Evidence map›Paper›PMID 30127466›Full record

Trial reportBone marrow transplantation2019

Clinical effects of recombinant thrombomodulin and defibrotide on sinusoidal obstruction syndrome after allogeneic hematopoietic stem cell transplantation.

Kimikazu Yakushijin, Takayuki Ikezoe, Chikako Ohwada, Kazuko Kudo, Hiroshi Okamura, Hiroaki Goto, Hiromasa Yabe, Atsushi Yasumoto, Hideyuki Kuwabara, Shiro Fujii and 19 more

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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.

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

11 citing papers in PubMed.

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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

29 authors.

Kimikazu YakushijinDepartment of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan. kyakushi@med.kobe-u.ac.jp.ORCID http://orcid.org/0000-0003-2511-7857
Takayuki IkezoeDepartment of Hematology, Fukushima Medical School, Fukushima, Japan.
Chikako OhwadaDepartment of Hematology, Chiba University Hospital, Chiba, Japan.
Kazuko KudoDepartment of Pediatrics, Fujita Health University School of Medicine, Aichi, Japan.
Hiroshi OkamuraHematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Hiroaki GotoDivision of Hemato-Oncology and Regenerative Medicine, Kanagawa Children's Medical Center, Yokohama, Japan.
Hiromasa YabeDepartment of Cell Transplantation and Regenerative Medicine, Tokai University School of Medicine, Isehara, Japan.ORCID http://orcid.org/0000-0001-6508-5496
Atsushi YasumotoDepartment of Hematology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Hideyuki KuwabaraDepartment of Hematology, Yokohama City University Medical Center, Yokohama, Japan.
Shiro FujiiDepartment of Hematology, Endocrinology and Metabolism, Tokushima University Graduate School, Tokushima, Japan.
Kumiko KagawaDepartment of Hematology, Endocrinology and Metabolism, Tokushima University Graduate School, Tokushima, Japan.
Masao OgataDepartment of Hematology, Oita University Hospital, Oita, Japan.ORCID http://orcid.org/0000-0002-4896-5878
Yasushi OnishiDepartment of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.
Akio KohnoDepartment of Hematology and Oncology, Konan Kosei Hospital, Aichi, Japan.
Koichi WatamotoDepartment of Hematology and Oncology, Konan Kosei Hospital, Aichi, Japan.
Nobuhiko UoshimaDepartment of Hematology, Matsushita Memorial Hospital, Osaka, Japan.
Daisuke NakamuraDepartment of Hematology and Immunology, Kagoshima University Hospital, Kagoshima, Japan.
Shuichi OtaDepartment of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Yasunori UedaDepartment of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan.
Tatsuo OyakeDepartment of Hematology and Oncology, Internal Medicine, Iwate Medical University School of Medicine, Morioka, Japan.
Kazutoshi KoikeDivision of Pediatric Hematology and Oncology, Ibaraki Children's Hospital, Mito, Japan.
Ishikazu MizunoDepartment of Hematology, Hyogo Cancer Center, Hyogo, Japan.
Hiroatsu IidaDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yoshio KatayamaDivision of Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Hiroatsu AgoDepartment of Hematology and Oncology, Shimane Prefectural Central Hospital, Izumo, Japan.
Koji KatoDepartment of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Atsuo OkamuraDepartment of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
Atsushi KikutaDepartment of Pediatric Oncology, Fukushima Medical University, Fukushima, Japan.
Takahiro FukudaDepartment of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sinusoidal obstruction syndrome (SOS) is a lethal complication after hematopoietic stem cell transplantation (HSCT). Defibrotide (DF) is the only drug internationally recommended for SOS treatment in Western countries. Recombinant human soluble thrombomodulin (rhTM), which is promising for the treatment of patients with disseminated intravascular coagulation, is also reported to be potentially effective for SOS. To clarify the safety and efficacy of DF and rhTM, we conducted a retrospective survey of these agents in Japan. Data from 65 patients who underwent allogeneic HSCT and received DF (n  =  24) or rhTM (n  =  41) for SOS treatment were collected. The complete response rates for SOS on day 100 were 50% and 54% in the DF and rhTM groups, respectively. The 100-day overall survival rates were 50% in the DF group, and 48% in the rhTM group. Several severe hemorrhagic adverse events were observed in one patient in the DF group and five patients in the rhTM group. The main causes of death were SOS-related death, and no patient died of direct adverse events of DF or rhTM. Our results suggest that rhTM, as well as DF, can be effective as a novel treatment option for SOS.

Indexed as

Hematopoietic Stem Cell TransplantationHepatic Veno-Occlusive DiseaseAdolescentAdultAgedAllograftsChildChild, PreschoolDisease-Free SurvivalFemaleHumansInfantInfant, NewbornJapanMaleMiddle AgeddefibrotidePolydeoxyribonucleotidesRecombinant ProteinsTHBD protein, humanThrombomodulin

Identifiers

What OpenQuestion holds

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Registered trials

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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.