CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM

All Clinical Trials for HEPARIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for HEPARIN SODIUM

Condition Name

Condition Name for HEPARIN SODIUM
Intervention	Trials
Covid19	4
Myocardial Infarction	4
Healthy	4
Thrombosis	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for HEPARIN SODIUM

Trials by Country

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−

Trials by Country for HEPARIN SODIUM
Location	Trials
United States	44
China	16
Canada	14
Brazil	12
Germany	11

Trials by US State

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−

Trials by US State for HEPARIN SODIUM
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for HEPARIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	15
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM

Sponsor Name

Sponsor Name for HEPARIN SODIUM
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Heparin Sodium

Heparin sodium, a widely used anticoagulant, has been a cornerstone in the prevention and treatment of blood clots for decades. Its applications span various medical conditions, including cardiovascular diseases, deep vein thrombosis, and pulmonary embolism. Here, we will delve into the current clinical trials, market analysis, and future projections for heparin sodium.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently concluded to evaluate the efficacy and safety of heparin sodium in different clinical settings.

Interstitial Cystitis Trial

A Phase 2 trial is ongoing to assess the efficacy and safety of a combination product (VNX001) that includes heparin sodium and lidocaine hydrochloride for reducing bladder pain in patients with interstitial cystitis (IC) or bladder pain syndrome (BPS). This randomized, double-blind, placebo-controlled study aims to compare the combination product with its individual components and a placebo[1].

Severe Sepsis Trial

Another significant trial is evaluating the efficacy and safety of unfractionated heparin (UFH) in patients with severe sepsis and suspected disseminated intravascular coagulation (DIC). This Phase 3 study aims to estimate the impact of UFH on ICU mortality, 28-day mortality, and clinical scores such as the Japanese Association for Acute Medicine (JAAM) score and SOFA score[4].

Objectives and Methodologies

These trials are designed to address specific clinical questions:

• Efficacy: To determine the effectiveness of heparin sodium in reducing symptoms or improving outcomes in various conditions.
• Safety: To evaluate the side effects and safety profile of heparin sodium, especially when used in combination with other drugs or in different patient populations.
• Comparative Analysis: To compare the outcomes of heparin sodium with other anticoagulants or placebo.

Market Analysis

Current Market Size and Growth

The global heparin market has been growing steadily due to several factors:

• Market Size: As of 2022, the heparin market was valued at approximately USD 7.42 billion and is expected to reach USD 10.93 billion by 2030, growing at a CAGR of 5.05% during the forecast period[3].
• Regional Dominance: North America holds the largest share of the heparin market, driven by high healthcare expenditure, advanced infrastructure, and a growing geriatric population. The Asia Pacific region is expected to be the fastest-growing market during the forecast period[5].

Drivers of Market Growth

Several factors are driving the growth of the heparin market:

• Increasing Prevalence of Chronic Diseases: The rising incidence of cardiovascular diseases, pulmonary embolism, and venous thromboembolism is a significant driver. For instance, in the U.S., cardiovascular diseases account for around 2,300 deaths per day[2].
• Improving Healthcare Infrastructure: Higher healthcare expenditure and improving healthcare infrastructure, especially in North America, are contributing to market growth[2].
• Aging Population: The global geriatric population is increasing, and this demographic is more prone to conditions requiring anticoagulant therapy. By 2050, the global population aged 65 and above is expected to reach about 1.5 billion[5].

Route of Administration and Application Type

• Parenteral Administration: This remains the preferred route due to its ease of administration, reduced risk of systemic infection, and improved quality of life. It is particularly favored in hospital settings and home care[2].
• Application Type: Heparin is used in various applications, including cardiovascular surgeries, dialysis, and the prevention of deep vein thrombosis. The increasing number of medical surgeries and accidents also contributes to the demand for heparin[3].

Market Projections

Future Growth and Trends

The heparin market is expected to continue its growth trajectory driven by several factors:

• Technological Advancements: Innovations in drug delivery systems and the development of biosimilar low molecular weight heparins (LMWH) are expected to boost market growth[3].
• Emerging Markets: The rise of emerging economies and increasing investment in healthcare infrastructure will provide new opportunities for market expansion[5].
• Research and Development: Ongoing research and development activities, including clinical trials, will further enhance the therapeutic potential of heparin and drive market growth[3].

Regional Outlook

• North America: Expected to remain the largest market due to its advanced healthcare infrastructure, high patient awareness, and significant healthcare expenditure[5].
• Asia Pacific: Anticipated to be the fastest-growing region, driven by economic development, improving healthcare infrastructure, and a large patient population[5].

Key Players

The global heparin market is fragmented with several key players:

• Opocrin SpA
• Baxter International Inc.
• Aspen Pharmacare Holdings Limited
• B Braun Melsungen AG
• Pfizer Inc.
• FRESENIUS KABI
• GLAND PHARMA
• HIKMA PHARMACEUTICALS
• Techdow USA
• Viatris Inc.
• Novartis AG
• Smiths Medical[5].

Challenges and Restraints

Despite the growth prospects, the heparin market faces some challenges:

• High Cost: The high cost associated with heparin, especially in some regions, can be a barrier to access[3].
• Safety Concerns: While heparin is generally safe, there are risks of bleeding and other side effects, which need to be carefully managed[4].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy and safety of heparin sodium in various clinical settings, including interstitial cystitis and severe sepsis.
• Market Growth: The global heparin market is expected to grow significantly, driven by increasing chronic diseases, improving healthcare infrastructure, and an aging population.
• Regional Dominance: North America currently holds the largest market share, with the Asia Pacific region expected to be the fastest-growing.
• Key Players: Several major pharmaceutical companies are active in the heparin market, contributing to its growth through innovation and expansion.

FAQs

What is the current size of the global heparin market?

The global heparin market was valued at approximately USD 7.42 billion in 2022 and is expected to reach USD 10.93 billion by 2030[3].

Which region dominates the heparin market?

North America currently holds the largest share of the heparin market, driven by advanced healthcare infrastructure and high healthcare expenditure[5].

What are the key drivers of the heparin market growth?

The key drivers include the increasing prevalence of chronic diseases, improving healthcare infrastructure, and an aging population[2][5].

Who are the major players in the global heparin market?

Major players include Opocrin SpA, Baxter International Inc., Aspen Pharmacare Holdings Limited, B Braun Melsungen AG, and Pfizer Inc.[5].

What are the challenges facing the heparin market?

High costs and safety concerns, such as the risk of bleeding, are significant challenges facing the heparin market[3][4].

Sources

1. UCSD Interstitial Cystitis Trial: "VNX001 Compared to Its Individual Components for the Reduction of Bladder Pain in Patients with IC/BPS" - ClinicalTrials.gov.
2. Heparin Market: "Heparin Market - IndustryARC".
3. Global Heparin Market: "Global Heparin Market – Industry Trends and Forecast to 2030" - Data Bridge Market Research.
4. Efficacy and Safety of Unfractionated Heparin: "Efficacy and Safety of Unfractionated Heparin on Severe Sepsis with Suspected Disseminated Intravascular Coagulation" - CenterWatch.
5. Heparin Market Report: "Heparin Market Report | Industry Analysis, Size & Forecast Overview" - Mordor Intelligence.