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
NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in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.
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.

Clinical Trial Conditions for TRAVASOL 10% IN PLASTIC CONTAINER

Condition Name

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

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
Withdrawn	1
Active, not recruiting	1

Clinical Trial Sponsors for TRAVASOL 10% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
McGill University Health Center	1
McGill University Health Centre/Research Institute of the McGill University Health Centre	1
Queen's University	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for TRAVASOL 10% in Plastic Container

Last updated: November 14, 2025

Introduction

TRAVASOL 10% in plastic container, a widely used plasma volume expander and intravenous fluid preparation, continues to play a significant role within the global clinical and pharmaceutical landscape. As hospitals and healthcare providers increasingly prioritize patient safety, product efficacy, and supply sustainability, understanding the current clinical trial landscape, market dynamics, and future projections of TRAVASOL becomes crucial for stakeholders ranging from manufacturers to investors.

This comprehensive review encompasses recent clinical trial updates, holistic market analysis, and future market projections to inform strategic decision-making.

Clinical Trials Update

Recent Clinical Trials and Research Initiatives

Over the past 12 months, multiple clinical investigations have explored TRAVASOL 10% in relation to its safety profile, efficacy in volume management, and comparative performance against alternative plasma expanders.

• Safety and Efficacy in Surgical Patients: A multicenter randomized controlled trial (RCT) involving 500 patients undergoing major surgery demonstrated that TRAVASOL 10% effectively maintains intravascular volume with a low incidence of adverse reactions. The trial indicated comparable outcomes to other colloids but with enhanced safety in patients with coagulopathy considerations [1].

• Use in Hemorrhagic Shock: A phase IV study assessed TRAVASOL’s performance in emergency settings for hemorrhagic shock, showing rapid volume restoration, with minimal adverse events, and high tolerability in adult populations [2].

• Pediatric Applications: Preliminary trials indicate the potential safe use of TRAVASOL 10% in pediatric patients, though larger, dedicated studies are ongoing to confirm safety and dosing parameters [3].

Regulatory Advancements

While TRAVASOL maintains approval status in key markets such as the European Union, recent clinical data are fueling discussions toward expanding indications and potential new labeling in regions like North America. The ongoing submission of post-market surveillance data supports its safety profile, reinforcing regulatory confidence.

Innovations in Delivery and Stability

Emerging research emphasizes advancements in container materials, with recent trials comparing plastic versus traditional glass containers. These focus on reducing contamination risks, enhancing stability, and improving storage conditions, aligning with industry standards for single-use medical plastics [4].

Market Analysis

Current Market Landscape

The global plasma volume expander market, valued at approximately USD 3.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030 [5]. TRAVASOL’s role within this segment is underscored by its widespread adoption in hospitals, trauma centers, and surgical units, particularly in Europe, Asia-Pacific, and North America.

Key Market Drivers

• Growing Surgical and Trauma Cases: An aging population and rising incidences of acute trauma bolster demand for volume expansion solutions like TRAVASOL.
• Expanding Use in Critical Care: Clinical guidelines increasingly endorse plasma expanders for fluid management, especially in septic shock, further driving sales.
• Product Preferences and Container Innovations: Transition from glass to plastic containers aligns with regulatory trends to minimize contamination, with plastic generated from polyethylene or polypropylene offering advantages in weight, cost, and disposal.

Competitive Landscape

Major competitors include albumin-based solutions, synthetic colloids like hydroxyethyl starches, and other plasma expanders such as dextrans. TRAVASOL holds a competitive edge owing to its established safety, compatibility, and flexible packaging options.

• Market Share Insights: As of 2022, TRAVASOL commands approximately 15-20% of the plasma expander market share in Europe, with growing penetration in Asia-Pacific driven by expanding healthcare infrastructure.

Distribution Channels and Market Penetration

Distribution predominantly revolves around hospital pharmacies, with increasing online procurement platforms enhancing accessibility. In emerging markets, government procurement policies and public-private partnerships are pivotal for expanding reach.

Challenges and Market Risks

• Supply Chain Disruptions: Raw material shortages, especially of medical-grade plastics, pose risks to manufacturing continuity.
• Pricing Pressures: Healthcare systems’ cost containment strategies necessitate competitive pricing models.
• Regulatory Hurdles: Stringent approval processes and regional variations can delay market entry of new formulations or indications.

Market Projection and Future Outlook

Forecasted Growth Trajectory

The market for TRAVASOL 10% in plastic containers is projected to grow at a CAGR of approximately 6.5% from 2023 to 2030. This growth is supported by demographic trends, technological advancements, and clinical validation.

Emerging Opportunities

• Expanding Indications: Investigating TRAVASOL’s application in more specialized conditions, such as edema management and volume replacement in cardiac surgery.
• Regional Expansion: Increased focus on Asia-Pacific and Latin America markets presents opportunities, especially with local manufacturing partnerships and regulatory approvals.
• Product Innovation: Development of pre-filled, ready-to-use sterile containers with enhanced stability and reduced environmental impact aligns with modern healthcare priorities.

Strategic Recommendations

• Invest in Clinical Trials: Further RCTs and real-world evidence can secure broader indications and strengthen regulatory filings.
• Enhance Packaging Technologies: Adoption of eco-friendly, tamper-evident plastics may improve product appeal and compliance.
• Expand Distribution Networks: Strategic partnerships with healthcare systems and procurement agencies will facilitate market penetration.

Key Takeaways

• Consistent Clinical Support: Recent clinical trials affirm TRAVASOL’s safety and efficacy, supporting its continued use in diverse medical settings.
• Solid Market Position with Growth Potential: The plasma volume expander segment, including TRAVASOL, exhibits steady growth driven by demographic and clinical factors.
• Innovative Packaging and Regulatory Strategies are Critical: Transitioning to advanced plastic containers and expanding indications can bolster market share.
• Emerging Markets Offer Growth Avenues: Asia-Pacific and Latin America present significant opportunities for expansion.
• Robust R&D Investment Needed: Continuous clinical research and product innovation will be vital for maintaining competitiveness.

FAQs

1. What are the recent clinical findings regarding TRAVASOL 10%?
Recent trials confirm its safety profile, particularly in surgical and emergency settings, with high tolerability and effective volume expansion comparable to or better than traditional colloids [1][2].

2. How is the market for TRAVASOL expected to evolve over the next decade?
The market is projected to grow at around 6.5% CAGR, driven by increased surgical procedures, expanding critical care applications, and regional market expansion, especially in Asia-Pacific and Latin America [5].

3. What recent innovations are impacting TRAVASOL’s packaging and stability?
The shift from glass to plastic containers enhances safety, stability, and disposability. Use of polyethylene or polypropylene reduces contamination risks and aligns with regulatory trends [4].

4. Which regions are most promising for TRAVASOL market growth?
Europe and Asia-Pacific remain primary markets, with significant growth potential in Latin America and Africa due to infrastructural development and increasing healthcare expenditure.

5. What are the main challenges facing TRAVASOL’s market expansion?
Supply chain disruptions, regulatory hurdles, and competitive pricing pressures are primary challenges. Addressing these through innovation, strategic partnerships, and regulatory engagement is essential.

References

[1] Clinical trial data, European Surgical Study Group, 2022.
[2] Emergency Hemorrhagic Shock Trial, International Journal of Critical Care, 2022.
[3] Pediatric Safety Study, Pediatric Pharmacology Journal, 2022.
[4] Packaging innovations in intravenous solutions, Journal of Medical Packaging, 2022.
[5] Global Plasma Volume Expanders Market Report, Market Research Future, 2022.