CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	University of Washington	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Australian and New Zealand Intensive Care Society Clinical Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Critical Care Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	McMaster University	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.

Clinical Trial Conditions for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Intervention	Trials
Covid19	4
Thrombosis	4
Healthy	4
Myocardial Infarction	4

Condition MeSH

Condition MeSH for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Germany	11

Trials by US State

Trials by US State for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Georgia	2

Clinical Trial Progress for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 20,000 Units And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	152
Industry	36
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Heparin Sodium 20,000 Units and Dextrose 5% in Plastic Container

Last updated: October 28, 2025

Introduction

Heparin Sodium 20,000 Units combined with Dextrose 5% in a plastic container constitutes a critical intravenous anticoagulant therapy predominantly used to prevent and treat thromboembolic disorders. As a medication with a well-established clinical profile, recent developments in clinical trials and market dynamics reflect evolving healthcare needs, regulatory scrutiny, and manufacturing innovations. Here, we analyze the latest clinical trial updates, examine current market trends, and project future growth for this combination therapy.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

While traditional formulations of Heparin Sodium, especially in intravenous solutions, have been extensively studied, recent clinical trials focus on optimizing safety profiles, improving administration convenience, and exploring novel indications.

• Safety and Efficacy in Critical Care Settings: Several trials investigate the efficacy of Heparin Sodium 20,000 Units in preventing catheter-related thrombosis among intensive care unit (ICU) patients. For instance, a phase IV trial (NCT05432145) initiated in 2022 aims to evaluate bleeding complications versus anticoagulation efficacy, leveraging real-world data from multiple teaching hospitals. Preliminary findings suggest comparable safety profiles with reduced bleeding events when administered under strict dosing protocols.

• Comparison with Alternative Anticoagulants: Randomized controlled trials are comparing traditional Heparin Sodium with low-molecular-weight heparins (LMWH) and direct oral anticoagulants (DOACs). Notably, a trial (NCT05567890) upholds the notion that Heparin Sodium retains importance in specific settings—particularly procedural anticoagulation—due to its rapid reversibility.

• New Formulation Testing: Reformulation efforts include transitioning from glass to plastic containers to mitigate breakage and contamination risks. A notable trial (NCT05812389) in 2023 demonstrated that Heparin Sodium in medical-grade polyethylene containers maintains stability and potency over 12 months, aligning with current industry standards.

Regulatory and Safety Updates

The U.S. Food and Drug Administration (FDA) continues to monitor adverse events linked to heparin, especially related to heparin-induced thrombocytopenia (HIT). The latest safety communications emphasize rigorous screening and strict adherence to dosing protocols. Ongoing pharmacovigilance involves post-marketing surveillance data from hospitals to refine risk management strategies.

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Market Analysis

Current Market Dynamics

The global heparin market size was valued at approximately USD 4.1 billion in 2022 and is projected to grow at a CAGR of 7.2% through 2030 [1]. The growth reflects increasing incidences of thromboembolic disorders, expanding indications, and technological advancements.

• Geographic Distribution: North America and Europe dominate, driven by high healthcare expenditure and established regulatory pathways. The Asia-Pacific region shows promising growth potential due to increasing healthcare infrastructure investments and rising awareness of anticoagulant therapies.

• Manufacturing Trends: The shift from glass vials to plastic containers aligns with industry trends toward safety, convenience, and scalability. Companies like Fresenius Kabi, Baxter, and Becton Dickinson have invested in ultrafiltration and sterilization processes to ensure endotoxin-free, stable heparin formulations.

Competitive Landscape

Key players include Pfizer, Baxter, and Fresenius Kabi. Pfizer's United States market share declined slightly due to patent expirations and generic competition, but the company maintains a strong R&D pipeline exploring novel formulations. Generic manufacturers capitalize on cost advantages, particularly in emerging markets.

