Hemopatch Performance Evaluation: A Prospective Observational Registry

Air Leakage Clinical Trial

Official title:

Hemopatch Performance Evaluation: A Prospective Observational Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392662
• Other study ID #: BXU011443
• Status: Completed
• Start date: November 29, 2017
• Est. completion date: January 28, 2019

Study information

• Verified date: November 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Hemopatch
Patients received product at the discretion of their surgeon.

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Czechia	Fakultní nemocnice u sv. Anny v Brne	Brno
Czechia	Krajská Nemocnice Liberec	Liberec
Czechia	Fakultní Nemocnice Ostrava	Ostrava
Czechia	Thomayerova Nemocnice	Praha 4
Germany	Marien-Krankenhaus Bergisch Gladbach	Bergisch Gladbach
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	ASKLEPIOS Klinik St. Georg	Hamburg
Germany	Universitaetsklinikum Regensburg	Regensburg
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Spain	Hospital de Vall d'Hebrón	Barcelona
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  Czechia,  Germany,  Italy,  Spain, 

References & 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(®) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving hemostasis after 2 minutes of surgery		Day 1 (up to 2 minutes postoperative)
Primary	Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure		Day 1 (intraoperative)
Primary	Absence of air leak in lung at time of surgical closure		Day 1 (intraoperative)
Primary	Tight closure achieved in dura mater at time of surgical closure	No leak after inspection per local standard of care	Day 1 (intraoperative)
Primary	Number of patients with chest tube drainage >=5 days after thoracic/lung surgery		Day 5 up to 4 weeks (postoperative)
Primary	Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery		Up to 4 weeks (postoperative)
Primary	Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery		Up to 4 weeks (postoperative)
Primary	Duration of bile leakage after hepatobiliary surgery		Up to 4 weeks (postoperative)
Primary	Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery	External or internal accumulation including pseudomeningocele	Up to 4 weeks (postoperative)
Primary	Number of patients with postoperative urinary fistula formation after urological surgery		Up to 4 weeks (postoperative)
Primary	Gastrointestinal anastomosis leakage/fistula after general surgery		Up to 4 weeks (postoperative)
Primary	Number of patients with related Adverse Events		Up to 4 weeks (postoperative)
Secondary	Number of Hemopatch units applied		Up to 4 weeks (postoperative)
Secondary	Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage		Up to 4 weeks (postoperative)
Secondary	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)
Secondary	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)
Secondary	Surgery duration		Day 1 (intraoperative)
Secondary	Length of hospital stay	Intensive Care Unit (ICU) and hospital	Up to 4 weeks (postoperative)
Secondary	Ease of product preparation	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Secondary	Ease of product handling	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Secondary	Assessment of product tissue adherence	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Secondary	Surgeon's overall satisfaction of product	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Secondary	Product characteristics appreciated by Surgeon	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)
Secondary	Product characteristics liked least by Surgeon	Surgeon's overall product assessment and satisfaction recorded on questionnaire.	Day 1 (intraoperative)