Trial reportHPB : the official journal of the International Hepato Pancreato Biliary Association2016
A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.
Trial report in HPB : the official journal of the International Hepato Pancreato Biliary Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01993888 (A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled 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.
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.
A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Haemostatic Efficacy of Topical Agents During Liver Resection: A Network Meta-Analysis of Randomised Trials.World journal of surgery · 2020Pooled it
- A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2018Trial
- Safety and efficacy of HLBLS-200 (BleeFix) as a novel hemostatic agent in hepatic surgery: a multicenter, randomized, active-controlled clinical trial.Annals of surgical treatment and research · 2026Article
- Passive, Active, or Both-What Hemostats Do Surgeons Choose in the Real World, and Should We Rethink It?Medical devices (Auckland, N.Z.) · 2025Article
- TAVAC: comprehensive review of currently available hemostatic products as adjunct to surgical hemostasis.Surgical endoscopy · 2024Review
- NHS-POx-loaded patch versus fibrin sealant patch in a porcine robotic liver bleeding model.BMC surgery · 2023Article
- Fibrin-based haemostatic agents for reducing blood loss in adult liver resection.The Cochrane database of systematic reviews · 2023Review
- Minimizing blood loss and transfusion rate in laparoscopic liver surgery: a review.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2023Review
- Application and outlook of topical hemostatic materials: a narrative review.Annals of translational medicine · 2021Review
- Topical biomaterials to prevent post-tonsillectomy hemorrhage.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2019Review
- A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.ClinicoEconomics and outcomes research : CEOR · 2016Article
- Robot-Assisted Laparoscopic Application of Fibrin Sealant Patch for Repair of Inferior Vena Cava.CRSLS : MIS case reports from SLSArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis multicentre, randomized clinical trial assessed the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch (FP) in treating parenchymal bleeding following anatomic and non-anatomic liver resections.
methodsOne hundred and two patients were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized (1:1) after identification of an appropriate bleeding site, to FP vs Standard of Care (SoC, manual compression ± topical haemostat). The primary endpoint was haemostasis at 4 min from bleeding site identification with no re-bleeding requiring re-treatment.
resultsThe FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). Stratification for resection type showed treatment differences for primary endpoint for anatomic (24/25 FP vs 13/23 SoC; p = 0.001) and non-anatomic liver resections (24/25FP vs 11/29 SoC; p < 0.001). Adverse events related to the study procedure were reported in 40/50 patients (80%) in the FP group and 43/52 patients (83%) in the SoC group. One (2%) adverse event (infected intra-abdominal fluid collection) was possibly related to study treatment.
conclusionThis clinical trial confirms that the FP is safe and highly effective in controlling parenchymal bleeding following hepatectomy regardless of the type of resection. ClinicalTrials.gov NCT01993888.
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What OpenQuestion holds
Registered trials
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.