Dura Mater Nick Cut or TearNCT03392662
Hemopatch Performance Evaluation: A Prospective Observational Registry
An observational study of Dura Mater Nick Cut or Tear and Hemostatis, run by Baxter Healthcare Corporation at 15 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- How many people
- 621 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 29 Nov 2017to 28 Jan 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain5 sites
Hospital de Vall d'Hebrón
Barcelona, 8035
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocio
Seville, 41013
Czechia4 sites
Fakultní nemocnice u sv. Anny v Brně
Brno, 65691
Krajská Nemocnice Liberec
Liberec, 46063
Fakultní Nemocnice Ostrava
Ostrava, 70852
Thomayerova Nemocnice
Prague, 14059
Germany4 sites
Marien-Krankenhaus Bergisch Gladbach
Bergisch Gladbach
Deutsches Herzzentrum Berlin
Berlin, 13353
ASKLEPIOS Klinik St. Georg
Hamburg, 20099
Universitaetsklinikum Regensburg
Regensburg, 93042
About this study
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.
- Being tested
- Hemopatch
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
Patients received product at the discretion of their surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch Sealant Use with Hepatobiliary Surgery | Not described Receives: Device: Hemopatch | |
| Hemopatch Sealant Use with General Surgery | Not described Receives: Device: Hemopatch | |
| Hemopatch Sealant Use with Lung Surgery | Not described Receives: Device: Hemopatch | |
| Hemopatch Sealant Use with Cardiovascular Surgery | Not described Receives: Device: Hemopatch | |
| Hemopatch Sealant Use with Neurological/Spinal Surgery | Not described Receives: Device: Hemopatch | |
| Hemopatch Sealant Use with Urologic Surgery | Not described Receives: Device: Hemopatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving hemostasis after 2 minutes of surgery
Measured: Day 1 (up to 2 minutes postoperative)
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
Measured: Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure
Measured: Day 1 (intraoperative)
Tight closure achieved in dura mater at time of surgical closure
No leak after inspection per local standard of care
Measured: Day 1 (intraoperative)
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
Measured: Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
Measured: Up to 4 weeks (postoperative)
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
Measured: Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery
Measured: Up to 4 weeks (postoperative)
Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery
External or internal accumulation including pseudomeningocele
Measured: Up to 4 weeks (postoperative)
Number of patients with postoperative urinary fistula formation after urological surgery
Measured: Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery
Measured: Up to 4 weeks (postoperative)
Number of patients with related Adverse Events
Measured: Up to 4 weeks (postoperative)
Secondary outcomes (12)
Number of Hemopatch units applied
Measured: Up to 4 weeks (postoperative)
Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage
Measured: 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.
Measured: 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.
Measured: Up to 72 hours (postoperative)
Surgery duration
Measured: Day 1 (intraoperative)
Length of hospital stay
Intensive Care Unit (ICU) and hospital
Measured: Up to 4 weeks (postoperative)
Ease of product preparation
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Ease of product handling
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Assessment of product tissue adherence
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Surgeon's overall satisfaction of product
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Product characteristics appreciated by Surgeon
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Product characteristics liked least by Surgeon
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Measured: Day 1 (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start29 Nov 2017
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dura Mater Nick Cut or TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 621 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392662
- Sponsor's protocol ID
- BXU011443
- Status last verified
- Nov 2022
- First submitted
- 19 Dec 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 35986865
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemopatch Performance Evaluation: A Prospective Observational Registry
- ClinicalTrials.gov ID
- NCT03392662
- Acronym / sponsor ID
- BXU011443
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopatchPatients received product at the discretion of their surgeon. | Device | 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 |
Primary outcome
Percentage of patients achieving hemostasis after 2 minutes of surgery
Time frame: Day 1 (up to 2 minutes postoperative)
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
Time frame: Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure
Time frame: Day 1 (intraoperative)
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
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
Time frame: Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
Time frame: Up to 4 weeks (postoperative)
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
Time frame: Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery
Time frame: Up to 4 weeks (postoperative)
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
Number of patients with postoperative urinary fistula formation after urological surgery
Time frame: Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery
Time frame: Up to 4 weeks (postoperative)
Number of patients with related Adverse Events
Time frame: Up to 4 weeks (postoperative)
12 secondary outcomes
Number of Hemopatch units applied
Time frame: Up to 4 weeks (postoperative)
Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage
Time frame: Up to 4 weeks (postoperative)
Number of intraoperative transfusions by type and amount of blood product transfused
Time frame: Day 1 (intraoperative)
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)
Surgery duration
Time frame: Day 1 (intraoperative)
Length of hospital stay
Time frame: Up to 4 weeks (postoperative)
Ease of product preparation
Time frame: Day 1 (intraoperative)
Ease of product handling
Time frame: Day 1 (intraoperative)
Assessment of product tissue adherence
Time frame: Day 1 (intraoperative)
Surgeon's overall satisfaction of product
Time frame: Day 1 (intraoperative)
Product characteristics appreciated by Surgeon
Time frame: Day 1 (intraoperative)
Product characteristics liked least by Surgeon
Time frame: Day 1 (intraoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 35986865Lombardo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dura Mater Nick Cut or Tear and Hemostatis, run by Baxter Healthcare Corporation at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Czechia, Germany, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving hemostasis after 2 minutes of surgery (time frame: Day 1 (up to 2 minutes postoperative)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.