Hemopatch Performance Evaluation: A Prospective Observational Registry

To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.

Study Overview

• Status: Completed
• Conditions: Air Leakage; Dura Mater Nick Cut or Tear; Hemostatis; Body Fluid Leakage
• Intervention / Treatment: Device: Hemopatch

• Study Type: Observational
• Enrollment (Actual): 621

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Innsbruck Universitaetsklinik
• Czechia
  • Brno, Czechia, 65691
    • Fakultni nemocnice u sv. Anny v Brne
  • Liberec, Czechia, 46063
    • Krajská nemocnice Liberec
  • Ostrava, Czechia, 70852
    • Fakultni nemocnice Ostrava
  • Praha 4, Czechia, 14059
    • Thomayerova nemocnice
• Germany
  • Bergisch Gladbach, Germany
    • Marien-Krankenhaus Bergisch Gladbach
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Regensburg, Germany, 93042
    • Universitaetsklinikum Regensburg
• Italy
  • Firenze, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi
• Spain
  • Barcelona, Spain, 8035
    • Hospital de Vall D'Hebron
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Doctor Josep Trueta
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient who had undergone a general, cardiovascular, thoracic, urological, or neurological surgery during which the use of a patch was required to repair the dura or to achieve hemostasis, control leakage of air or other body fluid because pressure, ligature or conventional procedures were ineffective or impractical and during which Hemopatch was used according to Instructions for use.

Description

Inclusion Criteria:

• Male or female patients of any age

• Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:

  1. Hepato-biliary (liver, pancreas, gallbladder)
  2. General surgery (in thyroid and other regions)
  3. Cardiovascular (heart and vessels)
  4. thoracic (lung and mediastinum)
  5. Urological (kidney, prostate, and bladder
  6. Neurological (dura mater, brain and spinal cord)
• Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery

Exclusion Criteria:

• Patients with known hypersensitivity to bovine proteins or brilliant blue
• Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
• Patients who had an active infection at the TAS

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemopatch Sealant Use with Hepatobiliary Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with General Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Lung Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Cardiovascular Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Neurological/Spinal Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Urologic Surgery	Device: Hemopatch; Patients received product at the discretion of their surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving hemostasis after 2 minutes of surgery		Day 1 (up to 2 minutes postoperative)
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure		Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure		Day 1 (intraoperative)
Tight closure achieved in dura mater at time of surgical closure	No leak after inspection per local standard of care	Day 1 (intraoperative)
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery		Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery		Up to 4 weeks (postoperative)
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery		Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery		Up to 4 weeks (postoperative)
Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery	External or internal accumulation including pseudomeningocele	Up to 4 weeks (postoperative)
Number of patients with postoperative urinary fistula formation after urological surgery		Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery		Up to 4 weeks (postoperative)
Number of patients with related Adverse Events		Up to 4 weeks (postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hemopatch units applied		Up to 4 weeks (postoperative)
Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage		Up to 4 weeks (postoperative)
Number of intraoperative transfusions by type and amount of blood product transfused	Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.	Day 1 (intraoperative)
Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery	Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.	Up to 72 hours (postoperative)
Surgery duration		Day 1 (intraoperative)
Length of hospital stay	Intensive Care Unit (ICU) and hospital	Up to 4 weeks (postoperative)
Ease of product preparation	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Ease of product handling	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Assessment of product tissue adherence	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Surgeon's overall satisfaction of product	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Product characteristics appreciated by Surgeon	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Product characteristics liked least by Surgeon	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Lombardo C, Lopez-Ben S, Boggi U, Gutowski P, Hrbac T, Krska L, Marquez-Rivas J, Russello D, York E, Zacharias M. Hemopatch(R) is effective and safe to use: real-world data from a prospective European registry study. Updates Surg. 2022 Oct;74(5):1521-1531. doi: 10.1007/s13304-022-01353-y. Epub 2022 Aug 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2017
• Primary Completion (ACTUAL): January 28, 2019
• Study Completion (ACTUAL): January 28, 2019

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (ACTUAL): January 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BXU011443

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No