NCT03166683

Brief Summary

This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

April 4, 2017

Last Update Submit

November 8, 2017

Conditions

Liver CancerHemorrhage LiverBile LeakSurgeryTumor Liver

Outcome Measures

Primary Outcomes (1)

  • Control of bile leakage

    analysis of bilirubin (mg/dL),in the drain fluid

    From day 1 to day 4

Secondary Outcomes (4)

  • Bleeding

    From the surgery day until day 30

  • Analysis of hemoglobin

    From the surgery day until day 30

  • Bleeding complications

    From the surgery day until day 30

  • Transfusion requirements

    From the surgery day until day 30

Other Outcomes (3)

  • Bile leakage severity

    From the surgery day until day 30

  • Morbidity

    From the surgery day until day 30

  • Mortality

    From the surgery day until day 30

Study Arms (2)

Hemopatch

EXPERIMENTAL

Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.

Other: Hemopatch

Standard of care

ACTIVE COMPARATOR

Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.

Other: Standard of care

Interventions

HemopatchOTHER

Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement

Hemopatch
Standard of careOTHER

Standard of care include other sealant / hemostatic devices as patches or liquid/gels

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥18 years.
  • Patients with an indication for open liver resection (segmental or non-segmental).
  • Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
  • Willing and able to complete the clinical trial procedures, as described in the protocol.
  • Signed written informed consent to participate in this clinical trial.

You may not qualify if:

  • Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
  • Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
  • Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
  • Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
  • Pregnancy or breast-feeding.
  • Inability to understand the nature and the extent of the trial and the procedures required.
  • Infected wound area.
  • Persistent major bleeding after primary hemostasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Baumgartner B, Draxler W, Lewis KM. Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy. J Invest Surg. 2016 Dec;29(6):343-351. doi: 10.3109/08941939.2016.1154627. Epub 2016 Mar 22.

    PMID: 27002742BACKGROUND

  • Erdogan D, Busch OR, van Delden OM, Rauws EA, Gouma DJ, van Gulik TM. Incidence and management of bile leakage after partial liver resection. Dig Surg. 2008;25(1):60-6. doi: 10.1159/000118024. Epub 2008 Feb 22.

    PMID: 18292662BACKGROUND

  • Figueras J, Llado L, Miro M, Ramos E, Torras J, Fabregat J, Serrano T. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Ann Surg. 2007 Apr;245(4):536-42. doi: 10.1097/01.sla.0000245846.37046.57.

    PMID: 17414601BACKGROUND

  • Guillaud A, Pery C, Campillo B, Lourdais A, Sulpice L, Boudjema K. Incidence and predictive factors of clinically relevant bile leakage in the modern era of liver resections. HPB (Oxford). 2013 Mar;15(3):224-9. doi: 10.1111/j.1477-2574.2012.00580.x. Epub 2012 Oct 4.

    PMID: 23374363BACKGROUND

  • Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014.

    PMID: 24729905BACKGROUND

  • Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6.

    PMID: 25106082BACKGROUND

  • Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.

    PMID: 25085811BACKGROUND

  • Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, Buchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7.

    PMID: 21762295BACKGROUND

  • Nagano Y, Togo S, Tanaka K, Masui H, Endo I, Sekido H, Nagahori K, Shimada H. Risk factors and management of bile leakage after hepatic resection. World J Surg. 2003 Jun;27(6):695-8. doi: 10.1007/s00268-003-6907-x. Epub 2003 May 13.

    PMID: 12732991BACKGROUND

  • Ruggiero R, Docimo L, Tolone S, De Palma M, Musella M, Pezzolla A, Gubitosi A, Parmeggiani D, Pirozzi R, Gili S, Parisi S, D'Alessandro A, Docimo G. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery. A prospective study. Int J Surg. 2016 Apr;28 Suppl 1:S17-21. doi: 10.1016/j.ijsu.2015.12.044. Epub 2015 Dec 17.

    PMID: 26708861BACKGROUND

  • Sadamori H, Yagi T, Matsuda H, Shinoura S, Umeda Y, Fujiwara T. Intractable bile leakage after hepatectomy for hepatocellular carcinoma in 359 recent cases. Dig Surg. 2012;29(2):149-56. doi: 10.1159/000337313. Epub 2012 May 3.

    PMID: 22555445BACKGROUND

  • Sakamoto K, Tamesa T, Yukio T, Tokuhisa Y, Maeda Y, Oka M. Risk Factors and Managements of Bile Leakage After Hepatectomy. World J Surg. 2016 Jan;40(1):182-9. doi: 10.1007/s00268-015-3156-8.

    PMID: 26159119BACKGROUND

  • Tanaka S, Hirohashi K, Tanaka H, Shuto T, Lee SH, Kubo S, Takemura S, Yamamoto T, Uenishi T, Kinoshita H. Incidence and management of bile leakage after hepatic resection for malignant hepatic tumors. J Am Coll Surg. 2002 Oct;195(4):484-9. doi: 10.1016/s1072-7515(02)01288-7.

    PMID: 12375753BACKGROUND

  • Weltert L, D'Aleo S, Chirichilli I, Falco M, Turani F, Bellisario A, De Paulis R. Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery. Surg Technol Int. 2016 Oct;XXIX:sti29/756. Epub 2016 Jul 29.

    PMID: 27466878BACKGROUND

  • Yamashita Y, Hamatsu T, Rikimaru T, Tanaka S, Shirabe K, Shimada M, Sugimachi K. Bile leakage after hepatic resection. Ann Surg. 2001 Jan;233(1):45-50. doi: 10.1097/00000658-200101000-00008.

    PMID: 11141224BACKGROUND

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Miguel Angel Gómez Bravo, PhD

    Hospitales Universitarios Virgen del Rocío

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Rosso Fernández, PhD

CONTACT

0034955013414claram.rosso.sspa@juntadeandalucia.es

Lydia Barrera, PhD

CONTACT

0034955014236lydia.barrera.exts@juntadeandalucia.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

May 25, 2017

Study Start

December 1, 2017

Primary Completion

April 1, 2020

Study Completion

September 1, 2020

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Anonymized data for IPD is planned to be shared with all participants within 6 months of data completion

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 MONTHS