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Completed

NCT Number: NCT03392662

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.

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Key information

Conditions

Dura Mater Nick Cut or Tear Air Leakage Body Fluid Leakage Hemostatis Lacerations Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Universitaetsklinik, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

HEMOPATCH

Device

Patients received product at the discretion of their surgeon.

Primary outcomes

  1. Percentage of patients achieving hemostasis after 2 minutes of surgery

    Time frame: Day 1 (up to 2 minutes postoperative)

  2. Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure

    Time frame: Day 1 (intraoperative)

  3. Absence of air leak in lung at time of surgical closure

    Time frame: Day 1 (intraoperative)

  4. Tight closure achieved in dura mater at time of surgical closure

    Time frame: Day 1 (intraoperative)

    No leak after inspection per local standard of care

  5. Number of patients with chest tube drainage >=5 days after thoracic/lung surgery

    Time frame: Day 5 up to 4 weeks (postoperative)

  6. Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery

    Time frame: Up to 4 weeks (postoperative)

  7. Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery

    Time frame: Up to 4 weeks (postoperative)

  8. Duration of bile leakage after hepatobiliary surgery

    Time frame: Up to 4 weeks (postoperative)

  9. Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery

    Time frame: Up to 4 weeks (postoperative)

    External or internal accumulation including pseudomeningocele

  10. Number of patients with postoperative urinary fistula formation after urological surgery

    Time frame: Up to 4 weeks (postoperative)

  11. Gastrointestinal anastomosis leakage/fistula after general surgery

    Time frame: Up to 4 weeks (postoperative)

  12. Number of patients with related Adverse Events

    Time frame: Up to 4 weeks (postoperative)

Secondary outcomes

  1. Number of Hemopatch units applied

    Time frame: Up to 4 weeks (postoperative)

  2. Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage

    Time frame: Up to 4 weeks (postoperative)

  3. Number of intraoperative transfusions by type and amount of blood product transfused

    Time frame: Day 1 (intraoperative)

    Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.

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

    Time frame: Up to 72 hours (postoperative)

    Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.

  5. Surgery duration

    Time frame: Day 1 (intraoperative)

  6. Length of hospital stay

    Time frame: Up to 4 weeks (postoperative)

    Intensive Care Unit (ICU) and hospital

  7. Ease of product preparation

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

  8. Ease of product handling

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

  9. Assessment of product tissue adherence

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

  10. Surgeon's overall satisfaction of product

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

  11. Product characteristics appreciated by Surgeon

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

  12. Product characteristics liked least by Surgeon

    Time frame: Day 1 (intraoperative)

    Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2018
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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