Clinical trial NCT03392662: Hemopatch Performance Evaluation: A Prospective Observational Registry
Official title: Hemopatch Performance Evaluation: A Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dura Mater Nick Cut or Tear
Hemostatis
Air Leakage
Body Fluid Leakage
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 621
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients achieving hemostasis after 2 minutes of surgery
timeFrame: Day 1 (up to 2 minutes postoperative)
measure: Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
timeFrame: Day 1 (intraoperative)
measure: Absence of air leak in lung at time of surgical closure
timeFrame: Day 1 (intraoperative)
measure: Tight closure achieved in dura mater at time of surgical closure
timeFrame: Day 1 (intraoperative)
measure: Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
timeFrame: Day 5 up to 4 weeks (postoperative)
measure: Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Duration of bile leakage after hepatobiliary surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Number of patients with postoperative urinary fistula formation after urological surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Gastrointestinal anastomosis leakage/fistula after general surgery
timeFrame: Up to 4 weeks (postoperative)
measure: Number of patients with related Adverse Events
timeFrame: Up to 4 weeks (postoperative)
Secondary outcomes:
measure: Number of Hemopatch units applied
timeFrame: Up to 4 weeks (postoperative)
measure: Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage
timeFrame: Up to 4 weeks (postoperative)
measure: Number of intraoperative transfusions by type and amount of blood product transfused
timeFrame: Day 1 (intraoperative)
measure: Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery
timeFrame: Up to 72 hours (postoperative)
measure: Surgery duration
timeFrame: Day 1 (intraoperative)
measure: Length of hospital stay
timeFrame: Up to 4 weeks (postoperative)
measure: Ease of product preparation
timeFrame: Day 1 (intraoperative)
measure: Ease of product handling
timeFrame: Day 1 (intraoperative)
measure: Assessment of product tissue adherence
timeFrame: Day 1 (intraoperative)
measure: Surgeon's overall satisfaction of product
timeFrame: Day 1 (intraoperative)
measure: Product characteristics appreciated by Surgeon
timeFrame: Day 1 (intraoperative)
measure: Product characteristics liked least by Surgeon
timeFrame: Day 1 (intraoperative)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Brno
country: Czechia
facility: Fakultní nemocnice u sv. Anny v Brně
city: Liberec
country: Czechia
facility: Krajská Nemocnice Liberec
city: Ostrava
country: Czechia
facility: Fakultní Nemocnice Ostrava
city: Praha 4
country: Czechia
facility: Thomayerova Nemocnice
city: Bergisch Gladbach
country: Germany
facility: Marien-Krankenhaus Bergisch Gladbach
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: ASKLEPIOS Klinik St. Georg
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Barcelona
country: Spain
facility: Hospital de Vall d'Hebrón
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References:
citation: 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.