Evidence map›Paper›PMID 33134780›Full record

ArticleResearch and practice in thrombosis and haemostasis2020

Effects of thrombomodulin alfa on hemostatic parameters in disseminated intravascular coagulation: Post hoc analysis of a phase 3 randomized controlled trial.

Takashi Ito, Ikuro Maruyama, Shuji Shimazaki, Yasuhiro Yamamoto, Naoki Aikawa, Akio Hirayama, Goichi Honda, Hidehiko Saito

Open access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 21% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

8 authors at 6 institutions in 1 country.

Takashi ItoDepartment of Systems Biology in Thromboregulation Kagoshima University Graduates School of Medical and Dental Sciences Kagoshima Japan.ORCID https://orcid.org/0000-0002-6204-8400
Ikuro MaruyamaDepartment of Systems Biology in Thromboregulation Kagoshima University Graduates School of Medical and Dental Sciences Kagoshima Japan.
Shuji ShimazakiDepartment of Emergency Medical System Disaster and EMS Rescue Institute Kokushikan University Tokyo Japan.
Yasuhiro YamamotoTokyo Hikifune Hospital Tokyo Japan.
Naoki AikawaKeio University Tokyo Japan.
Akio HirayamaOgino Hospital Hokkaido Japan.
Goichi HondaAsahi Kasei Pharma Corporation Tokyo Japan.ORCID https://orcid.org/0000-0002-4916-7640
Hidehiko SaitoNational Hospital Organization Nagoya Medical Center Aichi Japan.
Kagoshima University · JPAsahi Kasei (Japan) · JPKeio University · JPKokushikan University · JPNational Hospital Organization · JPNew Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of thrombomodulin alfa (TM-α), a cofactor protein promoting thrombin-mediated protein C activation, have been examined in a phase 3 randomized, double-blinded, parallel-group trial in Japan. We have previously reported that TM-α is noninferior to heparin for the resolution of disseminated intravascular coagulation (DIC).

objectiveTo investigate the basis for the efficacy of TM-α in the phase 3 clinical trial in Japan through post hoc analysis of coagulation and fibrinolysis parameters. PATIENTS/

methodsThe 227 patients of the full analysis set population described in the original phase 3 trial in Japan were included in this analysis. Changes in parameters between before and after TM-α or heparin administration in each of the two patient groups, with underlying diseases of either hematologic malignancy or infection, were studied separately and results were compared between TM-α and heparin treatment groups in a post hoc manner.

resultsTM-α administration did not prolong activated partial thromboplastin time but significantly decreased thrombin-antithrombin complex levels compared with heparin treatment. TM-α administration reduced consumption of endogenous anticoagulants such as antithrombin and protein C by DIC, compared with the heparin group. DIC scores were decreased in both TM-α and heparin groups during the 6-day treatment.

conclusionTM-α can alleviate intravascular coagulation and consumption of anticoagulants without extending coagulation times. This may be associated with the relatively low risk of bleeding during TM-α treatment.

Indexed as

disseminated intravascular coagulationheparinprotein Cthrombinthrombomodulin

Identifiers

PMID33134780
PMCPMC7590306
OpenAlexW3048930724

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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.