CLINICAL TRIALS PROFILE FOR CARDIOPLEGIC IN PLASTIC CONTAINER

All Clinical Trials for Cardioplegic In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00934596 ↗	CO2 Versus Lund De-airing Technique in Heart Surgery	Completed	Lund University	N/A	2009-06-01	To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air. To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
NCT01123525 ↗	Adenosine Cardioplegia; Improved Cardioprotection?	Completed	University Hospital of North Norway	Phase 1/Phase 2	2010-04-01	60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.
NCT01401140 ↗	Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis	Completed	Association AIRE (FR)	Phase 3	2010-06-01	An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
NCT01401140 ↗	Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis	Completed	Jazz Pharmaceuticals	Phase 3	2010-06-01	An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
NCT01401140 ↗	Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis	Completed	Centre Hospitalier Universitaire de Saint Etienne	Phase 3	2010-06-01	An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue. High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

Clinical Trial Conditions for Cardioplegic In Plastic Container

Condition Name

Condition Name for Cardioplegic In Plastic Container
Intervention	Trials
Coronary Artery Disease (CAD)	2
Heart Defects, Congenital	2
Cardioplegia Solution Adverse Reaction	2
Congenital Heart Disease	2

Condition MeSH

Condition MeSH for Cardioplegic In Plastic Container
Intervention	Trials
Heart Defects, Congenital	6
Heart Diseases	5
Myocardial Ischemia	4
Coronary Artery Disease	4

Clinical Trial Locations for Cardioplegic In Plastic Container

Trials by Country

Trials by Country for Cardioplegic In Plastic Container
Location	Trials
Germany	7
Egypt	6
Spain	3
United States	3
China	1

Trials by US State

Trials by US State for Cardioplegic In Plastic Container
Location	Trials
Texas	2
Michigan	1

Clinical Trial Progress for Cardioplegic In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Cardioplegic In Plastic Container
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Cardioplegic In Plastic Container
Clinical Trial Phase	Trials
Completed	9
Unknown status	8
Recruiting	5

Clinical Trial Sponsors for Cardioplegic In Plastic Container

Sponsor Name

Sponsor Name for Cardioplegic In Plastic Container
Sponsor	Trials
Ain Shams University	2
Dr. F. Köhler Chemie GmbH	2
Assiut University	2

Sponsor Type

Sponsor Type for Cardioplegic In Plastic Container
Sponsor	Trials
Other	29
Industry	4

Cardioplegic Solution in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Cardioplegic solutions are crucial in cardiac surgery, providing a quiet and bloodless surgical field by arresting the heart's electromechanical activity. When packaged in plastic containers, these solutions must meet stringent standards for safety, efficacy, and compatibility. Here, we delve into the clinical trials, market analysis, and future projections for cardioplegic solutions in plastic containers.

Clinical Pharmacology of Cardioplegic Solutions

Cardioplegic solutions, when cooled and instilled into the coronary artery vasculature, induce prompt cardiac arrest and help maintain cellular integrity. These solutions typically contain electrolytes, potassium, magnesium, and calcium to combat ischemic acidosis and protect the myocardial membrane[1].

Clinical Trials: Comparative Studies

Clinical studies have compared the protective effects of different types of cardioplegic solutions. For instance, a study comparing crystalloid and blood-based St. Thomas' Hospital cardioplegic solution No. 1 found that while both solutions provided similar myocardial protection, the blood-based solution maintained higher levels of creatine phosphate and facilitated a quicker return to spontaneous sinus rhythm[4].

Key Findings

• Myocardial Protection: Blood-based cardioplegic solutions showed better preservation of creatine phosphate levels compared to crystalloid solutions.
• Clinical Outcomes: Patients receiving blood-based solutions had a higher rate of return to spontaneous sinus rhythm and faster recovery of left ventricular function.
• Haemodynamic Data: No significant differences were observed in peri-operative and post-operative haemodynamic data between the two groups.

Market Analysis: Medical Plastics

The packaging of cardioplegic solutions in plastic containers is a critical aspect of their market analysis. The global medical plastics market is projected to grow significantly, driven by the increasing demand for advanced medical devices and packaging.

