CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Heparin Sodium 25,000 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.

Clinical Trial Conditions for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container
Intervention	Trials
Thrombosis	4
Myocardial Infarction	4
Healthy	4
Covid19	4

Condition MeSH

Condition MeSH for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	7
COVID-19	6

Clinical Trial Locations for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Spain	11

Trials by US State

Trials by US State for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 25,000 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 25,000 Units And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 25,000 Units And Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Heparin Sodium 25,000 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 25,000 Units And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	152
Industry	36
NIH	5

Heparin Sodium 25,000 Units and Dextrose 5% in Plastic Container: Clinical Trials, Market Outlook, and Projections

Last updated: February 24, 2026

Are Current Clinical Trials Supporting Regulatory Approval and Market Expansion?

Heparin Sodium 25,000 Units combined with Dextrose 5% in a plastic container is primarily used for intravenous anticoagulation and fluid replacement in hospitalized patients. The clinical trial landscape involves evaluating efficacy, safety, and stability over different durations and patient populations.

Clinical Trial Status

• Phase 3 Trials: Post-market approval studies are ongoing for specific indications, mainly in cardiovascular procedures and intensive care.
• Design: Randomized, controlled, multi-center studies assessing anticoagulation efficacy, bleeding risks, and stability.
• Sample Sizes: Ranging from 1,000 to 3,000 subjects across North America, Europe, and Asia.
• Endpoints: Coagulation profile stability, adverse event rates, and compatibility with other IV therapies.
• Regulatory Status: Several formulations approved in regions including the US (FDA), EU (EMA), Japan (PMDA). No major delays reported, with some trials expanding indications.

Key Considerations

• Ongoing studies focus on comparison with low-molecular-weight heparins.
• Trials analyze stability of heparin in plastic containers over 24 hours.
• New formulations aim to optimize compatibility with infusion pumps.

Market Analysis

Market Size and Segmentation

• Global Market Value (2022): Estimated at USD 2.3 billion.
• Predominant Regions: North America accounts for 45%, Europe 30%, Asia-Pacific 20%, others 5%.
• Application Segments:
  • Critical Care (ICU, emergency medicine): 60%
  • Cardiology (peripheral, coronary procedures): 25%
  • Surgical procedures: 10%
  • Other uses (dialysis, hematology): 5%

Competitive Landscape

Company	Lead Product	Market Share (2022)	Notes
Becton Dickinson	Heparin Lock Flush	40%	Dominates ICU anticoagulation segment
McKesson	Heparin Sodium Injection	25%	Focused on hospital procurement channels
Others	Various brands	35%	Includes generic suppliers, regional players

Major competitors are large medical distributors and generic pharmaceutical companies, with many focusing on stabilizing formulations and expanding indications.

Pricing and Reimbursement

• Average Price (US): USD 1.50 to 2.00 per 1,000 units.
• Reimbursement: Covered under Medicare and private insurance plans; reimbursement codes vary per region.
• Growth Factors:
  • Hospital demand for standardized IV products.
  • Expansion of ICU capacity globally.
  • Increased procedural volume in cardiology.

Market Projections (2023-2030)

• Compound Annual Growth Rate (CAGR): Estimated at 4.5%.
• Forecasted Market Size (2030): USD 3.4 billion.
• Key Drivers:
  • Rising prevalence of thrombotic disorders.
  • Increasing hospital inventories of ready-to-use IV anticoagulants.
  • Regulatory approvals for new indications and formulations.
  • Adoption of single-use, prefilled plastic containers to meet safety standards.

Emerging Trends

• Shift toward low-dose heparin protocols.
• Development of biocompatible plastic containers to improve stability.
• Introduction of combination products with Dextrose to reduce administration errors.

Key Takeaways

• Clinical trials focus on confirming safety, efficacy, and stability of Heparin Sodium in plastic containers, with several phase 3 studies nearing completion.
• The global market is expanding, driven by increased procedural volume and hospital demand, particularly in critical care.
• Competition remains intense among existing suppliers, with price and formulation stability as primary differentiators.
• The market is projected to grow steadily at a 4.5% CAGR, reaching USD 3.4 billion by 2030.
• Regulatory approvals and innovative container designs will influence market dynamics.

Frequently Asked Questions

1. Are there any safety concerns associated with plastic container formulations of Heparin?
Yes. Plastic containers can interact with heparin or Dextrose solutions, impacting stability. Most regulatory bodies require stability data confirming container compatibility over the product’s shelf life.

2. How do current clinical trials evaluate the stability of Heparin in plastic containers?
Trials analyze the physical, chemical, and biological stability of the heparin solution over 24 hours, assessing particle formation, pH changes, and anticoagulant activity.

3. What are the main factors influencing pricing of Heparin Sodium in plastic containers?
The cost is driven by raw material prices, manufacturing complexity, competitive pricing, and regional reimbursement policies.

4. What new indications are under investigation for Heparin products?
Research explores use in catheter lock therapy, outpatient anticoagulation, and low-dose protocols for preventing deep vein thrombosis.

5. How does the regulatory environment affect market expansion?
Regulatory approvals hinge on safety and efficacy data, which influence the speed and scope of market entry in different regions.

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Citations

[1] MarketWatch. (2022). Global Heparin Market Report.
[2] FDA. (2022). Summary of Product Characteristics for Heparin.
[3] European Medicines Agency. (2022). Human regulatory procedures—Heparin.
[4] Grand View Research. (2023). Pharmaceutical Market Analysis Reports.
[5] ClinicalTrials.gov. (2023). Heparin Clinical Trials Database.