Evidence map›Paper›PMID 27834742›Full record

Trial reportStroke2016

Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2).

Patrick Lyden, Thomas Hemmen, James Grotta, Karen Rapp, Karin Ernstrom, Teresa Rzesiewicz, Stephanie Parker, Mauricio Concha, Syed Hussain, Sachin Agarwal and 5 more

4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stroke, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 79 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 6 pooled it
15.7field-weighted citation impact, top 1% 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.

NCT01123161 phase2 / phase3terminatednot on this map

Phase 2/3 Study of Intravenous Thrombolysis and Hypothermia for Acute Treatment of Ischemic Stroke

TypeinterventionalSponsorUniversity of California, San DiegoRan2010 to 2015Enrolled120ConditionsStroke, AcuteArmshypothermia and anti-shivering treatment, Group1: IV t-PA and normothermia
NCT05676957 naunknown statusnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized-controlled Trial to Assess the Safety and Efficacy of Intravascular Hypothermia in Acute Ischemia Stroke Patients With Recanalization After Thrombectomy

TypeinterventionalSponsorLiping LiuRan2023 to 2024Enrolled30ConditionsIschemic Stroke, Revascularization, Endovascular Treatment, Reperfusion InjuryArmsThermogard XP3
NCT06956521 phase1not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke

TypeinterventionalSponsorBaylor College of MedicineRan2025 to 2026Enrolled30ConditionsAcute Ischemic StrokeArmsMagnesium sulfate
NCT07096687 narecruitingnot on this mapstarted 2025, after this paper: background citation

Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot Trial

TypeinterventionalSponsorAzienda Usl di BolognaRan2025 to 2027Enrolled22ConditionsIschemic StrokeArmsTargeted Temperature Management with CB240_Aurora, Standard of care Temperature treatment
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 6 syntheses or guidelines pooled it, 167 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
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  10. Trial
  11. Review
  12. Article
  13. Temperature control in acute brain injury.Intensive care medicine · 2026
    Review
  14. Target temperature management in acute ischemic stroke.Frontiers in molecular biosciences · 2026
    Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article

19 more citing papers are in PubMed but not listed here.

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

15 authors at 20 institutions in 11 countries.

Patrick LydenFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.). lydenp@cshs.org.
Thomas HemmenFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
James GrottaFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Karen RappFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Karin ErnstromFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Teresa RzesiewiczFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Stephanie ParkerFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Mauricio ConchaFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Syed HussainFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Sachin AgarwalFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Brett MeyerFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Julie JurfFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Irfan AltafullahFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Rema RamanFrom the Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (P.L.); Department of Neurosciences (T.H., K.R., B.M.) and Sanford Stem Cell Clinical Center (T.R.), University of California, San Diego; Department of Neurology, Memorial Health Care System, Houston, TX (J.G.); Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego (K.E., R.R.); Department of Neurology, University of Texas McGovern Medical School, Houston (S.P.); Department of Neurosciences, Sarasota Memorial Health Care System, FL (M.C.); Department of Neurology, Michigan State University, Kalamazoo (S.H.); Department of Neurology, Columbia University, New York, NY (S.A.); Performance Improvement Patient Safety Department, UC San Diego Health System, CA (J.J.); and Department of Neurology, North Memorial Medical Center, Minneapolis, MN (I.A.).
Collaborators
University of Southern California · USColumbia University · USHartford Hospital · USUniversity of Miami · USScripps Mercy Hospital · USHoag Memorial Hospital Presbyterian · USUniversity of California San Diego · USAbington Memorial Hospital · USHenry Ford Hospital · USInnsbruck Medical University · ATNorth Memorial Medical Center · USUniversity of Alabama · USYale New Haven Hospital · USBruce Technologies (United States) · USCedars-Sinai Medical Center · USHess (United States) · USMichigan State University · USSaint Louis University · USSarasota Memorial Hospital · USUniversity of Colorado Denver · US

Funding

University of Texas Specialized Program in Acute StrokeP50NS044227 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI RAHBAR, MOHAMMAD HOSSEIN · 2002 to 2012
$17.9M
UltrasoundP50NS044148 · NINDS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MEYER, BRETT C · 2003 to 2012
$15.1M
NINDS NIH HHS P50 NS044148NINDS NIH HHS P50 NS044227
6 · The paper itself

Abstract

background and purposeTherapeutic hypothermia is a potent neuroprotectant approved for cerebral protection after neonatal hypoxia-ischemia and cardiac arrest. Therapeutic hypothermia for acute ischemic stroke is safe and feasible in pilot trials. We designed a study protocol to provide safer, faster therapeutic hypothermia in stroke patients.

methodsSafety procedures and 4°C saline infusions for faster cooling were added to the ICTuS trial (Intravascular Cooling in the Treatment of Stroke) protocol. A femoral venous intravascular cooling catheter after intravenous recombinant tissue-type plasminogen activator in eligible patients provided 24 hours cooling followed by a 12-hour rewarm. Serial safety assessments and imaging were performed. The primary end point was 3-month modified Rankin score 0,1.

resultsOf the intended 1600 subjects, 120 were enrolled before the study was stopped. Randomly, 63 were to receive hypothermia plus antishivering treatment and 57 normothermia. Compared with previous studies, cooling rates were improved with a cold saline bolus, without fluid overload. The intention-to-treat primary outcome of 90-day modified Rankin Score 0,1 occurred in 33% hypothermia and 38% normothermia subjects, odds ratio (95% confidence interval) of 0.81 (0.36-1.85). Serious adverse events occurred equally. Mortality was 15.9% hypothermia and 8.8% normothermia subjects, odds ratio (95% confidence interval) of 1.95 (0.56-7.79). Pneumonia occurred in 19% hypothermia versus 10.5% in normothermia subjects, odds ratio (95% confidence interval) of 1.99 (0.63-6.98).

conclusionsIntravascular therapeutic hypothermia was confirmed to be safe and feasible in recombinant tissue-type plasminogen activator-treated acute ischemic stroke patients. Protocol changes designed to reduce pneumonia risk appeared to fail, although the sample is small. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01123161.

Indexed as

Outcome Assessment, Health CareAgedAged, 80 and overFemaleFollow-Up StudiesHumansHypothermia, InducedMaleMiddle AgedSingle-Blind MethodStrokehypothermiaintention to treat analysisischemic strokeneuroprotectionpneumoniastroketherapeutics

Identifiers

PMID27834742
PMCPMC5134910
OpenAlexW2550224805

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.