Market Size and Growth

• The global medical plastics market was estimated at USD 52.9 billion in 2023 and is expected to grow at a CAGR of 5.6% from 2024 to 2030[2].
• North America dominated the market with a share of over 33% in 2023, driven by the rising demand for medical devices and pharmaceutical packaging.

Key Applications

• Medical Device Packaging: Plastics like polyethylene, polypropylene, and polycarbonate are increasingly used for packaging medical devices.
• Orthopedic Implant Packaging: Thermoplastic polyurethane (TPU) and cross-linked polyethylene (XLPE) are preferred for their abrasion and puncture resistance[2].

Packaging Considerations

Cardioplegic solutions in plastic containers must adhere to strict quality and safety standards.

Material Compatibility

• The containers must be made from materials that are compatible with the solution and do not react with it. For example, cardioplegic solutions are often packaged in non-PVC, non-DEHP, sterile containers[1].

Sterilization Methods

• The packaging material should be compatible with multiple sterilization methods, such as gamma and ethylene oxide (ETO) sterilization, to ensure the solution remains sterile until use[2].

Market Projections

The demand for cardioplegic solutions in plastic containers is expected to rise in line with the growing need for advanced cardiac surgical procedures.

Increasing Demand for Cardiac Surgeries

• The prevalence of cardiovascular diseases and the aging population are driving the demand for cardiac surgeries, thereby increasing the need for cardioplegic solutions[2].

Technological Advancements

• Advances in medical plastics and packaging technologies are expected to enhance the safety, efficacy, and convenience of cardioplegic solutions, further boosting their market[2].

Impact of COVID-19

The COVID-19 pandemic has accelerated the adoption of advanced medical technologies, including those related to cardioplegic solutions.

Shift to Home Healthcare

• The pandemic has increased the preference for home healthcare over hospital care, which, in turn, has driven the demand for medical devices and related packaging solutions[2].

Virtual Clinical Trials

• The pandemic has also spurred the use of in silico clinical trials, which could potentially influence the development and testing of new cardioplegic solutions, although this is more relevant to pharmaceuticals than to the packaging of existing solutions[3].

Key Takeaways

• Clinical Efficacy: Cardioplegic solutions in plastic containers have been shown to be effective in cardiac surgeries, with blood-based solutions offering some advantages over crystalloid solutions.
• Market Growth: The global medical plastics market is expected to grow significantly, driven by the increasing demand for medical devices and packaging.
• Packaging Standards: The packaging of cardioplegic solutions must meet stringent quality and safety standards, including compatibility with sterilization methods.
• Technological Advancements: Advances in medical plastics and packaging technologies are expected to enhance the safety and efficacy of cardioplegic solutions.

FAQs

What are the key components of cardioplegic solutions?

Cardioplegic solutions typically contain electrolytes, potassium, magnesium, and calcium to induce cardiac arrest and protect the myocardial membrane[1].

How do blood-based and crystalloid cardioplegic solutions compare?

Blood-based solutions maintain higher levels of creatine phosphate and facilitate a quicker return to spontaneous sinus rhythm compared to crystalloid solutions[4].

What are the packaging requirements for cardioplegic solutions?

The packaging must be made from non-reactive materials, be compatible with multiple sterilization methods, and ensure the solution remains sterile until use[1][2].

How has the COVID-19 pandemic impacted the market for cardioplegic solutions?

The pandemic has increased the demand for home healthcare and driven the adoption of advanced medical technologies, including those related to cardioplegic solutions[2].

What is the projected growth rate of the medical plastics market?

The global medical plastics market is expected to grow at a CAGR of 5.6% from 2024 to 2030[2].

Sources

1. Drugs.com: Cardioplegic: Package Insert / Prescribing Information.
2. Grandview Research: Medical Plastics Market Size, Share & Growth Report, 2030.
3. Mordor Intelligence: Global In Silico Clinical Trials Market Size.
4. Oxford University Press: Clinical comparative study between crystalloid and blood-based St. Thomas' Hospital cardioplegic solution No. 1.
5. Pharmacompass: Cardioplegic In Plastic Container-1.