Evidence map›Paper›PMID 32423894›Full record

Trial reportBMJ open respiratory research2020

Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial.

Toru Arai, Hiroshi Kida, Yoshitaka Ogata, Satoshi Marumo, Hiroto Matsuoka, Iwao Gohma, Suguru Yamamoto, Masahide Mori, Chikatoshi Sugimoto, Kazunobu Tachibana and 2 more

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMJ open respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 pooled it
0.1field-weighted citation impact, top 50% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. 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

12 authors at 7 institutions in 1 country.

Toru AraiClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.ORCID http://orcid.org/0000-0002-2222-0683
Hiroshi KidaDepartment of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
Yoshitaka OgataDepartment of Emergency and Critical Care Medicine, Hiroshima University, Hiroshima City, Hiroshima, Japan.
Satoshi MarumoRespiratory Disease Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka City, Osaka, Japan.
Hiroto MatsuokaDepartment of Respiratory Medicine, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, Osaka, Japan.
Iwao GohmaDepartment of Respiratory Medicine, Sakai City Medical Center, Sakai City, Osaka, Japan.
Suguru YamamotoDepartment of Respiratory Medicine, National Hospital Organization Osaka Minami Medical Center, Kawachinagano City, Osaka, Japan.
Masahide MoriDepartment of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka City, Osaka, Japan.
Chikatoshi SugimotoClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.
Kazunobu TachibanaClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.
Masanori AkiraDepartment of Radiology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.
Yoshikazu InoueClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan giichiyi@me.com.ORCID http://orcid.org/0000-0003-3994-874X
NHO Kinki Chuo Chest Medical Center · JPToneyama National Hospital · JPHiroshima University · JPKitano Hospital · JPOsaka Minami Medical Center · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.

methodsIn this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.

resultsWe developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).

conclusionsTreatment with rhTM might improve survival in AE-IIP cases with poor prognoses.

Indexed as

AdultAgedAged, 80 and overDisease ProgressionFemaleHumansIdiopathic Interstitial PneumoniasMaleMiddle AgedMultivariate AnalysisPrognosisProportional Hazards ModelsRecombinant ProteinsRespiratory System AgentsRetrospective StudiesSeverity of Illness IndexRecombinant ProteinsRespiratory System AgentsThrombomodulininterstitial fibrosis

Identifiers

PMID32423894
PMCPMC7239513
OpenAlexW3024411547

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.