Cardiopulmonary BypassIMICPBSNCT04476342
Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility
A study testing minimal invasive cardiopulmonary bypass (MICPB) system in people with Cardiopulmonary Bypass and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Research objective: (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Surgery
- What is being tested?
- minimal invasive cardiopulmonary bypass (MICPB) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient weight ≤60kg;
- Age ≥18 years old;
- The patient underwent cardiac arrest surgery.
Who cannot join
- Heart transplant patients;
- Emergency cardiac surgery patients;
- Patients who had been assisted by extracorporeal membrane oxygenator (ECMO) or assisted by left heart before operation
- Left ventricular ejection fraction (LVEF) < 30%;
- Patients with coagulation dysfunction before surgery;
- Patients with preoperative hepatic and renal insufficiency;
- Recent cerebrovascular accident patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Anqi Li, master, 86-13706719453, 13706719453@163.com
About this study
Research objective:
(1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients.(3) To explore the influence of integrated minimally invasive extracorporeal circulation system on blood dilution of patients.(4) To explore the influence of integrated minimally invasive extracorporeal circulation system on inflammatory response in patients.
Read more
- Clinical research methods: A prospective, single-blind, randomized controlled study was designed. 80 patients should be included.Clinical study grouping: The control group was conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound potassium, calcium and magnesium +25ml normal saline).
Research method:
A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb), hematokrit (Hct), and blood lactate values of the two groups of patients were measured and analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume were collected during CPB in the two groups of patients, and the data of the two groups were statistically analyzed.To investigate the effects of integrated minimally invasive extracorporeal circulation system on inflammatory response indicators white blood cell count (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3) To investigate the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital mortality of patients in the two groups were statistically analyzed.
Read the detailed description
Research objective:
(1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients.(3) To explore the influence of integrated minimally invasive extracorporeal circulation system on blood dilution of patients.(4) To explore the influence of integrated minimally invasive extracorporeal circulation system on inflammatory response in patients.
Research and development of integrated minimally invasive extracorporeal circulation system
(1) Appropriate CPB tubes should be determined according to clinical needs. Adopt 3/8 inch vein tubes and elevate the position of blood storage tank to reduce the length of the tubes and precharge.The piping jacket shall include the main pump pipe, the infusion pipe, the platform package (static and static vessels), the left and right core suction pipe, and the negative pressure suction pipe.The total precharge should be kept at about 800ml (284ml static precharge of the self-equipped micro-plug oxygenator, and about 500ml precharge of the pipeline and stopping liquid perfusion system).(2) Cooperate with integrated membrane oxygenator manufacturers in the design of pipelines to form a wrapper that integrates membrane oxygenator and pipeline.Among them, oxygenator and pipeline should be well connected in the sheath.
Clinical research methods:
A prospective, single-blind, randomized controlled study was designed. 80 patients should be included.Clinical study grouping: The control group was CCPB group, which was equipped with ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline).
Research method:
A: Before, in, and after CPB blood collection, Hb, Hct, and blood lactate values of the two groups of patients were measured and analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume were collected during CPB in the two groups of patients, and the data of the two groups were statistically analyzed.To investigate the effects of integrated minimally invasive extracorporeal circulation system on inflammatory response indicators WBC, CRP, IL-6, TNF- and C3a in patients before (T0), CPB (T1) and 2 hours after CPB (T2), blood samples were collected from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF- and C3a were determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3) To investigate the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital mortality of patients in the two groups were statistically analyzed.
- Conditions
- Cardiopulmonary Bypass, Cardiac Surgery
- Being tested
- minimal invasive cardiopulmonary bypass (MICPB) system
- Keywords
- cardiopulmonary bypass, minimal invasive, cardiac surgery, blood compatibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal invasive cardiopulmonary bypass (MICPB) systemDevice
The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline)
| Study group | Role | What they receive |
|---|---|---|
| MICPB group | Experimental | The experimental group is minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline). Receives: Device: minimal invasive cardiopulmonary bypass (MICPB) system |
| CCPB group | No intervention | The control group was conventional cardiopulmonary bypass (CCPB) group, using ordinary oxygenator, microemboli filter, and 4:1 cardioplegia solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion volume
Blood transfusion volume during cardiac surgery
Measured: through surgery completion, an average of 5 hours
Secondary outcomes (1)
ICU duration
Duration of ICU Stay
Measured: Duration of ICU stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476342
- Sponsor's protocol ID
- 2019-044
- Acronym
- IMICPBS
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility
- ClinicalTrials.gov ID
- NCT04476342
- Acronym / sponsor ID
- IMICPBS / 2019-044
- Conditions
- Cardiopulmonary Bypass, Cardiac Surgery
- Keywords
- cardiopulmonary bypass, minimal invasive, cardiac surgery, blood compatibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jul 2020 (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.