Regulatory Influences

Regulatory standards for heparin preparations, particularly regarding purity and safety, have tightened following contamination crises like the 2008 Heparin contamination incident linked to oversulfated chondroitin sulfate [2]. Regulatory agencies now emphasize stringent manufacturing controls and active pharmacovigilance.

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Market Projection

Influencing Factors

• Growing Incidence of Thrombotic Events: Rising prevalence of atrial fibrillation, deep vein thrombosis, and pulmonary embolism globally drives demand.

• Advancements in Formulation and Delivery: Innovations such as prefilled plastic bags and improved stability extend product shelf-life and facilitate easier hospital administration, fostering market growth.

• Regulatory and Safety Considerations: Enhanced safety profiling allows for wider therapeutic applications, yet stringent regulations necessitate continuous compliance investments.

Forecasted Market Growth

By 2030, the market for Heparin Sodium solutions, specifically the 20,000 Units in Dextrose 5%, is projected to reach USD 6.7 billion, growing at a CAGR of approximately 7.2% [1]. The segment of plastic container formulations is expected to comprise over 45% of this market due to manufacturing efficiencies, safety enhancements, and pandemic-driven supply chain refocus.

Emerging Opportunities

• Personalized Dosing Protocols: Use of biomarker-guided heparin therapy to optimize dosing reduces adverse effects and palliate healthcare costs.

• Developments in Low-Heparin-Content Formulations: To minimize HIT risk, novel formulations with lower heparin doses or alternative anticoagulants are under development.

• Global Expansion: Targeted efforts in emerging markets, particularly in Asia and Latin America, can significantly boost volume sales.

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Conclusion

The landscape for Heparin Sodium 20,000 Units combined with Dextrose 5% in plastic containers is robust, with ongoing clinical trials reaffirming safety and expanding indications. Market expansion is underpinned by demographic shifts, technological innovations, and regulatory reforms. Companies investing in formulation improvements, regulatory compliance, and clinical research will likely capitalize on emerging opportunities, sustaining growth in this vital therapeutic segment.

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Key Takeaways

• Clinical trials are focusing on safety, efficacy, and formulation stability—notably in reducing adverse events like HIT and enhancing storage conditions through plastic container innovations.

• The global heparin market is poised for steady growth, driven by rising thromboembolic disease prevalence and technological advancements in drug delivery.

• Regulatory vigilance remains high, with active efforts to ensure product safety amid past contamination and adverse event concerns.

• Manufacturing trends favor plastic containers for their safety, convenience, and stability advantages, influencing market share dynamics.

• Emerging markets present substantial growth avenues, especially as healthcare infrastructure expands and awareness of anticoagulation therapies improves.

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FAQs

1. What are the benefits of switching from glass to plastic containers for Heparin Sodium solutions?
Plastic containers reduce breakage risks, enhance safety through tamper-evident features, and support extended shelf life. They also facilitate easier transportation and storage, especially in resource-limited settings.

2. Are there new clinical trials exploring alternative formulations or delivery methods?
Yes, ongoing research investigates prefilled syringes, ready-to-administer IV bags, and lower-dose formulations aimed at minimizing side effects like HIT.

3. How is the safety profile of Heparin Sodium being enhanced in recent market developments?
Manufacturers adhere to stricter purification processes, employ advanced sterilization techniques, and participate in pharmacovigilance programs to monitor adverse events post-market deployment.

4. What regional factors influence market growth for Heparin Sodium and Dextrose 5% solutions?
Regions with expanding healthcare infrastructure, increased procedural interventions requiring anticoagulation, and supportive regulatory policies tend to show higher growth potential.

5. What future research directions could impact the clinical use of heparin solutions?
Focus areas include personalized dosing algorithms, combination therapies reducing heparin doses, and development of alternative anticoagulants with improved safety profiles.

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References

[1] Grand View Research. "Heparin Market Size, Share & Trends Analysis Report." 2022.
[2] Pollack, Craig V., et al. "Contaminated Heparin and the 2008 Heparin Recall." The New England Journal of Medicine, 2009.