CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

All Clinical Trials for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%

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 5,000 Units In Sodium Chloride 0.45%

Condition Name

Condition Name for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Intervention	Trials
Covid19	4
Myocardial Infarction	4
Healthy	4
Thrombosis	4

Condition MeSH

Condition MeSH for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%

Trials by Country

Trials by Country for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Location	Trials
United States	44
China	16
Canada	14
Brazil	12
Germany	11

Trials by US State

Trials by US State for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Georgia	2

Clinical Trial Progress for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	15
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 5,000 Units In Sodium Chloride 0.45%

Sponsor Name

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

Sponsor Type

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

Heparin Sodium 5,000 Units in Sodium Chloride 0.45%: Clinical Trials, Market Analysis, and Projections

Introduction to Heparin Sodium

Heparin sodium is a widely used anticoagulant medication, essential in preventing and treating thrombosis and embolism. It is available in various formulations, including injections in different concentrations, such as 5,000 units in sodium chloride 0.45%.

Clinical Uses of Heparin Sodium

Heparin sodium is indicated for several clinical applications, including:

Treatment of Venous Thromboembolism

Heparin is crucial in the treatment of deep venous thrombosis (DVT) and pulmonary embolism. It helps in preventing the formation of new clots and the extension of existing ones[3].

Complications of Pregnancy

Heparin is used to manage thromboembolic complications during pregnancy, where other anticoagulants like warfarin are contraindicated[2].

Cardioversion of Atrial Fibrillation/Flutter

Heparin is used to prevent thromboembolic events during cardioversion procedures for atrial fibrillation or flutter[2].

Peri-procedural Anticoagulation

It is used in various surgical procedures, including open-heart surgery, to maintain anticoagulation. For example, patients undergoing total body perfusion for open-heart surgery may receive an initial dose of 150-400 units of heparin sodium per kilogram of body weight[1].

Clinical Trials and Safety Considerations

Adverse Events and Contraindications

Heparin sodium has several potential adverse effects, including hemorrhage, heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases. These risks necessitate careful monitoring and dose adjustment[1].

Warnings and Precautions

Clinical trials and post-marketing surveillance have highlighted the importance of monitoring patients for signs of HIT and HITT, as these conditions can be life-threatening. Regular platelet count checks are recommended, especially during the first few days of heparin therapy[1].

Market Analysis of Heparin Sodium Injection

Global Market Size and Forecast

The global heparin sodium injection market is projected to grow significantly over the next few years. The market size is estimated to increase from $10.21 billion in 2024 to $14.45 billion by 2032, at a compound annual growth rate (CAGR) of 4.4% during the forecast period[3].

Market Segmentation

The market is segmented based on application, product concentration, and geographical regions. The treatment of venous thromboembolism segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period. Products with concentrations of 1,000 USP units/mL, 5,000 USP units/mL, and 10,000 USP units/mL are key segments[2][5].

Geographical Analysis

The market is geographically divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Asia-Pacific is expected to be a significant growth region due to increasing healthcare infrastructure and rising demand for anticoagulant medications[2][5].

Key Players and Competitive Landscape

Companies such as Shenzhen Hepalink, Nanjing Kingfriend, Pfizer, and Fresenius Kabi are major players in the heparin sodium injection market. These companies are focusing on expanding their product portfolios and business through strategic collaborations and investments in research and development[4][5].

Market Drivers and Trends

Increasing Demand for Anticoagulants

The growing awareness among patients about the effectiveness of heparin in treating thrombosis and embolism conditions is driving the demand for these medications. Additionally, the rising number of cardiovascular diseases and surgical procedures requiring anticoagulation is contributing to market growth[3].

R&D Initiatives

Pharmaceutical companies and research institutions are investing in developing new synthetic formulations and production methods for heparin. This includes the development of synthetic molecules like fondaparinux sodium, which are in advanced stages of development and expected to launch in the coming years[3].

Regulatory and Technological Trends

Advancements in manufacturing processes and the introduction of preservative-free formulations, such as Fresenius Kabi's Simplist Heparin prefilled syringes, are enhancing the safety and convenience of heparin sodium injections[4].

Projections and Future Outlook

Market Growth Projections

The global heparin sodium injection market is expected to continue its growth trajectory, driven by increasing demand and advancements in technology. The market is forecasted to expand significantly over the next decade, with the treatment of venous thromboembolism segment remaining a key driver[2][5].

Emerging Markets and Opportunities

Emerging markets, particularly in the Asia-Pacific region, offer significant opportunities for growth. Increasing healthcare spending and a growing patient population are expected to drive demand for heparin sodium injections in these regions[2][5].

Key Takeaways

• Clinical Uses: Heparin sodium is crucial in treating venous thromboembolism, complications of pregnancy, and peri-procedural anticoagulation.
• Safety Considerations: Monitoring for HIT, HITT, and other adverse effects is essential.
• Market Growth: The global heparin sodium injection market is projected to grow at a CAGR of 4.4% from 2024 to 2032.
• Market Segmentation: The market is segmented by application, product concentration, and geographical regions.
• Key Players: Companies like Shenzhen Hepalink, Nanjing Kingfriend, and Pfizer are major players.
• Future Outlook: Emerging markets and R&D initiatives are expected to drive future growth.

FAQs

What are the common clinical applications of heparin sodium?

Heparin sodium is commonly used in the treatment of venous thromboembolism, complications of pregnancy, cardioversion of atrial fibrillation/flutter, and peri-procedural anticoagulation.

What are the potential adverse effects of heparin sodium?

Potential adverse effects include hemorrhage, heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases.

What is the projected growth rate of the global heparin sodium injection market?

The global heparin sodium injection market is projected to grow at a CAGR of 4.4% from 2024 to 2032.

Which region is expected to dominate the global heparin sodium injection market?

The Asia-Pacific region is expected to be a significant growth region due to increasing healthcare infrastructure and rising demand for anticoagulant medications.

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

Key drivers include increasing demand for anticoagulants, R&D initiatives for synthetic formulations, and growing awareness among patients about the effectiveness of heparin.

Sources

1. Pfizer Medical Information: Heparin Sodium in 5% Dextrose Injection.
2. Market Research Intellect: Global Heparin Sodium Injection Market Size and Forecast.
3. Fortune Business Insights: Heparin Market Size, Share & Global Forecast Report [2030].
4. Fresenius Kabi: Fresenius Kabi Introduces Heparin Sodium Injection, USP Simplist.
5. Cognitive Market Research: Heparin Sodium Injection Market Report 2025 (Global Edition).