Research objective:
(1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients.(3) To explore the influence of integrated minimally invasive extracorporeal circulation system on blood dilution of patients.(4) To explore the influence of integrated minimally invasive extracorporeal circulation system on inflammatory response in patients.
- Clinical research methods: A prospective, single-blind, randomized controlled study was designed. 80 patients should be included.Clinical study grouping: The control group was conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound potassium, calcium and magnesium +25ml normal saline).
Research method:
A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb), hematokrit (Hct), and blood lactate values of the two groups of patients were measured and analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume were collected during CPB in the two groups of patients, and the data of the two groups were statistically analyzed.To investigate the effects of integrated minimally invasive extracorporeal circulation system on inflammatory response indicators white blood cell count (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3) To investigate the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital mortality of patients in the two groups were statistically analyzed.
Detailed description
Research objective:
(1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients.(3) To explore the influence of integrated minimally invasive extracorporeal circulation system on blood dilution of patients.(4) To explore the influence of integrated minimally invasive extracorporeal circulation system on inflammatory response in patients.
Research and development of integrated minimally invasive extracorporeal circulation system
(1) Appropriate CPB tubes should be determined according to clinical needs. Adopt 3/8 inch vein tubes and elevate the position of blood storage tank to reduce the length of the tubes and precharge.The piping jacket shall include the main pump pipe, the infusion pipe, the platform package (static and static vessels), the left and right core suction pipe, and the negative pressure suction pipe.The total precharge should be kept at about 800ml (284ml static precharge of the self-equipped micro-plug oxygenator, and about 500ml precharge of the pipeline and stopping liquid perfusion system).(2) Cooperate with integrated membrane oxygenator manufacturers in the design of pipelines to form a wrapper that integrates membrane oxygenator and pipeline.Among them, oxygenator and pipeline should be well connected in the sheath.
Clinical research methods:
A prospective, single-blind, randomized controlled study was designed. 80 patients should be included.Clinical study grouping: The control group was CCPB group, which was equipped with ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline).
Research method:
A: Before, in, and after CPB blood collection, Hb, Hct, and blood lactate values of the two groups of patients were measured and analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume were collected during CPB in the two groups of patients, and the data of the two groups were statistically analyzed.To investigate the effects of integrated minimally invasive extracorporeal circulation system on inflammatory response indicators WBC, CRP, IL-6, TNF- and C3a in patients before (T0), CPB (T1) and 2 hours after CPB (T2), blood samples were collected from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF- and C3a were determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3) To investigate the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital mortality of patients in the two groups were statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICPB group | Experimental | Device: minimal invasive cardiopulmonary bypass (MICPB) systemThe experimental group is minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline). |
| CCPB group | No intervention | –The control group was conventional cardiopulmonary bypass (CCPB) group, using ordinary oxygenator, microemboli filter, and 4:1 cardioplegia solution. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient weight ≤60kg;
- Age ≥18 years old;
- The patient underwent cardiac arrest surgery.
Key exclusion criteria (7 listed)
- Heart transplant patients;
- Emergency cardiac surgery patients;
- Patients who had been assisted by extracorporeal membrane oxygenator (ECMO) or assisted by left heart before operation
- Left ventricular ejection fraction (LVEF) < 30%;
- Patients with coagulation dysfunction before surgery;
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 |
|---|---|---|
| minimal invasive cardiopulmonary bypass (MICPB) systemThe experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline) | Device | MICPB group |
Primary outcome
Blood transfusion volume
Time frame: through surgery completion, an average of 5 hours
Blood transfusion volume during cardiac surgery
1 secondary outcome
ICU duration
Time frame: Duration of ICU stay, an average of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal invasive cardiopulmonary bypass (MICPB) system in people with Cardiopulmonary Bypass and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 7 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 20 Jul 2020. 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 China. 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 Anqi Li, master (86-13706719453, 13706719453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood transfusion volume (time frame: through surgery completion, an average of 5 hours). 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 20 Jul 2020.