Evidence map›Paper›PMID 22267829›Full record

ArticleStroke2012

The Albumin in Subarachnoid Hemorrhage (ALISAH) multicenter pilot clinical trial: safety and neurologic outcomes.

Jose I Suarez, Renee H Martin, Eusebia Calvillo, Catherine Dillon, Eric M Bershad, R Loch Macdonald, John Wong, Robert Harbaugh, ALISAH Investigators

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Stroke, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00283400 (Treatment of Subarachnoid Hemorrhage With Human Albumin), which is not on this map. Cited by 61 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT00283400 naterminatednot on this map

Treatment of Subarachnoid Hemorrhage With Human Albumin

TypeinterventionalSponsorBaylor College of MedicineRan2006 to 2011Enrolled47ConditionsSubarachnoid HemorrhageArms25% human albumin
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 2 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
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  17. Impact of human serum albumin level on symptomatic cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  18. Observational
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  20. Review

1 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

9 authors at 3 institutions in 2 countries.

Jose I SuarezDepartment of Neurology, Baylor College of Medicine, 6501 Fannin Street, NB 302, Houston, TX 77030, USA. jisuarez@bcm.edu
Renee H Martin
Eusebia Calvillo
Catherine Dillon
Eric M Bershad
R Loch Macdonald
John Wong
Robert Harbaugh
ALISAH Investigators
Medical University of South Carolina · USUniversity of Toronto · CAUniversity of Calgary · CA

Funding

Treatment of Subarachnoid Hemorrhage with Human AlbuminR01NS049135 · NINDS · CASE WESTERN RESERVE UNIVERSITY · PI SUAREZ, JOSE I · 2006 to 2010
$1.4M
NINDS NIH HHS NS049135NINDS NIH HHS R01 NS049135
6 · The paper itself

Abstract

background and purposeHuman albumin has been shown to exert neuroprotective effects in animal models of cerebral ischemia and humans with various intracranial pathologies. We investigated the safety and tolerability of 25% human albumin in patients with subarachnoid hemorrhage.

methodsThe Albumin in Subarachnoid Hemorrhage (ALISAH) Pilot Clinical Trial was an open-label, dose-escalation study. We intended to study 4 different dosages of albumin of increasing magnitude (0.625 g/kg: Tier 1; 1.25 g/kg: Tier 2; 1.875 g/kg: Tier 3; and 2.5 g/kg: Tier 4). Each dosage was to be given to 20 adult patients. Treatment was administered daily for 7 days. We investigated the maximum tolerated dose of albumin based on the rate of severe-to-life-threatening heart failure and anaphylactic reaction and functional outcome at 3 months.

resultsWe treated 47 adult subjects: 20 in Tier 1; 20 in Tier 2; and 7 in Tier 3. We found that doses ranging up to 1.25 g/kg/day×7 days were tolerated by patients without major dose-limiting complications. We also found that outcomes trended toward better responses in those subjects enrolled in Tier 2 compared with Tier 1 (OR, 3.0513; CI, 0.6586-14.1367) and with the International Intraoperative Hypothermia for Aneurysm Surgery Trial cohort (OR, 3.1462; CI, 0.9158-10.8089).

conclusionsAlbumin in doses ranging up to 1.25 g/kg/day×7 days was tolerated by patients with subarachnoid hemorrhage without major complications and may be neuroprotective. Based on these results, planning of the ALISAH II, a Phase III, randomized, placebo-controlled trial to test the efficacy of albumin, is underway. CLINICAL

trial registrationURL: http://clinicaltrials.gov. Unique identifier: NCT00283400.

Indexed as

Acute DiseaseAdultAgedAlbuminsBlood PressureCardiovascular DiseasesData Interpretation, StatisticalDisability EvaluationDose-Response Relationship, DrugFemaleFollow-Up StudiesGlasgow Outcome ScaleHumansMaleMiddle AgedNervous System DiseasesAlbuminsNeuroprotective Agents

Identifiers

PMID22267829
PMCPMC3288646
OpenAlexW2119356332

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.