CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

All Clinical Trials for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% 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 25,000 Units In Sodium Chloride 0.45% In Plastic Container

Condition Name

Condition Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Location	Trials
United States	44
China	16
Canada	14
Brazil	12
Germany	11

Trials by US State

Trials by US State for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% 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 In Sodium Chloride 0.45% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	15
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container

Sponsor Name

Sponsor Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Sponsor	Trials
Ain Shams University	5
Azidus Brasil	4
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 25,000 Units in Sodium Chloride 0.45%: Clinical Trials, Market Analysis, and Projections

Last updated: January 8, 2025

Introduction

Heparin sodium, a widely used anticoagulant, has been a cornerstone in medical treatment for over 80 years, particularly for conditions such as heart attacks, strokes, and blood clots. This article delves into the current clinical trials, market analysis, and future projections for heparin sodium, specifically the formulation of 25,000 units in sodium chloride 0.45% in plastic containers.

Clinical Trials Update

Intranasal Heparin Trial (INHERIT)

One of the most significant ongoing clinical trials involving heparin is the INHERIT trial. This study, conducted by Murdoch Children's, The University of Melbourne, Monash University, and the Northern Hospital, aims to assess the efficacy and safety of intranasal heparin for the treatment of early COVID-19 infection and the prevention of its spread among household contacts. The trial also investigates the effect of heparin on "long COVID" symptoms that persist more than 12 weeks after the initial infection.

Heparin's potential in this context is based on its ability to bind to the COVID-19 virus, thereby reducing its ability to enter cells and multiply. This approach is particularly important given the ongoing need for new strategies to reduce community spread, even with the availability of effective vaccines[1].

Intravenous Administration Studies

Another relevant study involves the intravenous administration of heparin sodium. A phase I study by União Química focuses on determining the pharmacodynamic profile of sodium heparin of porcine origin in humans. This study evaluates the toxicity and pharmacokinetic profile of the drug in healthy male participants, following the guidelines of the ANVISA (National Health Surveillance Agency)[4].

Market Analysis

Global Market Size and Forecast

The heparin sodium market has been growing steadily and is projected to continue this trend. As of 2024, the global heparin sodium market was valued at USD 5.76 billion and is expected to reach USD 9.72 billion by 2031, growing at a CAGR of 4.2% during the forecast period[5].

Regional Analysis

The market is segmented geographically into North America, Europe, Asia Pacific, and the rest of the world. North America is anticipated to hold the largest market share, driven by the presence of significant players and increased investments in research and development. The Asia Pacific region is also expected to see significant growth due to rising healthcare demands and economic development[5].

Market Drivers

Several factors are driving the growth of the heparin sodium market:

• Increasing Prevalence of Chronic Diseases: Conditions such as diabetes, cardiovascular diseases, and cancer are on the rise, leading to an increased demand for heparin sodium tubes for blood collection and diagnostic tests[2].
• Advancements in Medical Technologies: The adoption of point-of-care testing and other medical technologies is boosting the demand for heparin sodium tubes[2].
• Growing Awareness of Health Checkups: There is a growing awareness about the importance of regular health checkups, which further fuels the market growth[2].

Market Concentration and Trends

The heparin sodium tube market is highly concentrated, with a few major players controlling a significant share. The market is characterized by high barriers to entry, including regulatory approvals, manufacturing expertise, and distribution networks. Key trends include the rising demand for blood collection and diagnostic tests, advancements in medical technologies, and government initiatives to improve healthcare infrastructure[2].

Product Characteristics and Storage

Heparin Sodium in Sodium Chloride 0.45%

Heparin sodium in sodium chloride 0.45% is supplied in single-dose flexible plastic containers in various concentrations. For example, a common formulation includes 25,000 USP units/250 mL (100 USP units/mL). These solutions are stored at 20°C to 25°C (68°F to 77°F) and protected from freezing[3].

Safety and Efficacy

Safety Profile

Heparin sodium has a well-established safety profile, having been used for over half a century. It is known for its efficacy in preventing blood clots and is generally safe when used as directed. However, as with any anticoagulant, there are risks of bleeding and other adverse effects that need to be monitored[4].

Efficacy in Various Applications

Heparin sodium is effective in a range of medical applications, including the prevention of thrombosis, treatment of deep vein thrombosis, and management of acute coronary syndromes. Its potential use in treating early COVID-19 infection, as explored in the INHERIT trial, highlights its versatility and ongoing relevance in medical treatment[1].

Future Projections

Market Growth

The heparin sodium market is expected to continue growing, driven by increasing demand for anticoagulants in both clinical and research settings. The forecasted CAGR of 4.2% from 2024 to 2031 indicates a robust market with significant growth potential[5].

Emerging Applications

The ongoing research into new applications of heparin sodium, such as its use in COVID-19 treatment, suggests that the drug will remain a vital component of medical treatment for years to come. As medical technologies advance and healthcare demands evolve, heparin sodium is likely to adapt and remain a cornerstone in anticoagulant therapy.

Key Takeaways

• Clinical Trials: Ongoing trials like the INHERIT trial are exploring new applications of heparin sodium, including its use in treating COVID-19.
• Market Growth: The global heparin sodium market is projected to grow at a CAGR of 4.2% from 2024 to 2031.
• Regional Analysis: North America is expected to hold the largest market share, with significant growth anticipated in the Asia Pacific region.
• Market Drivers: Increasing prevalence of chronic diseases, advancements in medical technologies, and growing awareness of health checkups are key drivers.
• Safety and Efficacy: Heparin sodium has a well-established safety profile and is effective in various medical applications.

FAQs

What is the primary focus of the INHERIT trial involving heparin sodium?

The INHERIT trial focuses on assessing the efficacy and safety of intranasal heparin for the treatment of early COVID-19 infection and the prevention of its spread among household contacts, as well as its effect on "long COVID" symptoms.

What is the projected market size of the heparin sodium market by 2031?

The global heparin sodium market is projected to reach USD 9.72 billion by 2031, growing at a CAGR of 4.2% from 2024 to 2031.

What are the key drivers of the heparin sodium market growth?

Key drivers include the increasing prevalence of chronic diseases, advancements in medical technologies, and growing awareness of the importance of regular health checkups.

How is heparin sodium in sodium chloride 0.45% typically stored?

Heparin sodium in sodium chloride 0.45% is stored at 20°C to 25°C (68°F to 77°F) and protected from freezing.

What is the safety profile of heparin sodium?

Heparin sodium has a well-established safety profile, having been used for over half a century, but it carries risks such as bleeding when used as an anticoagulant.

Sources

1. Intranasal Heparin Trial (INHERIT) - Murdoch Children's Research Institute.
2. Heparin Sodium Tube in Emerging Markets: Analysis and ... - Data Insights Market.
3. Heparin Sodium in 0.45% Sodium Chloride Injection - Pfizer Medical Information.
4. Study With Heparin Sodium in Intravenous Administration - Veeva Systems.
5. In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast - Verified Market Research.