Evidence map›Paper›PMID 28365804›Full record

Trial reportLangenbeck's archives of surgery2017

Comparison of TachoSil and TachoComb in patients undergoing liver resection-a randomized, double-blind, non-inferiority trial.

S Kawasaki, H Origasa, V Tetens, M Kobayashi

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Langenbeck's archives of surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. A new hemostatic agent composed of ZnBioactive materials · 2022
    Article
  9. Article
  10. Article
  11. Review
  12. Topical biomaterials to prevent post-tonsillectomy hemorrhage.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2019
    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

4 authors at 4 institutions in 2 countries.

S KawasakiDepartment of Hepatobiliary Pancreatic Surgery, Juntendo University Graduate School of Medicine, Tokyo, Japan.
H OrigasaDivision of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama City, Japan.
V TetensClinical Science, Takeda Development Centre Europe Ltd, London, UK.
M KobayashiR&D Japan, CSL Behring K.K, 1-7-12 Shinonome, Koto-ku, Tokyo, 135-0062, Japan. Midori.Kobayashi@cslbehring.com.
CSL (Japan) · JPJuntendo University · JPTakeda (United Kingdom) · GBUniversity of Toyama · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aimed to demonstrate the noninferior efficacy of TachoSil vs. TachoComb in Japanese patients undergoing liver resection and to assess the safety of TachoSil vs. TachoComb in these patients.

methodsThis randomized, double-blind, noninferiority study (JapicCTI-090684) involved participants scheduled for liver resection/living donors (age ≥ 20 years). TachoSil or TachoComb (1:1 allocation ratio) was applied to control persistent exudative bleeding after primary hemostasis during liver resection/removal for donation. The primary outcome was hemostasis 5 min after study treatment application. The 95% confidence interval (CI) for the difference in the proportion of participants with hemostasis 5 min after application of TachoSil/TachoComb was determined; noninferiority of TachoSil was indicated if the lower limit of the CI was ≥-14%. Adverse events (AEs) were recorded.

resultsAll participants in the efficacy analysis (TachoSil: 54/54, 100%; TachoComb: 54/54, 100%) achieved hemostasis 5 min after study treatment application. Therefore, TachoSil was noninferior to TachoComb. All participants experienced ≥1 AE; however, none discontinued because of an AE. Most (≥97.8%) AEs were mild or moderate in severity.

conclusionsThese findings confirm the safety profile and noninferior hemostatic efficacy of TachoSil compared with TachoComb.

Indexed as

Hemostasis, SurgicalAgedAprotininBlood Loss, SurgicalDouble-Blind MethodDrug CombinationsFemaleFibrinogenHemostaticsHepatectomyHumansMaleMiddle AgedThrombinTreatment OutcomeAprotininDrug CombinationsFibrinogenHemostaticstachocombTachoSilThrombinHemostasisJapanLiverSafetyTachoCombTachoSil

Identifiers

PMID28365804
PMCPMC5437221
OpenAlexW2602672937

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.