Evidence map›Paper›PMID 25520842›Full record

ArticleJournal of intensive care2014

Post-marketing surveillance data of thrombomodulin alfa: sub-analysis in patients with sepsis-induced disseminated intravascular coagulation.

Yutaka Eguchi, Satoshi Gando, Hiroyasu Ishikura, Daizoh Saitoh, Jun Mimuro, Hoyu Takahashi, Isao Kitajima, Hajime Tsuji, Tadashi Matsushita, Ryuichi Tsujita and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of intensive care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.4field-weighted citation impact, top 12% 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

18 citing papers in PubMed, 36 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Benefit Profile of Thrombomodulin Alfa Combined with Antithrombin Concentrate in Patients with Sepsis-Induced Disseminated Intravascular Coagulation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
  17. Effect of Recombinant Human Soluble Thrombomodulin on Coagulation-Related Variables in Patients With Sepsis-Induced Disseminated Intravascular Coagulation: A Retrospective Observational Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
  18. Severe Antithrombin Deficiency May be Associated With a High Risk of Pathological Progression of DIC With Suppressed Fibrinolysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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 10 institutions in 1 country.

Yutaka EguchiDepartment of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Satoshi GandoDivision of Acute and Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.
Hiroyasu IshikuraDepartment of Emergency and Critical Care Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Daizoh SaitohDivision of Traumatology, National Defense Medical College Research Institute, National Defense Medical College, Saitama, Japan.
Jun MimuroDivision of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Hoyu TakahashiDepartment of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Isao KitajimaDepartment of Clinical Laboratory and Molecular Pathology, Graduate School of Medical and Pharmaceutical Science, University of Toyama, Toyama, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Hajime TsujiDepartment of Blood Transfusion, Kyoto Prefectural University of Medicine, Kyoto, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Tadashi MatsushitaDepartment of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Ryuichi TsujitaART Project, Pharmaceuticals Sales Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Osamu NagaoPost-Marketing Surveillance Dept. Reliability Assurance Center, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Yoichi SakataDivision of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan ; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin® Injection, Tokyo, Japan.
Asahi Kasei (Japan) · JPJichi Medical University · JPFukuoka University · JPHanazono Hospital · JPHokkaido University · JPKyoto Prefectural University of Medicine · JPNagoya University Hospital · JPNational Defense Medical College · JPShiga University of Medical Science · JPUniversity of Toyama · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThrombomodulin alfa (TM-α, recombinant thrombomodulin) significantly improved disseminated intravascular coagulation (DIC) when compared with heparin therapy in a phase III study. Post-marketing surveillance of TM-α was performed to evaluate the effects and safety in patients with sepsis-induced DIC.

methodsFrom May 2008 to April 2010, a total of 1,787 patients with sepsis-induced DIC treated with TM-α were registered. DIC was diagnosed based on the Japanese Association for Acute Medicine (JAAM) criteria. The DIC resolution and survival rates on day 28 after the last TM-α administration, and changes in DIC, systemic inflammatory response syndrome (SIRS), and sequential organ failure assessment (SOFA) scores and coagulation and inflammation markers were evaluated.

resultsThe most frequent underlying disease was infectious focus-unknown sepsis (29.8%). The mean ± SD values of age, dose, and the duration of TM-α administration were 64.7 ± 20.3 years, 297.3 ± 111.4 U/kg/day, and 5.6 ± 3.4 days, respectively. A total of 1,320 subjects (73.9%) received combined administration with other anticoagulants. Both coagulation and inflammation markers, such as fibrin/fibrinogen degradation products, prothrombin time ratio, thrombin-antithrombin complex, and C-reactive protein, as well as JAAM DIC, SIRS, and SOFA scores, significantly and simultaneously decreased after TM-α administration (p < 0.001). DIC resolution and 28-day survival rates were 44.4% and 66.0%, respectively. The 28-day survival rate decreased significantly according to the duration of DIC before TM-α administration (p < 0.001). Total adverse drug reactions (ADRs), bleeding ADRs, and serious bleeding adverse events occurred in 126 (7.1%), 98 (5.5%), and 121 (6.8%) subjects, respectively. On day 28, after the last TM-α administration available for an antibody test, only one patient was positive for anti-TM-α antibodies (0.11%).

conclusionOur results suggest that TM-α is most effective for treating patients with sepsis-induced DIC when administered within the first 3 days after diagnosis.

Indexed as

AnticoagulantJAAM criteriaSepsisSIRSSOFA score

Identifiers

PMID25520842
PMCPMC4267702
OpenAlexW2118999793

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.