Evidence map›Paper›PMID 34518968›Full record

Trial reportNeurocritical care2022

Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: A Multicenter Randomized Clinical Trial.

Georgene W Hergenroeder, Shoji Yokobori, Huimahn Alex Choi, Karl Schmitt, Michelle A Detry, Lisa H Schmitt, Anna McGlothlin, Ava M Puccio, Jonathan Jagid, Yasuhiro Kuroda and 15 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurocritical care, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 14 institutions in 2 countries.

Georgene W Hergenroeder *The Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA. Georgene.W.Hergenroeder@uth.tmc.edu.ORCID 0000-0002-6170-2191
Shoji Yokobori *Department of Emergency and Critical Care Medicine, Nippon Medical School Hospital, Tokyo, Japan.
Huimahn Alex ChoiThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Karl SchmittThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Michelle A DetryStatistical and Software Team, Berry Consultants, Austin, TX, USA.
Lisa H SchmittThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Anna McGlothlinStatistical and Software Team, Berry Consultants, Austin, TX, USA.
Ava M PuccioDepartment of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Jonathan JagidDepartment of Neurological Surgery, Jackson Memorial Hospital, University of Miami, Miami, FL, USA.
Yasuhiro KurodaDepartment of Emergency, Disaster, and Critical Care Medicine, Kagawa University Hospital, Kagawa Prefecture, Japan.
Yukihiko NakamuraEmergency and Critical Care Medicine, Kurume University Hospital, Fukuoka, Japan.
Eiichi SuehiroDepartment of Neurosurgery, Yamaguchi University Hospital, Yamaguchi, Japan.
Faiz AhmadDepartment of Neurological Surgery, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, GA, USA.
Kert VieleStatistical and Software Team, Berry Consultants, Austin, TX, USA.
Elisabeth A WildeH. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.
Stephen R McCauleyH. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.
Ryan S KitagawaThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Nancy R TemkinDepartments of Neurological Surgery and Biostatistics, University of Washington, Seattle, WA, USA.
Shelly D TimmonsDepartment of Neurological Surgery, Indiana University Health, Indiana University School of Medicine, Indianapolis, IN, USA.
Michael N DiringerDepartments of Neurology, Neurological Surgery, Anesthesiology, and Occupational Therapy, Washington University School of Medicine, St. Louis, MO, USA.
Pramod K DashThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Ross BullockDepartment of Neurological Surgery, Jackson Memorial Hospital, University of Miami, Miami, FL, USA.
David O OkonkwoDepartment of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Donald A BerryStatistical and Software Team, Berry Consultants, Austin, TX, USA.
Dong H KimThe Vivian L. Smith Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 7.156, Houston, TX, 77030, USA.
Memorial Hermann · USBerry & Associates (United States) · USBaylor College of Medicine · USUniversity of Miami · USUniversity of Pittsburgh Medical Center · USGrady Memorial Hospital · USIndiana University Health · USKagawa University Hospital · JPKurume University Hospital · JPNeurological Surgery · USNippon Medical School Hospital · JPThe University of Texas Health Science Center at Houston · USUniversity of Washington · USYamaguchi University Hospital · JP

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
UT Southwestern Center for Translational Medicine (UL1/KL2/TL1)UL1TR001105 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$24.5M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR001105
6 · The paper itself

Abstract

backgroundHypothermia is neuroprotective in some ischemia-reperfusion injuries. Ischemia-reperfusion injury may occur with traumatic subdural hematoma (SDH). This study aimed to determine whether early induction and maintenance of hypothermia in patients with acute SDH would lead to decreased ischemia-reperfusion injury and improve global neurologic outcome.

methodsThis international, multicenter randomized controlled trial enrolled adult patients with SDH requiring evacuation of hematoma within 6 h of injury. The intervention was controlled temperature management of hypothermia to 35 °C prior to dura opening followed by 33 °C for 48 h compared with normothermia (37 °C). Investigators randomly assigned patients at a 1:1 ratio between hypothermia and normothermia. Blinded evaluators assessed outcome using a 6-month Glasgow Outcome Scale Extended score. Investigators measured circulating glial fibrillary acidic protein and ubiquitin C-terminal hydrolase L1 levels.

resultsIndependent statisticians performed an interim analysis of 31 patients to assess the predictive probability of success and the Data and Safety Monitoring Board recommended the early termination of the study because of futility. Thirty-two patients, 16 per arm, were analyzed. Favorable 6-month Glasgow Outcome Scale Extended outcomes were not statistically significantly different between hypothermia vs. normothermia groups (6 of 16, 38% vs. 4 of 16, 25%; odds ratio 1.8 [95% confidence interval 0.39 to ∞], p = .35). Plasma levels of glial fibrillary acidic protein (p = .036), but not ubiquitin C-terminal hydrolase L1 (p = .26), were lower in the patients with favorable outcome compared with those with unfavorable outcome, but differences were not identified by temperature group. Adverse events were similar between groups.

conclusionsThis trial of hypothermia after acute SDH evacuation was terminated because of a low predictive probability of meeting the study objectives. There was no statistically significant difference in functional outcome identified between temperature groups.

Indexed as

Hematoma, Subdural, AcuteHypothermiaHypothermia, InducedReperfusion InjuryAdultGlial Fibrillary Acidic ProteinHematoma, SubduralHumansGlial Fibrillary Acidic ProteinBrain injuries (traumatic)Hematoma (subdural)Hypothermia (induced)

Identifiers

PMID34518968
PMCPMC8964656
OpenAlexW3199296226

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.