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Efficacy and Tolerability of Hemopatch After Hepatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03323359
Recruitment Status : Unknown
Verified October 2017 by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Recruitment status was:  Recruiting
First Posted : October 27, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.


Condition or disease Intervention/treatment Phase
Hepatectomy Cancer, Metastatic Hemostasis Device: Hemopatch Procedure: Common Surgical Techniques Not Applicable

Detailed Description:

Advances in surgical techniques have reduced the occurrence of postoperative complications following liver resection and resulted in low surgical mortality and morbidity rates in high-volume centers.

Although partial liver resections for primary or secondary hepatic malignancies are considered standard interventions, intraoperative blood loss remains a risk factor associated with major complications in liver surgery [1-3]. There are several methods for reduction of blood loss, including meticulous resection technique along anatomical planes, reduction of central venous pressure during transection of the liver parenchyma [4], and vascular occlusion techniques (i.e., inflow occlusion and total vascular occlusion) [5-7]. In addition, specific instruments were devised for liver transection, such as the ultrasonic dissector, water jet, and other, more recent developments (e.g., focal radiofrequency ablation) that allow sealing of small vessels during transection [8, 9].

In order to control diffuse bleeding and to prevent intraperitoneal complications attributed to bleeding, various topical products are used when the conventional methods, such as suture, ligation, or argon beam coagulation, fail. Currently, there are numerous products on the market which are promising a successful outcome for hemostasis. These products include gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : November 17, 2018
Estimated Study Completion Date : March 17, 2019

Arm Intervention/treatment
Experimental: Hemopatch 45x90 mm - CE 0297 Class III
Hemopatch + Common surgical techniques
Device: Hemopatch
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.
Other Names:
  • Hemopatch Sealing Hemostat
  • BAXTER

Standard Surgery Technique
Common surgical techniques
Procedure: Common Surgical Techniques
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.




Primary Outcome Measures :
  1. Evaluated comparing the achievement of hemostasis within 3 minutes from the application of the patch [ Time Frame: Day 0 - T3 (Surgery) ]
    Evaluation of the improvement of the time of hemostasis


Secondary Outcome Measures :
  1. reduction of the post-operative complications [ Time Frame: 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) ]
    measurement of glucose, urea nitrogen, creatinine, sodium, potassium, calcium, total cholesterol, High Density Lipid and Low Density Lipid, triglyceride, alkaline phosphatase, Lactate Dehydrogenase, complete blood cell counts with differential and platelet counts, activated partial thromboplastin time, Prothrombin, international normalized ratio, fibrinogen, erythrocyte sedimentation rate, C-reactive Protein and Liver function tests, such as Alanine Transferase, Aspartate Transferase, Alkaline Phosphatase, bilirubin and total protein, gamma-glutamyl transferase

  2. shorten the use of drainage tube after hepatic resection and the volume of the drainage [ Time Frame: 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) ]
    measurement of drain pigmentation, i.e.biliary bloody clear

  3. the bile leaks [ Time Frame: 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) ]
    Abdominal ultrasound

  4. any adverse event including, but not limited to, the length of hospital stay, rate of post-operative mortality [ Time Frame: 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) ]
    Incidence of Adverse Events

  5. Intraoperative details [ Time Frame: Day 0 - T3 (Surgery) ]
    Evaluation of the hepatic parenchyma characteristics, intraoperative measurement of total volume of transfused blood products, type of the hepatic resection, the estimated intraoperative blood loss, the use of Pringle's maneuver



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323359


Contacts
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Contact: Pacelli 00390630155133 ext 4477 fabio.pacelli@policlinicogemelli.it

Locations
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Italy
Policlinico Universitario Agostino Gemelli Recruiting
Rome, Italy, 00168
Contact: Pacelli    00390630155133 ext 4477    fabio.pacelli@policlinicogemelli.it   
Principal Investigator: Fabio FP Pacelli, MD         
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Fabio FP Pacelli, MD Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Study Documents (Full-Text)

Documents provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Study Protocol  [PDF] April 1, 2017

Additional Information:
Publications of Results:

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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03323359    
Other Study ID Numbers: PAC-HEM-16-001
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Hemopatch
Hepatic resection
Hemostasis
Surgery