Hemopatch Performance Evaluation: A Prospective Observational Registry

NCT03392662 | Completed FDA Device

• 1 other identifier: BXU011443
• Study Type: observational
• Target: 621
• Locations: 5 countries
• Sites: 15

Brief Summary

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.

Conditions

Dura Mater Nick Cut or Tear; Hemostatis; Air Leakage; Body Fluid Leakage

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• 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

  Day 1 (intraoperative)

• Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery

  Up to 72 hours (postoperative)

• Surgery duration

  Day 1 (intraoperative)

Study Arms (6)

Hemopatch Sealant Use with Hepatobiliary Surgery

Device: Hemopatch

Hemopatch Sealant Use with General Surgery

Device: Hemopatch

Hemopatch Sealant Use with Lung Surgery

Device: Hemopatch

Hemopatch Sealant Use with Cardiovascular Surgery

Device: Hemopatch

Hemopatch Sealant Use with Neurological/Spinal Surgery

Device: Hemopatch

Hemopatch Sealant Use with Urologic Surgery

Device: Hemopatch

Interventions

Hemopatch DEVICE

Patients received product at the discretion of their surgeon.

Hemopatch Sealant Use with Cardiovascular Surgery; Hemopatch Sealant Use with General Surgery; Hemopatch Sealant Use with Hepatobiliary Surgery; Hemopatch Sealant Use with Lung Surgery; Hemopatch Sealant Use with Neurological/Spinal Surgery; Hemopatch Sealant Use with Urologic Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (15)

Innsbruck Universitaetsklinik

Innsbruck, 6020, Austria

Location

Fakultní nemocnice u sv. Anny v Brně

Brno, 65691, Czechia

Location

Krajská Nemocnice Liberec

Liberec, 46063, Czechia

Location

Fakultní Nemocnice Ostrava

Ostrava, 70852, Czechia

Location

Thomayerova Nemocnice

Prague, 14059, Czechia

Location

Marien-Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

ASKLEPIOS Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitaetsklinikum Regensburg

Regensburg, 93042, Germany

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Hospital de Vall d'Hebrón

Barcelona, 8035, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Related Publications (1)

• 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.

  PMID: 35986865 BACKGROUND

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 8, 2018
• Study Start: November 29, 2017
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

AU (1); IT (1); CZ (4); DE (4); ES (5)