CHD - Coronary Heart DiseaseHemopatchNCT03340090
Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
A study testing Medical Device Hemopatch-PEG-coated collagen patch in people with CHD - Coronary Heart Disease, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHD - Coronary Heart Disease
- What is being tested?
- Medical Device Hemopatch-PEG-coated collagen patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 20 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary heart disease CHD (mammary harvesting)
- age>18
- informed consent
Who cannot join
- any condition that exclude patient from standard CABG procedure
- additional cardiac procedure to be conducted on subject in addition to CABG
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lodz
Lodz, Łódź Voivodeship
Michal Krejca
About this study
The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent haemorrhage after IMA harvesting and sternum closure.
- Conditions
- CHD - Coronary Heart Disease
- Being tested
- Medical Device Hemopatch-PEG-coated collagen patch
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Hemopatch-PEG-coated collagen patchDevice
Two pieces of PEG-coated collagen patch Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of LIMA harvesting and second piece of Hemopatch will be placed beneath the sternum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | First group of patients will undergo standard CABG procedure in CPB. In addition, two pieces of Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of left internal mammary artery (LIMA) harvesting and second piece of Hemopatch will be placed beneath the sternum. Receives: Device: Medical Device Hemopatch-PEG-coated collagen patch |
| Control | No intervention | Second group of patients will undergo standard CABG procedure in CPB only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative drainage (ml)
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
Measured: measured 48 hours after surgery
need for blood transfusion (number of blood units transfused)
the total amount of blood passed to the patient
Measured: measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
The number of reoperations
The necessity of performing retoractomy due to excessive drainage or cardiac tamponade
Measured: observed until 7 days after surgery
Secondary outcomes (4)
level of hemoglobin (g/dl)
level of hemoglobin tested in perioperative time frame
Measured: after surgery until hospital discharge (on avarage until 7th day after surgery)
length of Intensive Care Unit stay (h)
length of Intensive Care Unit stay measured in hours
Measured: on average 48 hours after surgery
hospital stay (days)
length of hospital stay after surgery
Measured: after surgery until hospital discharge (on average until 7th day after surgery)
treatment cost (USD)
total treatment cost measured in both experimental and control group from hospital admission to hospital discharge
Measured: from patient hospital admission to hospital discharge ( on average 8-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start20 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Coronary Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomized groups of 100 patients will undergo standard CABG procedure in Cardio-Pulmonary Bypass (CPB). In first group (100 patients) two pieces of Hemopatch will be applied in one patient. Second group is the control group without above described intervention.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Michal Krejca, PhD, Md, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340090
- Sponsor's protocol ID
- 022017
- Acronym
- Hemopatch
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03340090
- Acronym / sponsor ID
- Hemopatch / 022017
- Conditions
- CHD - Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 Nov 2017 (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.
The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent haemorrhage after IMA harvesting and sternum closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomized groups of 100 patients will undergo standard CABG procedure in Cardio-Pulmonary Bypass (CPB). In first group (100 patients) two pieces of Hemopatch will be applied in one patient. Second group is the control group without above described intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Medical Device Hemopatch-PEG-coated collagen patchFirst group of patients will undergo standard CABG procedure in CPB. In addition, two pieces of Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of left internal mammary artery (LIMA) harvesting and second piece of Hemopatch will be placed beneath the sternum. |
| Control | No intervention | –Second group of patients will undergo standard CABG procedure in CPB only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- coronary heart disease CHD (mammary harvesting)
- age>18
- informed consent
Key exclusion criteria (2 listed)
- any condition that exclude patient from standard CABG procedure
- additional cardiac procedure to be conducted on subject in addition to CABG
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 |
|---|---|---|
| Medical Device Hemopatch-PEG-coated collagen patchTwo pieces of PEG-coated collagen patch Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of LIMA harvesting and second piece of Hemopatch will be placed beneath the sternum. | Device | Intervention |
Primary outcome
Total postoperative drainage (ml)
Time frame: measured 48 hours after surgery
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
need for blood transfusion (number of blood units transfused)
Time frame: measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
the total amount of blood passed to the patient
The number of reoperations
Time frame: observed until 7 days after surgery
The necessity of performing retoractomy due to excessive drainage or cardiac tamponade
4 secondary outcomes
level of hemoglobin (g/dl)
Time frame: after surgery until hospital discharge (on avarage until 7th day after surgery)
length of Intensive Care Unit stay (h)
Time frame: on average 48 hours after surgery
hospital stay (days)
Time frame: after surgery until hospital discharge (on average until 7th day after surgery)
treatment cost (USD)
Time frame: from patient hospital admission to hospital discharge ( on average 8-10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
Related trials for CHD - Coronary Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
Michal Krejca, PhD, Md principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Hemopatch-PEG-coated collagen patch in people with CHD - Coronary Heart Disease, run by Medical University of Lodz at 1 site in Poland.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał Krejca, PhD,Md (+48422014460, michal.krejca@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative drainage (ml) (time frame: measured 48 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2019.