Evidence map›Paper›PMID 25072112›Full record

ArticleNeurosurgery2014

Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage.

Nestor R Gonzalez, Mark Connolly, Joshua R Dusick, Harshal Bhakta, Paul Vespa

3 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in Neurosurgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
–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.

NCT01158508 phase1completednot on this map

Prophylactic Remote Ischemic Preconditioning for Cerebral Vasospasm Following Subarachnoid Hemorrhage

TypeinterventionalSponsorUniversity of California, Los AngelesRan2010 to 2014Enrolled20ConditionsSubarachnoid Hemorrhage, Aneurysmal, Subarachnoid Hemorrhage, Cerebral Vasospasm, Intracranial AneurysmArmsRemote ischemic preconditioning
NCT02808754 nacompletednot on this mapstarted 2016, after this paper: background citation

Remote Ischemic Preconditioning for Carotid Endarterectomy

TypeinterventionalSponsorUniversity of PittsburghRan2016 to 2019Enrolled86ConditionsCarotid Stenosis, Endarterectomy, CarotidArmsRemote Ischemic Preconditioning
NCT06032533 narecruitingnot on this mapstarted 2023, after this paper: background citation

The Effect of Remote Ischemic Conditioning on Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Randomized, Patient-assessor Blinded, Sham-controlled Pilot Study Investigating Effect on Clinical Outcome.

TypeinterventionalSponsorAarhus University HospitalRan2023 to 2027Enrolled100ConditionsSubarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral IschemiaArmsRemote Ischemic Conditioning with Automatic Tourniquet Device, Sham Remote Ischemic Conditioning with Automatic Tourniquet Device
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Remote ischemic conditioning for stroke: A critical systematic review.International journal of stroke : official journal of the International Stroke Society · 2024
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  15. Conditioning-based therapeutics for aneurysmal subarachnoid hemorrhage - A critical review.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2024
    Review
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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

5 authors.

Nestor R GonzalezDepartment of Neurosurgery, David Geffen School of Medicine at the University of California, Los Angeles, California.
Mark Connolly
Joshua R Dusick
Harshal Bhakta
Paul Vespa

Funding

Surgical Indirect Revascularization For Symptomatic Intracranial Aterial StenosisK23NS079477 · NINDS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI GONZALEZ, NESTOR RAUL · 2013 to 2017
$842k
NINDS NIH HHS K23 NS079477NINDS NIH HHS K23NS079477
6 · The paper itself

Abstract

backgroundRemote ischemic conditioning (RIC) is a powerful endogenous mechanism whereby a sublethal ischemic stimulus confers a protective benefit against a subsequent severe ischemic insult. RIC has significant potential clinical implications for the prevention of delayed ischemic neurological deficit after aneurysmal subarachnoid hemorrhage (aSAH). Although RIC has been extensively investigated in animal models, it has not been fully evaluated in humans.

objectiveTo assess the feasibility and safety of RIC for aSAH in a phase I clinical trial.

methodsConsecutive patients hospitalized for treatment of an aSAH who met the inclusion/exclusion criteria were approached for consent. Enrolled patients received up to 4 RIC sessions on nonconsecutive days. Primary end points were the development of a symptomatic deep venous thrombosis, bruising, or injury to the limb and request to stop by the patient or surrogate. The secondary end points were the development of new neurological deficits or cerebral infarct, demonstrated by brain imaging after enrollment, and neurological deficit and condition at follow-up.

resultsTwenty patients were enrolled and underwent 76 RIC sessions, 75 of which were completed successfully. One session was discontinued when the patient became confused. No patient developed a deep venous thrombosis or injury to the preconditioned limb. No patient developed delayed ischemic neurological deficit during enrollment. At follow-up, median modified Rankin Scale score was 1 and Glasgow Outcome Scale score was 5.

conclusionThe RIC procedure was well tolerated and did not cause any injury. RIC for aSAH warrants investigation in a subsequent pivotal clinical trial.

Indexed as

AdultAgedBrainFeasibility StudiesFemaleGlasgow Outcome ScaleHumansIschemic PreconditioningMaleMiddle AgedSubarachnoid HemorrhageYoung Adult

Identifiers

PMID25072112
PMCPMC4205274

What OpenQuestion holds

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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.