Standard of Care Versus Hemopatch® During Liver Resection
NCT ID: NCT03166683
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
284 participants
INTERVENTIONAL
2017-12-31
2020-09-30
Brief Summary
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Detailed Description
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A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) \[Baxter, Vienna, Austria\] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.
The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Hemopatch
Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.
Hemopatch
Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement
Standard of care
Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.
Standard of care
Standard of care include other sealant / hemostatic devices as patches or liquid/gels
Interventions
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Hemopatch
Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement
Standard of care
Standard of care include other sealant / hemostatic devices as patches or liquid/gels
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Miguel Angel Gómez Bravo, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IBERLIVER
Identifier Type: -
Identifier Source: org_study_id