Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage
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- Stefan Wolf
- Department of Neurosurgery, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Dorothee Mielke
- Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany
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- Christoph Barner
- Department of Anesthesiology, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Vesna Malinova
- Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany
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- Thomas Kerz
- Department of Neurosurgery, University Medical Center, Johannes Gutenberg University, Mainz, Germany
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- Maria Wostrack
- Department of Neurosurgery, Technical University Munich, Munich, Germany
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- Patrick Czorlich
- Department of Neurosurgery, Hamburg University Medical Center, Hamburg, Germany
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- Farid Salih
- Department of Neurology, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Doortje C. Engel
- Department of Neurosurgery, Cantonal Hospital St Gallen, St Gallen, Switzerland
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- Angelika Ehlert
- Department of Neurosurgery, Asklepios Hospital St Georg, Hamburg, Germany
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- Dimitre Staykov
- Department of Neurology, University Medical Center Erlangen-Nuremberg, Erlangen, Germany
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- Abdulrahman Y. Alturki
- Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University, Montreal, Quebec, Canada
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- Ulrich Sure
- Department of Neurosurgery and Spine Surgery, University Hospital Essen, Essen, Germany
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- Jürgen Bardutzky
- Department of Neurology, University Medical Center Erlangen-Nuremberg, Erlangen, Germany
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- Henry W. S. Schroeder
- Department of Neurosurgery, University Medicine Greifswald, Greifswald, Germany
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- Ludwig Schürer
- Department of Neurosurgery, Klinikum Bogenhausen, Technical University Munich, Munich, Germany
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- Jürgen Beck
- Department of Neurosurgery, University of Freiburg, Freiburg, Germany
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- Tareq A. Juratli
- Department of Neurosurgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
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- Michael Fritsch
- Department of Neurosurgery, Dietrich Bonhoeffer Klinikum, Neubrandenburg, Germany
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- Johannes Lemcke
- Department of Neurosurgery, Unfallkrankenhaus Berlin, Berlin, Germany
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- Anne Pohrt
- Department of Medical Biometrics, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Bernhard Meyer
- Department of Neurosurgery, Technical University Munich, Munich, Germany
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- Stefan Schwab
- Department of Neurology, University Medical Center Erlangen-Nuremberg, Erlangen, Germany
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- Veit Rohde
- Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany
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- Peter Vajkoczy
- Department of Neurosurgery, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
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- Norbert Baro
- for the EARLYDRAIN Study Group
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- Miriam Bauer
- for the EARLYDRAIN Study Group
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- Nora F. Dengler
- for the EARLYDRAIN Study Group
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- Falk von Dincklage
- for the EARLYDRAIN Study Group
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- Tobias Finger
- for the EARLYDRAIN Study Group
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- Roland Francis
- for the EARLYDRAIN Study Group
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- Benjamin Hotter
- for the EARLYDRAIN Study Group
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- Oliver Hunsicker
- for the EARLYDRAIN Study Group
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- Daniel Jussen
- for the EARLYDRAIN Study Group
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- Eric Jüttler
- for the EARLYDRAIN Study Group
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- Andreas Schaumann
- for the EARLYDRAIN Study Group
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- Jens Witsch
- for the EARLYDRAIN Study Group
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- Christoph Nagel
- for the EARLYDRAIN Study Group
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- Ullrich Meier
- for the EARLYDRAIN Study Group
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- Dino Podlesik
- for the EARLYDRAIN Study Group
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- Gabriele Schackert
- for the EARLYDRAIN Study Group
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- Hagen Huttner
- for the EARLYDRAIN Study Group
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- Sabine Hagedorn
- for the EARLYDRAIN Study Group
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- Daniela Müller
- for the EARLYDRAIN Study Group
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- Oliver Müller
- for the EARLYDRAIN Study Group
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- Robert Sarge
- for the EARLYDRAIN Study Group
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- Wolf-Dirk Niesen
- for the EARLYDRAIN Study Group
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- Katharina Lange
- for the EARLYDRAIN Study Group
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- Dennis Päsler
- for the EARLYDRAIN Study Group
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- Stephanie Reinhardt
- for the EARLYDRAIN Study Group
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- Jan Regelsberger
- for the EARLYDRAIN Study Group
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- Thomas Sauvigny
- for the EARLYDRAIN Study Group
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- Manfred Westphal
- for the EARLYDRAIN Study Group
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- Rudolf Gremmer
- for the EARLYDRAIN Study Group
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- Christian Beyer
- for the EARLYDRAIN Study Group
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- Desiree Beyer
- for the EARLYDRAIN Study Group
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- Alexandra Huthmann
- for the EARLYDRAIN Study Group
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- Julia Landscheidt
- for the EARLYDRAIN Study Group
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- David B. Schul
- for the EARLYDRAIN Study Group
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- Yu-Mi Ryang
- for the EARLYDRAIN Study Group
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- Elisabeth Toeroek
- for the EARLYDRAIN Study Group
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- Wasim Arouk
- for the EARLYDRAIN Study Group
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- Hosam Al-Jehani
- for the EARLYDRAIN Study Group
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- David B. Sinclair
- for the EARLYDRAIN Study Group
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- Christian Fung
- for the EARLYDRAIN Study Group
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- Nicole Soell
- for the EARLYDRAIN Study Group
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- Gerhard Hildebrandt
- for the EARLYDRAIN Study Group
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- Karen Huscher
- for the EARLYDRAIN Study Group
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- Heidrun Lange
- for the EARLYDRAIN Study Group
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- Peter Hutchinson
- for the EARLYDRAIN Study Group
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- Ming-Yuan Tseng
- for the EARLYDRAIN Study Group
Bibliographic Information
- Other Title
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- A Randomized Clinical Trial
Abstract
<jats:sec><jats:title>Importance</jats:title><jats:p>After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours.</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, −0.12; 95% CI, −0.23 to −0.01; <jats:italic>P</jats:italic> = .04). Patients treated with a lumbar drain had fewer secondary infarctions at discharge (41 patients [28.5%] vs 57 patients [39.9%]; risk ratio, 0.71; 95% CI, 0.49 to 0.99; absolute risk difference, −0.11; 95% CI, −0.22 to 0; <jats:italic>P</jats:italic> = .04).</jats:p></jats:sec><jats:sec><jats:title>Conclusion and Relevance</jats:title><jats:p>In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01258257">NCT01258257</jats:ext-link></jats:p></jats:sec>
Journal
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- JAMA Neurology
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JAMA Neurology 80 (8), 833-, 2023-08-01
American Medical Association (AMA)
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Details 詳細情報について
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- CRID
- 1360017677208050944
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- ISSN
- 21686149
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- Data Source
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- Crossref