Evidence map›Paper›PMID 37427979›Full record

Trial reportScience progress

Fibrin Sealant TISSEEL Lyo as a haemostatic agent in vascular surgery: Results of randomized, controlled, patient-blinded, multicentre clinical study in the Russian population.

Andrey A Karpenko, Alexey V Cheban, Artem A Rabtsun, German Y Sokurenko, Konstantin A Andreychuk, Igor N Kim, Valentin A Volf, Maksim R Kuznetsov, Igor I Prostov, Natalia G Sapronova and 3 more

Open access · diamondAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Science progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 28% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

13 authors at 5 institutions in 1 country.

Andrey A KarpenkoNational Research Center Named after Academician E.N. Meshalkin, Novosibirsk, Russia.
Alexey V ChebanNational Research Center Named after Academician E.N. Meshalkin, Novosibirsk, Russia.ORCID 0000-0002-6094-4607
Artem A RabtsunNational Research Center Named after Academician E.N. Meshalkin, Novosibirsk, Russia.
German Y SokurenkoA.M. Nikiforov All-Russian Center of Emergency and Radiation Medicine, St-Petersburg, Russia.
Konstantin A AndreychukA.M. Nikiforov All-Russian Center of Emergency and Radiation Medicine, St-Petersburg, Russia.
Igor N KimState Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia.
Valentin A VolfState Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia.
Maksim R KuznetsovInstitute of Cluster Oncology Named after L. L. Levshin of the Sechenov University, Moscow, Russia.
Igor I ProstovRostov State Medical University, Rostov-on-Don, Russia.
Natalia G SapronovaRostov State Medical University, Rostov-on-Don, Russia.
Nina D MzhavanadzeRyazan State Medical University Named after Academician I.P. Pavlov, Ryazan, Russia.ORCID 0000-0001-5437-1112
Alexey A KamaevRyazan State Medical University Named after Academician I.P. Pavlov, Ryazan, Russia.
Igor A SuchkovRyazan State Medical University Named after Academician I.P. Pavlov, Ryazan, Russia.ORCID 0000-0002-1292-5452
Meshalkin National Medical Research Center · RURyazan State Medical University named after Academician I.P. Pavlov · RUNikiforov Russian Center of Emergency and Radiation Medicine · RURostov State Medical University · RUSechenov University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia.

methodsAdult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T

resultsA total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T

conclusionsData demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.

Indexed as

HemostaticsSurgical WoundAdultBlood Loss, SurgicalFemaleFibrin Tissue AdhesiveHumansMaleVascular Surgical ProceduresFibrin Tissue AdhesiveHemostaticsFibrin sealantsurgerythrombinTISSEEL Lyo

Identifiers

PMID37427979
PMCPMC10358634
OpenAlexW4383710074

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.