Evidence map›Paper›PMID 35086362›Full record

Trial reportStroke2022

Intraventricular Hemorrhage Expansion in the CLEAR III Trial: A Post Hoc Exploratory Analysis.

David J Roh, Ifeyinwa S Asonye, Fernanda Carvalho Poyraz, Jessica R Magid-Bernstein, Evan F Joiner, Radhika Avadhani, Issam Awad, Daniel F Hanley, Wendy C Ziai, Santosh B Murthy

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00784134 (Clot Lysis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT00784134 phase3completednot on this map

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

TypeinterventionalSponsorJohns Hopkins UniversityRan2009 to 2016Enrolled500ConditionsIntraventricular HemorrhageArmsAlteplase, Normal saline
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  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

10 authors.

David J RohDepartment of Neurology (D.J.R., I.S.A., F.C.P.), Vagelos College of Physicians and Surgeons, Columbia University, NY.
Ifeyinwa S AsonyeDepartment of Neurology (D.J.R., I.S.A., F.C.P.), Vagelos College of Physicians and Surgeons, Columbia University, NY.
Fernanda Carvalho PoyrazDepartment of Neurology (D.J.R., I.S.A., F.C.P.), Vagelos College of Physicians and Surgeons, Columbia University, NY.ORCID 0000-0003-2488-6849
Jessica R Magid-BernsteinDivision of Neurocritical Care and Emergency Neurology, Department of Neurology, Yale University School of Medicine, New Haven, CT (J.R.M.-B.).ORCID 0000-0001-6506-6017
Evan F JoinerDepartment of Neurological Surgery (E.F.J.), Vagelos College of Physicians and Surgeons, Columbia University, NY.ORCID 0000-0002-7243-8779
Radhika AvadhaniBrain Injury Outcomes Division (R.A., D.F.H., W.C.Z.), Johns Hopkins University School of Medicine, Baltimore, MD.
Issam AwadDepartment of Neurological Surgery, University of Chicago School of Medicine, IL (I.A.).ORCID 0000-0003-1510-602X
Daniel F HanleyBrain Injury Outcomes Division (R.A., D.F.H., W.C.Z.), Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-9536-4258
Wendy C Ziai *Brain Injury Outcomes Division (R.A., D.F.H., W.C.Z.), Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4548-7353
Santosh B Murthy *Clinical and Translational Neuroscience Unit and Department of Neurology, Feil Family Brain and Mind Research Institute, Weill Cornell Medicine, NY (S.B.M.).ORCID 0000-0002-4950-0992

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
MISTIE III_ Lead Grant_ Cluster Application for the Clinical Coordinating CenterU01NS080824 · NINDS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2013 to 2017
$23.2M
Clot Lysis: Evaluating Accelerated Resolution of IVH Phase III (CLEAR III)U01NS062851 · NINDS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2009 to 2013
$21.6M
Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)U01NS106513 · NINDS · YALE UNIVERSITY · PI Hooman Kamel, Kevin Navin Sheth · 2019 to 2026
$20.6M
The Impact of Oxidative Stress on Erythocyte BiologyR01HL148151 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI D'ALESSANDRO, ANGELO, KARAFIN, MATTHEW S · 2019 to 2022
$8.9M
Microglia/macrophage polarization after intracerebral hemorrhageR01NS102583 · NINDS · JOHNS HOPKINS UNIVERSITY · PI KOEHLER, RAYMOND CHARLES · 2018 to 2021
$1.8M
Intracerebral Hemorrhage and Increased Risk of Arterial ThromboembolismK23NS105948 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI MURTHY, SANTOSH BHASKAR · 2018 to 2022
$972k
Erythrocyte contribution to coagulopathy and cerebral oxygenation after intracerebral hemorrhageK23HL151901 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ROH, DAVID · 2021 to 2025
$950k
NCATS NIH HHS U24 TR001609NCATS NIH HHS UL1 TR001863NHLBI NIH HHS K23 HL151901NHLBI NIH HHS R01 HL148151NINDS NIH HHS K23 NS105948NINDS NIH HHS R01 NS102583NINDS NIH HHS U01 NS062851NINDS NIH HHS U01 NS080824NINDS NIH HHS U01 NS106513
6 · The paper itself

Abstract

backgroundThe objective of this study was to evaluate factors associated with intraventricular hemorrhage (IVH) expansion and its association with long-term outcomes.

methodsWe performed a post hoc analysis of the international, multi-center CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) which enrolled IVH patients between September 1, 2009, and January 31, 2015. The exposure was IVH expansion, defined as >1 mL increase in volume between baseline and stability computed tomography scans, before treatment randomization. We assessed factors associated with IVH expansion and secondarily assessed the relationship of IVH expansion with clinical outcomes: composite of death or major disability (modified Rankin Scale score, >3), and mortality alone at 6 months. The relationship of IVH expansion on ventriculoperitoneal shunt placement was additionally explored. Multivariable logistic regression was used for all analyses.

resultsOf 500 IVH patients analyzed, the mean age was 59 (±11) years old, 44% were female and 135 (27%) had IVH expansion. In multivariable regression models, factors associated with IVH expansion were baseline parenchymal intracerebral hemorrhage (ICH) volume (adjusted odds ratio [OR], 1.04 per 1 mL increase [95% CI, 1.01-1.08]), presence of parenchymal hematoma expansion: >33% (adjusted OR, 6.63 [95% CI, 3.92-11.24]), time to stability head CT (adjusted OR, 0.71 per 1 hour increase [95% CI, 0.54-0.94]), and thalamic hematoma location (adjusted OR, 1.68 [95% CI, 1.01-2.79]) while additionally adjusting for age, sex, and race. In secondary analyses, IVH expansion was associated with higher odds of poor 6-month outcomes (adjusted OR, 1.84 [95% CI, 1.12-3.02]) but not mortality (OR, 1.40 [95% CI, 0.78-2.50]) after adjusting for baseline ICH volume, thalamic ICH location, age, anticoagulant use, Glasgow Coma Scale score, any withdrawal of care order, and treatment randomization arm. However, there were no relationships of IVH expansion on subsequent ventriculoperitoneal shunt placement (adjusted OR, 1.02 [95% CI, 0.58-1.80]) after adjusting for similar covariates.

conclusionsIn a clinical trial cohort of patients with large IVH, acute hematoma characteristics, specifically larger parenchymal volume, hematoma expansion, and thalamic ICH location were associated with IVH expansion. Given that IVH expansion resulted in poor functional outcomes, exploration of treatment approaches to optimize hemostasis and prevent IVH expansion, particularly in patients with thalamic ICH, require further study. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00784134.

Indexed as

Cerebral HemorrhageHematomaAgedFemaleHumansMaleMiddle AgedRisk FactorsThalamusTomography, X-Ray Computedcerebral hemorrhagehematomatissue-type plasminogen activatorventriculostomy

Identifiers

PMID35086362
PMCPMC9133068

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.