressive treatment of traumatic brain injury cost-effective? J Neurosurg. 2012;116(5):1106–13.PubMed
61.
Braithwaite RS, Meltzer DO, King JT, Leslie D, Roberts MS. What does the value of modern medicine say about the $50,000 per quality-adjusted life-year decision rule? Med Care. 2008;46(4):349–56.PubMed
62.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.PubMed
63.
Dal-Ré R, Janiaud P, Ioannidis JPA. Real-world evidence: how pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018;16(1):49.PubMedPubMedCentral
64.
Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JAH, Tans JTJ, et al. Surgery versus prolonged conservative treatment for sciatica. New Engl J Med. 2007;356(22):2245–56.PubMed
65.
Miah IP, Holl DC, Peul WC, Walchenbach R, Kruyt N, de Laat K, et al. Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial. Trials. 2018;19(1):575.PubMedPubMedCentral
66.
Loftis KL, Price J, Gillich PJ. Evolution of the Abbreviated Injury Scale: 1990-2015. Traffic Inj Prev. 2018;19(sup2):1–5.
67.
DGU T, Bayer J, Lefering R, Reinhardt S, Kühle J, Südkamp NP, et al. Severity-dependent differences in early management of thoracic trauma in severely injured patients - analysis based on the TraumaRegister DGU®. Scand J Trauma Resusc Emerg Med. 2017;25(1):10.
68.
Wright DW, Clark PL, Pentz RD, Hertzberg V, Kellermann AL. Enrolling subjects by exception from consent versus proxy consent in trauma care research. Ann Emerg Med. 2008;51(4):355–360.e3.PubMed
69.
Boone M, Oren-Grinberg A, Robinson T, Chen C, Kasper E. Mannitol or hypertonic saline in the setting of traumatic brain injury: what have we learned? Surg Neurol Int. 2015;6(1):177.PubMedPubMedCentral
70.
Kompanje EJO, van Dijck JTJM, Chalos V, van den Berg SA, Janssen PM, Nederkoorn PJ, et al. Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke. Lancet Neurol. 2020;19(12):1033–42.PubMed
71.
Kompanje E. Uitgestelde toestemming voor inclusie van beslissingsonbekwame patiënten in studies van spoedeisende geneeskunde. Ned Tijdschr Geneesk. 2008;152:2057–61.
72.
Cooper DJ, Rosenfeld JV, Murray L, Arabi YM, Davies AR, D’Urso P, et al. Decompressive craniectomy in diffuse traumatic brain injury. New Engl J Med. 2011;364(16):1493–502.PubMed
73.
Gregson BA, Rowan EN, Francis R, McNamee P, Boyers D, Mitchell P, et al. Surgical Trial In Traumatic intraCerebral Haemorrhage (STITCH): a randomised controlled trial of Early Surgery compared with Initial Conservative Treatment. Health Technol Asses. 2015;19(70):1–138.
74.
Weir J, Steyerberg EW, Butcher I, Lu J, Lingsma HF, McHugh GS, et al. Does the Extended Glasgow Outcome Scale add value to the Conventional Glasgow Outcome Scale? J Neurotraum. 2012;29(1):53–8.
75.
Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, et al. Recommendations for the use of common outcome measures in traumatic brain injury research. Arch Phys Med Rehab. 2010;91(11):1650–1660.e17.
76.
Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the Extended Glasgow Outcome Scale: guidelines for their use. J Neurotraum. 1998;15(8):573–85.
77.
Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet Lond Engl. 1975;1(7905):480–4.
78.
Pettigrew LEL, Wilson JTL, Teasdale GM. Reliability of ratings on the Glasgow Outcome Scales from in-person and telephone structured interviews. J Head Trauma Rehab. 2003;18(3):252–8.
79.
Wilson JTL, Edwards P, Fiddes H, Stewart E, Teasdale GM. Reliability of Postal Questionnaires for the Glasgow Outcome Scale. J Neurotraum. 2002;19(9):999–1005.
80.
Shukla D, Devi BI, Agrawal A. Outcome measures for traumatic brain injury. Clin Neurol Neurosur. 2011;113(6):435–41.
81.
Bullock MR, Merchant RE, Choi SC, Gilman CB, Kreutzer JS, Marmarou A, et al. Outcome measures for clinical trials in neurotrauma. Neurosurg Focus. 2002;13(1):1–11.
82.
von Steinbuechel N, Petersen C, Bullinger M, Group Q. Assessment of health-related quality of life in persons after traumatic brain injury--development of the Qolibri, a specific measure. Acta Neurochir Suppl. 2005;93:43–9.
83.
von Steinbüchel N, Wilson L, Gibbons H, Hawthorne G, Höfer S, Schmidt S, et al. Quality of Life after Brain Injury (QOLIBRI): Scale Development and Metric Properties. J Neurotraum. 2010;27(7):1167–85.
84.
von Steinbüchel N, Wilson L, Gibbons H, Hawthorne G, Höfer S, Schmidt S, et al. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotraum. 2010;27(7):1157–65.
85.
Group TE. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.
86.
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool For Mild Cognitive Impairment. J Am Geriatr Soc. 2005;53(4):695–9.PubMed
87.
Maas AIR, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, et al. Standardizing data collection in traumatic brain injury. J Neurotraum. 2011;28(2):177–87.
88.
Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, et al. Common data elements for traumatic brain injury: recommendations from the interagency working group on demographics and clinical assessment. Arch Phys Med Rehab. 2010;91(11):1641–9.
89.
Senn S, Julious S. Measurement in clinical trials: a neglected issue for statisticians? Stat Med. 2009;28(26):3189–209.PubMed
90.
Roozenbeek B, Lingsma HF, Perel P, Edwards P, Roberts I, Murray GD, et al. The added value of ordinal analysis in clinical trials: an example in traumatic brain injury. Crit Care. 2011;15(3):R127.PubMedPubMedCentral
91.
Malmivaara K. The quality of life and cost-effectiveness of treatment after a serious neurosurgical illness. Helsinki: 2014. p. 74.
92.
Roijen NH, Bouwmans C, Kanters T, Tan S. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg. 2015. p. 1–120.
93.
Thiry N, Neyt M, Sande SVD, Cleemput I. Belgian guidelines for economic evaluations: second edition. Int J Technol Assess. 2014;30(6):601–7.
94.
ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med. 1999;18(15):1905–42.
95.
Knops AM, Legemate DA, Goossens A, Bossuyt PMM, Ubbink DT. Decision aids for patients facing a surgical treatment decision. Ann Surg. 2013;257(5):860–6.PubMed
96.
97.
van Dijck JTJM, Dijkman MD, Ophuis RH, de Ruiter GCW, Peul WC, Polinder S. In-hospital costs after severe traumatic brain injury: a systematic review and quality assessment. Plos One. 2019;14(5):e0216743.PubMedPubMedCentral
Metadata
Title
Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design
Authors
Ranjit D. Singh
Jeroen T. J. M. van Dijck
Thomas A. van Essen
Hester F. Lingsma
Suzanne S. Polinder
Erwin J. O. Kompanje
Erik W. van Zwet
Ewout W. Steyerberg
Godard C. W. de Ruiter
Bart Depreitere
Wilco C. Peul
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06184-1

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