CLINICAL TRIALS PROFILE FOR TRAVASOL 10% IN PLASTIC CONTAINER

All Clinical Trials for TRAVASOL 10% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	Canadian Institutes of Health Research (CIHR)	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Center	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk. The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF. We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.

Clinical Trial Conditions for TRAVASOL 10% IN PLASTIC CONTAINER

Condition Name

Condition Name for TRAVASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Cancer	1
Contrast Nephropathy	1
Renal Failure	1

Condition MeSH

Condition MeSH for TRAVASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Neoplasms	1
Renal Insufficiency	1
Kidney Diseases	1

Clinical Trial Locations for TRAVASOL 10% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for TRAVASOL 10% IN PLASTIC CONTAINER
Location	Trials
Canada	1

Clinical Trial Progress for TRAVASOL 10% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TRAVASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRAVASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for TRAVASOL 10% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Canadian Institutes of Health Research (CIHR)	1
McGill University Health Center	1
McGill University Health Centre/Research Institute of the McGill University Health Centre	1

Sponsor Type

Sponsor Type for TRAVASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Other	4

Clinical Trials, Market Analysis, and Projections for TRAVASOL 10% in Plastic Containers

Introduction

TRAVASOL 10% is an amino acid intravenous infusion used to offset nitrogen loss or treat nutritional imbalances in patients who cannot use the alimentary tract or have impaired gastrointestinal absorption. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this product.

Clinical Trials and Usage

TRAVASOL 10% is widely used in clinical settings for parenteral nutrition. Here are some key points regarding its clinical use:

Parenteral Infusions

Studies have shown that TRAVASOL 10% is effective in short-term parenteral infusions, particularly in cases where high-osmolality amino acid solutions are required. For instance, a study involving dogs received infusions of TRAVASOL 10% with lipids, demonstrating its safety and efficacy over extended periods[4].

Indications

TRAVASOL 10% is indicated for use in patients where the alimentary tract cannot or should not be used, or where gastrointestinal absorption of protein is impaired. It is also used in cases of extensive burns or when metabolic requirements for protein are substantially increased[5].

Market Analysis

Current Market Size

While specific data on the market size of TRAVASOL 10% alone is not readily available, the broader market for parenteral nutrition solutions is significant. The global clinical trial packaging market, which includes packaging for such solutions, is projected to grow substantially. For example, the clinical trial packaging market is expected to rise from USD 2.95 billion in 2023 to USD 9.12 billion by 2034, growing at a CAGR of 10.80%[3].

Key Players and Suppliers

The market for TRAVASOL 10% involves several key players, including manufacturers, suppliers, and distributors. These companies ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards. There are multiple suppliers offering TRAVASOL 10% in plastic containers, each adhering to stringent quality criteria[2].

Regional Demand

North America, particularly the United States, is a significant market for clinical trial packaging and parenteral nutrition solutions due to its advanced healthcare infrastructure and significant investment in research and development. This region has well-established regulatory frameworks, which drives the demand for high-quality and compliant packaging solutions[3].

Packaging and Safety

Clinical Trial Packaging

The packaging of TRAVASOL 10% is critical for maintaining the integrity and safety of the product. The use of plastic containers, such as poly (vinyl chloride) Viaflex containers or dual bag containers, ensures the solution remains sterile and nonpyrogenic. Advances in plastic technology are improving the recyclability and sustainability of these packaging materials[3].

Regulatory Compliance

Manufacturers and suppliers of TRAVASOL 10% must adhere to strict regulatory standards, including those set by the U.S. Food and Drug Administration (FDA). This ensures that the product is safe and effective for use in clinical settings[2].

Future Projections

Market Growth

The demand for parenteral nutrition solutions like TRAVASOL 10% is expected to grow, driven by increasing healthcare needs and advancements in medical technology. The broader clinical trial packaging market's projected growth indicates a favorable outlook for products that are integral to clinical trials and patient care.

Technological Advancements

Advances in packaging technology, such as the introduction of more sustainable and recyclable materials, will continue to drive the market. Additionally, innovations in packaging design aimed at enhancing patient adherence and safety will further boost demand[3].

Key Takeaways

• Clinical Use: TRAVASOL 10% is a critical component in parenteral nutrition, used in various clinical scenarios where oral nutrition is not feasible.
• Market Size: While specific data on TRAVASOL 10% is limited, the broader market for clinical trial packaging and parenteral nutrition solutions is substantial and growing.
• Packaging: The use of high-quality, compliant packaging is essential for maintaining product integrity and safety.
• Regulatory Compliance: Adherence to FDA and other regulatory standards is crucial for manufacturers and suppliers.
• Future Projections: The market is expected to grow, driven by healthcare needs and technological advancements.

FAQs

Q1: What is TRAVASOL 10% used for? TRAVASOL 10% is used as an adjunct in offsetting nitrogen loss or treating nutritional imbalances in patients where the alimentary tract cannot or should not be used, or where gastrointestinal absorption of protein is impaired.

Q2: What are the key components of TRAVASOL 10% packaging? TRAVASOL 10% is supplied in poly (vinyl chloride) Viaflex containers or dual bag containers sealed in a plastic laminated overpouch to ensure sterility and nonpyrogenicity.

Q3: How is the market for TRAVASOL 10% expected to grow? The market for TRAVASOL 10% is expected to grow as part of the broader clinical trial packaging and parenteral nutrition solutions market, driven by increasing healthcare needs and technological advancements.

Q4: What regulatory standards must TRAVASOL 10% manufacturers adhere to? Manufacturers must adhere to Good Manufacturing Practices (GMP) and regulatory standards set by the U.S. Food and Drug Administration (FDA) and other relevant authorities.

Q5: Are there any recent advancements in the packaging of TRAVASOL 10%? Yes, there are ongoing advancements in packaging technology, including the use of more sustainable and recyclable materials, which are expected to drive the market forward.

Sources

1. Travere Therapeutics Provides Corporate Update and 2025 Outlook - Travere Therapeutics
2. TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER-1 - PharmaCompass
3. Clinical Trial Packaging Market Size, Growth Rate 10.80% - Towards Packaging
4. Short-term parenteral infusions with high-osmolality amino acid ... - AVMA Journals
5. USMP7817-0018 DHCP letter for Thetford Synthamin 2017 - Baxter