Evidence map›Paper›PMID 37587492›Full record

ArticleTrials2023

Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial.

Chris A Rees, David C Brousseau, Daniel M Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E Chumpitazi, Gladstone Airewele, Todd Chang and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04839354 (Sickle Cell Disease Treatment With Arginine Therapy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
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.

NCT04839354 phase3completednot on this map

Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

TypeinterventionalSponsorClaudia R. MorrisRan2021 to 2024Enrolled271ConditionsSickle Cell DiseaseArmsL-Arginine Hydrochloride, Normal saline
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. 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 12 institutions in 1 country.

Chris A ReesDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Emory University School of Medicine, 1760 Haygood Drive NE, Atlanta, GA, W45830322, USA.ORCID http://orcid.org/0000-0001-6449-0377
David C BrousseauDepartment of Pediatrics, Nemours Children's Health Delaware and the Sidney Kimmel Medical College, Thomas Jefferson University, Wilmington, DE, USA.
Daniel M CohenNationwide Children's Hospital, Columbus, OH, USA.
Anthony VillellaNationwide Children's Hospital, Columbus, OH, USA.
Carlton DampierDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Emory University School of Medicine, 1760 Haygood Drive NE, Atlanta, GA, W45830322, USA.
Kathleen BrownChildren's National Hospital, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Andrew CampbellChildren's National Hospital, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Corrie E ChumpitaziTexas Children's Hospital and Baylor College of Medicine, Houston, TX, USA.
Gladstone AireweleTexas Children's Hospital and Baylor College of Medicine, Houston, TX, USA.
Todd ChangChildren's Hospital Los Angeles and Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Christopher DentonChildren's Hospital Los Angeles and Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Angela EllisonChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Alexis ThompsonChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Fahd AhmadWashington University in St. Louis, St. Louis, MO, USA.
Nitya BakshiDivision of Pediatric Hematology/Oncology/BMT, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.
Keli D ColemanMedical College of Wisconsin and Children's Wisconsin, Milwaukee, WI, USA.
Sara LeibovichUniversity of California, San Francisco, CA, USA.
Deborah LeakeChildren's Healthcare of Atlanta, Atlanta, GA, USA.
Dunia HatabahDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Emory University School of Medicine, 1760 Haygood Drive NE, Atlanta, GA, W45830322, USA.
Hagar WilkinsonChildren's Healthcare of Atlanta, Atlanta, GA, USA.
Michelle RobinsonUniversity of Utah School of Medicine, Salt Lake City, UT, USA.
T Charles CasperUniversity of Utah School of Medicine, Salt Lake City, UT, USA.
Elliott VichinskyCenter for Maternal-Fetal Precision Medicine, University of California, San Francisco, CA, USA.
Claudia R MorrisDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Emory University School of Medicine, 1760 Haygood Drive NE, Atlanta, GA, W45830322, USA. claudia.r.morris@emory.edu.
SCD Arginine Study Group and PECARN
Emory University · USBaylor College of Medicine · USChildren's Healthcare of Atlanta · USChildren's Hospital of Philadelphia · USGeorge Washington University · USNationwide Children's Hospital · USUniversity of California, San Francisco · USUniversity of Southern California · USUniversity of Utah · USChildren's Hospital of Wisconsin · USThomas Jefferson University · USWashington University in St. Louis · US

Funding

1/2 Sickel Cell Disease Treatment with Arginine Therapy (STArT Trial)UH3HL148560 · NHLBI · EMORY UNIVERSITY · PI MORRIS, CLAUDIA R · 2021 to 2025
$6.9M
2/2: Sickle Cell Disease Treatment with Arginine Therapy (STArT) trialU24HL148563 · NHLBI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI CASPER, THERON C · 2020 to 2025
$3.5M
Patient-Oriented Research in Arginine Deficiency SyndromesK24AT009893 · NCCIH · EMORY UNIVERSITY · PI Claudia R Morris · 2018 to 2026
$1.5M
STUDYING INTRA-INDIVIDUAL PAIN VARIABILITY IN SICKLE CELL DISEASE AND RESOLUTION OF PAIN AFTER HEMATOPOIETIC CELL TRANSPLANT: A NOVEL MODEL SYSTEM TO ELUCIDATE MECHANISMS OF TRANSITION TO CHRONIC PAINK23HL140142 · NHLBI · YALE UNIVERSITY · PI BAKSHI, NITYA · 2018 to 2022
$899k
NCCIH NIH HHS K24 AT009893NCCIH NIH HHS K24AT009893NHLBI NIH HHS 1K23HL140142NHLBI NIH HHS 5UH3HL148560NHLBI NIH HHS K23 HL140142NHLBI NIH HHS U24 HL148563NHLBI NIH HHS UH3 HL148560
6 · The paper itself

Abstract

backgroundDespite substantial illness burden and healthcare utilization conferred by pain from vaso-occlusive episodes (VOE) in children with sickle cell disease (SCD), disease-modifying therapies to effectively treat SCD-VOE are lacking. The aim of the Sickle Cell Disease Treatment with Arginine Therapy (STArT) Trial is to provide definitive evidence regarding the efficacy of intravenous arginine as a treatment for acute SCD-VOE among children, adolescents, and young adults.

methodsSTArT is a double-blind, placebo-controlled, randomized, phase 3, multicenter trial of intravenous arginine therapy in 360 children, adolescents, and young adults who present with SCD-VOE. The STArT Trial is being conducted at 10 sites in the USA through the Pediatric Emergency Care Applied Research Network (PECARN). Enrollment began in 2021 and will continue for 5 years. Within 12 h of receiving their first dose of intravenous opioids, enrolled participants are randomized 1:1 to receive either (1) a one-time loading dose of L-arginine (200 mg/kg with a maximum of 20 g) administered intravenously followed by a standard dose of 100 mg/kg (maximum 10 g) three times a day or (2) a one-time placebo loading dose of normal saline followed by normal saline three times per day at equivalent volumes and duration as the study drug. Participants, research staff, and investigators are blinded to the participant's randomization. All clinical care is provided in accordance with the institution-specific standard of care for SCD-VOE based on the 2014 National Heart, Lung, and Blood Institute guidelines. The primary outcome is time to SCD-VOE pain crisis resolution, defined as the time (in hours) from study drug delivery to the last dose of parenteral opioid delivery. Secondary outcomes include total parental opioid use and patient-reported outcomes. In addition, the trial will characterize alterations in the arginine metabolome and mitochondrial function in children with SCD-VOE. DISCUSSION: Building on the foundation of established relationships between emergency medicine providers and hematologists in a multicenter research network to ensure adequate participant accrual, the STArT Trial will provide definitive information about the efficacy of intravenous arginine for the treatment of SCD-VOE for children.

trial registrationThe STArT Trial was registered in ClinicalTrials.gov on April 9, 2021, and enrollment began on June 21, 2021 (NCT04839354).

Indexed as

Analgesics, OpioidAnemia, Sickle CellAcademies and InstitutesAdolescentArginineChildClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSaline SolutionYoung AdultAnalgesics, OpioidArginineSaline SolutionArginineRandomized controlled trialSickle cell diseaseVaso-occlusive pain

Identifiers

PMID37587492
PMCPMC10433602
OpenAlexW4385852526

What OpenQuestion holds

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LicenceCC BY
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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.