Evidence map›Paper›PMID 34863258›Full record

ArticleTrials2021

Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI): study protocol for a randomized, placebo-controlled, multi-center trial.

Inge A M van Erp, Thomas A van Essen, Kees Fluiter, Erik van Zwet, Peter van Vliet, Frank Baas, Iain Haitsma, Dagmar Verbaan, Bert Coert, Godard C W de Ruiter and 3 more

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

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04489160 (A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT04489160 phase2unknown statusnot on this map

A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury

TypeinterventionalSponsorLeiden University Medical CenterRan2021 to 2024Enrolled106ConditionsTraumatic Brain Injury, Trauma, HeadArmsC1 Inhibitor, Human, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Interleukin-1 Receptor Antagonist as Therapy for Traumatic Brain Injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  6. Review
  7. Tackling Neuroinflammation After Traumatic Brain Injury: Complement Inhibition as a Therapy for Secondary Injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
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

13 authors at 3 institutions in 1 country.

Inge A M van ErpUniversity Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospital, Albinusdreef 2, J-11-R-83, 2333 ZA, Leiden, Hague, The Netherlands. i.a.m.van_erp@lumc.nl.ORCID http://orcid.org/0000-0003-3472-0367
Thomas A van EssenUniversity Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospital, Albinusdreef 2, J-11-R-83, 2333 ZA, Leiden, Hague, The Netherlands.
Kees FluiterDepartment of Clinical Genetics, Leiden University Medical Center, Leiden, The Netherlands.
Erik van ZwetDepartment of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands.
Peter van VlietDepartment of Intensive Care, Haaglanden Medical Center, The Hague, The Netherlands.
Frank BaasDepartment of Clinical Genetics, Leiden University Medical Center, Leiden, The Netherlands.
Iain HaitsmaDepartment of Neurosurgery, Erasmus MC - University Medical Center, Rotterdam, The Netherlands.
Dagmar VerbaanNeurosurgical Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Bert CoertNeurosurgical Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Godard C W de RuiterUniversity Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospital, Albinusdreef 2, J-11-R-83, 2333 ZA, Leiden, Hague, The Netherlands.
Wouter A MoojenUniversity Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospital, Albinusdreef 2, J-11-R-83, 2333 ZA, Leiden, Hague, The Netherlands.
Mathieu van der JagtDepartment of Intensive Care Adults, Erasmus MC - University Medical Center, Rotterdam, The Netherlands.
Wilco C PeulUniversity Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospital, Albinusdreef 2, J-11-R-83, 2333 ZA, Leiden, Hague, The Netherlands.
Leiden University Medical Center · NLErasmus MC · NLMedisch Centrum Haaglanden · NL

Funding

Hersenstichting DR-2019-00292Takeda Pharmaceuticals U.S.A. IIR-NLD-002790
6 · The paper itself

Abstract

backgroundTraumatic brain injury (TBI) is a major cause of death and disability across all ages. After the primary impact, the pathophysiologic process of secondary brain injury consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system could therefore be a therapeutic target in TBI.

objectiveTo study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI. By temporarily blocking the complement system, we hypothesize a decrease in the posttraumatic neuroinflammatory response resulting in a less unfavorable clinical outcome for TBI patients.

methodsCIAO@TBI is a multicenter, randomized, blinded, phase II placebo-controlled trial. Adult TBI patients with GCS < 13 requiring intracranial pressure (ICP) monitoring will be randomized, using block randomization, within 12 h after trauma to one dose 6000 IU C1-INH or placebo. A total of 106 patients will be included, and follow-up will occur up to 12 months. The primary endpoints are (1) Therapy Intensity Level (TIL) Scale, (2) Glasgow Outcome Scale-Extended (GOSE) at 6 months, and (3) complication rate during hospitalization. Outcomes will be determined by a trial nurse blinded for the treatment allocation. Analyses will be conducted in an intention-to-treat analysis. DISCUSSION: We expect that C1-INH administration will be safe and potentially effective to improve clinical outcomes by reducing neuroinflammation in TBI patients.

trial registrationClinicalTrials.gov NCT04489160. Registered on 27 July 2020. EudraCT 2020-000140-58.

Indexed as

Brain InjuriesBrain Injuries, TraumaticAdultHumansIntention to Treat AnalysisMulticenter Studies as TopicNeuroinflammatory DiseasesRandomized Controlled Trials as TopicC1-inhibitorNeuroinflammationRandomized controlled trialsTraumatic brain injury

Identifiers

PMID34863258
PMCPMC8642972
OpenAlexW4200050524

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.