Efficacy and Tolerability of Hemopatch After Hepatic Resection

NCT03323359 | Unknown DMC

• 1 other identifier: PAC-HEM-16-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

• Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen.
• Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries.
• In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture. These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.

Conditions

Hepatectomy; Cancer, Metastatic; Hemostasis

Keywords

Hemopatch; Hepatic resection; Hemostasis; Surgery

Outcome Measures

Primary Outcomes (1)

• Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch

  Evaluation of the improvement of the time of hemostasis

  Day 0 - T3 (Surgery)

Secondary Outcomes (5)

• reduction of the post-operative complications

  T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study)

• shorten the use of drainage tube after hepatic resection and the volume of the drainage

  T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study)

• the bile leaks

  T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study)

• any adverse event including, but not limited to, the length of hospital stay, rate of post-operative mortality

  T4 (+1d after Surgery) - Day 2; T5 (+2ds after Surgery) - Day 3; T6 (+3 to 6ds after Surgery) - Day 4 to 6; T7 (Follow-up 30±2ds) - Day 30; T8 (6-8ws after Surgery) end of the study)

• Intraoperative details

  Day 0 - T3 (Surgery)

Study Arms (2)

Hemopatch 45x90 mm - CE 0297 Class III

EXPERIMENTAL

Hemopatch + Common surgical techniques

Device: Hemopatch

Standard Surgery Technique

OTHER

Common surgical techniques

Procedure: Common Surgical Techniques

Interventions

Hemopatch DEVICE

Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.

Also known as: Hemopatch Sealing Hemostat, BAXTER

Hemopatch 45x90 mm - CE 0297 Class III

Common Surgical Techniques PROCEDURE

Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): Hepatocellular carcinoma, Hilar cholangiocarcinoma, Adrenal cancer metastasis, Breast cancer metastasis, Colorectal cancer metastasis, Ovarian cancer metastasis, Biliary carcinoma, Hemangioma, Hepatic adenoma, Focal nodular hyperplasia, Unilocular hydatid cyst, Multilocular, hydatid cyst.

Standard Surgery Technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatocellular carcinoma
• Hilar cholangiocarcinoma
• Adrenal cancer metastasis
• Breast cancer metastasis
• Colorectal cancer metastasis
• Ovarian cancer metastasis
• Biliary carcinoma
• Hemangioma
• Hepatic adenoma
• Focal nodular hyperplasia
• Unilocular hydatid cyst
• Multilocular hydatid cyst

You may not qualify if:

• Trauma surgery
• Active sepsis around the liver
• Documented history of cirrhosis
• Pregnant or nursing women
• Severe coagulopathy (defined as an International normalized ratio \>2.0)
• Severe Liver disfunction, as per clinical assessment
• Previous liver transplantation
• Laparoscopic procedure
• Any other intraoperative finding, which defines the no eligibility of the patient for liver resection
• Known hypersensitivity to bovine proteins or brilliant blue
• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

RECRUITING

Related Publications (16)

• Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.

  PMID: 12368667 RESULT

• Imamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. doi: 10.1001/archsurg.138.11.1198.

  PMID: 14609867 RESULT

• Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.

  PMID: 15383797 RESULT

• Jones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60. doi: 10.1046/j.1365-2168.1998.00795.x.

  PMID: 9717995 RESULT

• Smyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. doi: 10.1007/s00268-005-0025-x.

  PMID: 16222453 RESULT

• Ishizaki Y, Yoshimoto J, Miwa K, Sugo H, Kawasaki S. Safety of prolonged intermittent pringle maneuver during hepatic resection. Arch Surg. 2006 Jul;141(7):649-53; discussion 654. doi: 10.1001/archsurg.141.7.649.

  PMID: 16847234 RESULT

• Alkozai EM, Lisman T, Porte RJ. Bleeding in liver surgery: prevention and treatment. Clin Liver Dis. 2009 Feb;13(1):145-154. doi: 10.1016/j.cld.2008.09.012.

  PMID: 19150318 RESULT

• Poon RT. Current techniques of liver transection. HPB (Oxford). 2007;9(3):166-73. doi: 10.1080/13651820701216182.

  PMID: 18333217 RESULT

• Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.

  PMID: 19160307 RESULT

• 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: 25085811 RESULT

• 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: 25106082 RESULT

• Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch(R) as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015 Oct;33(10):1527-34. doi: 10.1007/s00345-014-1404-4. Epub 2014 Sep 20.

  PMID: 25239500 RESULT

• Fingerhut A, Uranues S, Ettorre GM, Felli E, Colasanti M, Scerrino G, Melfa GI, Raspanti C, Gulotta G, Meyer A, Oberhoffer M, Schmoeckel M, Weltert LP, Vignolini G, Salvi M, Masieri L, Vittori G, Siena G, Minervini A, Serni S, Carini M. European Initial Hands-On Experience with HEMOPATCH, a Novel Sealing Hemostatic Patch: Application in General, Gastrointestinal, Biliopancreatic, Cardiac, and Urologic Surgery. Surg Technol Int. 2014 Nov;25:29-35.

  PMID: 25433173 RESULT

• Jainandunsing JS, Al-Ansari S, Woltersom BD, Scheeren TW, Natour E. Novel hemostatic patch achieves sutureless epicardial wound closure during complex cardiac surgery, a case report. J Cardiothorac Surg. 2015 Jan 27;10:12. doi: 10.1186/s13019-015-0215-z.

  PMID: 25622592 RESULT

• Ollinger R, Mihaljevic AL, Schuhmacher C, Bektas H, Vondran F, Kleine M, Sainz-Barriga M, Weiss S, Knebel P, Pratschke J, Troisi RI. A multicentre, randomized clinical trial comparing the Veriset haemostatic patch with fibrin sealant for the management of bleeding during hepatic surgery. HPB (Oxford). 2013 Jul;15(7):548-58. doi: 10.1111/hpb.12009. Epub 2012 Dec 27.

  PMID: 23458162 RESULT

• Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.

  PMID: 23216780 RESULT

Related Links

• Hemopatch sealing
• Hemopatch Instructions for Use

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio FP Pacelli, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pacelli

CONTACT

00390630155133; fabio.pacelli@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 27, 2017
• Study Start: March 17, 2017
• Primary Completion: November 17, 2018
• Study Completion: March 17, 2019
• Last Updated: November 8, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)