CLINICAL TRIALS PROFILE FOR TRAVASOL 8.5% IN PLASTIC CONTAINER

All Clinical Trials for TRAVASOL 8.5% 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NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in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 8.5% IN PLASTIC CONTAINER

Condition Name

Condition Name for TRAVASOL 8.5% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Cancer	1
Contrast Nephropathy	1
Renal Failure	1

Condition MeSH

Condition MeSH for TRAVASOL 8.5% IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	1
Kidney Diseases	1
Colorectal Neoplasms	1

Clinical Trial Locations for TRAVASOL 8.5% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for TRAVASOL 8.5% IN PLASTIC CONTAINER
Location	Trials
Canada	1

Clinical Trial Progress for TRAVASOL 8.5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TRAVASOL 8.5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRAVASOL 8.5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for TRAVASOL 8.5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 8.5% IN PLASTIC CONTAINER
Sponsor	Trials
Queen's University	1
Canadian Institutes of Health Research (CIHR)	1
McGill University Health Center	1

Sponsor Type

Sponsor Type for TRAVASOL 8.5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	4

Clinical Trials, Market Analysis, and Projections for Travasol 8.5% in Plastic Containers

Introduction

Travasol 8.5% is a sterile amino acid solution used in parenteral nutrition, particularly for patients who cannot receive oral or enteral nutrition. This article will delve into the clinical trials, market analysis, and future projections for Travasol 8.5% in plastic containers.

Clinical Trials and Efficacy

Comparative Clinical Trials

A notable clinical trial compared Travasol 8.5% without electrolytes to FreAmine II 8.5% in patients with abnormal renal and liver function. The study involved 36 patients randomly assigned to receive either Travasol or FreAmine II. The results showed no significant differences in nitrogen balance between the two groups, although there was a slight but clinically insignificant increase in BUN levels in the Travasol group. This study concluded that both products can maintain positive nitrogen balance without significant metabolic complications[1].

Safety and Adverse Events

Another study focusing on the administration of high-osmolality amino acid solutions, including Travasol 10%, highlighted the safety profile of these infusions. The study found a low complication rate of 0.7% in 277 infusion events, with the complications being solution extravasations and thrombophlebitis in a single dog. This indicates that Travasol, when used appropriately, has a favorable safety profile[4].

Market Analysis

Current Market Size and Growth

The clinical trial packaging market, which includes the packaging of drugs like Travasol, is experiencing significant growth. The global clinical trial packaging market size was USD 2.95 billion in 2023 and is projected to reach USD 9.12 billion by 2034, growing at a CAGR of 10.80% from 2024 to 2034. This growth is driven by the increasing demand for advanced and specialized packaging solutions, particularly in regions like North America[3].

Key Market Drivers

Several factors are driving the growth of the market for clinical trial packaging, including:

• Advanced Packaging Technologies: Improvements in plastic technology, such as enhanced recyclability and the use of sustainable materials, are boosting the market. Plastics are preferred due to their versatility and ability to protect pharmaceutical products from moisture, oxygen, and light[3].
• Clinical Research Organizations: The expertise and global reach of clinical research organizations (CROs) are enhancing the efficiency and quality of clinical trials, thereby increasing the demand for specialized packaging solutions[3].
• Regulatory Compliance: Strict regulatory frameworks, especially in regions like North America, ensure high standards in clinical trial packaging, which in turn drives the market for compliant and high-quality packaging solutions[3].

Market Projections

Regional Market Trends

North America, particularly the United States, is a leading hub for clinical trials due to its advanced healthcare infrastructure and significant investment in research and development. This region is expected to continue driving the demand for clinical trial packaging, including solutions for drugs like Travasol[3].

Future Growth Opportunities

The increasing focus on patient adherence and the development of easy-to-use, informative packaging are expected to further drive the market. Key players are adopting inorganic growth strategies such as acquisitions and mergers to develop advanced clinical trial packaging solutions, which will continue to propel the market forward[3].

Packaging and Administration

Dosage and Administration

Travasol 8.5% is available in flexible plastic containers and must be used with careful aseptic technique to avoid contamination. The solution should be protected from light, and any admixed parenteral nutrition solution should be used promptly, with storage under refrigeration not exceeding 24 hours[2].

Stability and Storage

The stability of Travasol solutions is critical. Admixtures should be used within 24 hours after removal from refrigeration, and the solution should be inspected for any signs of contamination or damage before use. The plastic containers may show some opacity due to moisture absorption during sterilization, but this does not affect the solution's quality or safety[2].

Key Takeaways

• Clinical Efficacy: Travasol 8.5% has been shown to be effective in maintaining positive nitrogen balance in patients with abnormal renal and liver function.
• Market Growth: The clinical trial packaging market, including solutions for Travasol, is growing at a CAGR of 10.80% from 2024 to 2034.
• Regional Trends: North America is a significant driver of the market due to its advanced healthcare infrastructure and regulatory compliance.
• Packaging Considerations: Careful handling, storage, and administration of Travasol solutions are crucial to maintain their efficacy and safety.

FAQs

What is Travasol 8.5% used for?

Travasol 8.5% is used as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated[2].

How is Travasol 8.5% administered?

Travasol 8.5% is administered intravenously, typically through a central or peripheral catheter, and must be prepared using careful aseptic technique to avoid contamination[2].

What are the key components of Travasol 8.5%?

Travasol 8.5% contains a mixture of essential and nonessential amino acids, providing a source of nitrogen for parenteral nutrition[2].

What are the storage requirements for Travasol 8.5%?

Travasol 8.5% solutions should be protected from light and stored under refrigeration at 2° to 8°C (36° to 46°F). Admixtures should be used within 24 hours after removal from refrigeration[2].

What is the projected growth rate of the clinical trial packaging market?

The clinical trial packaging market is projected to grow at a CAGR of 10.80% from 2024 to 2034, reaching USD 9.12 billion by 2034[3].

Sources

1. Clinical Comparison of Two 8.5% Amino Acid Injection Products. PubMed.
2. Travasol: Package Insert / Prescribing Information. Drugs.com.
3. Clinical Trial Packaging Market Size, Growth Rate 10.80%. Towards Packaging.
4. Short-term parenteral infusions with high-osmolality amino acid solutions in dogs. American Veterinary Medical Association.
5. Aminosyn II 8.5% (Amino Acid Injection with Electrolytes). RxList.