CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM IN PLASTIC CONTAINER

All Clinical Trials for Heparin Sodium 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 In Plastic Container

Condition Name

Condition Name for Heparin Sodium In Plastic Container
Intervention	Trials
Covid19	4
Myocardial Infarction	4
Healthy	4
Thrombosis	4

Condition MeSH

Condition MeSH for Heparin Sodium In Plastic Container
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 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 In Plastic Container
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Georgia	2

Clinical Trial Progress for Heparin Sodium In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 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 In Plastic Container
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium In Plastic Container

Sponsor Name

Sponsor Name for Heparin Sodium In Plastic Container
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium In Plastic Container
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin sodium is a widely used anticoagulant, essential in the prevention and treatment of various thromboembolic conditions. This article delves into the clinical aspects, market analysis, and future projections of heparin sodium, particularly when stored in plastic containers.

Clinical Stability of Heparin Sodium in Plastic Containers

Studies have shown that heparin sodium can be stored in polypropylene syringes for up to three weeks without refrigeration, maintaining its efficacy. A study published on PubMed found that when heparin sodium was diluted to 500 units/ml and stored in 50-ml polypropylene syringes, there was only an 8% decrease in heparin activity over three weeks at both room temperature and 0-4°C[1].

Storage Considerations

It is crucial to avoid storing diluted heparin sodium in glass containers due to the absorption of heparin to glass surfaces, which significantly reduces its activity within two hours[1].

Market Analysis of Heparin Sodium

Market Size and Forecast

The global heparin sodium market is projected to experience significant growth. By 2027, the market size is estimated to reach $2.4 billion, growing at a CAGR of 3.6% from 2022 to 2027[2]. Another forecast indicates that the market will reach $9.72 billion by 2031, growing at a CAGR of 4.2% from 2024 to 2031[3].

Market Segmentation

The heparin sodium market can be segmented by administration, product type, and geographical region.

By Administration

The injectable route is the fastest-growing segment, driven by the higher efficacy and quicker absorption of low molecular weight heparins (LMWH) when administered subcutaneously or intravenously[2].

By Product Type

The market includes high molecular weight heparins, LMWH, heparinoids, and unfractionated heparins. LMWHs are particularly popular due to their ease of administration and reduced risk of complications[2].

By Geographical Region

North America currently holds the largest market share, but the Asia-Pacific region is expected to dominate the market in the coming years due to increasing population, improving healthcare infrastructure, and significant investments in research and development[2].

Drivers of the Heparin Sodium Market

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases such as deep vein thrombosis (DVT), peripheral artery disease (PAD), and atrial fibrillation is a major driver of the heparin sodium market. These conditions necessitate the use of anticoagulants to prevent thromboembolic events[2][3].

Technological Advancements

Advancements in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations. Innovations such as needle-free injectors are also contributing to market growth[2][3].

Growing Healthcare Expenditure

Increasing healthcare spending, particularly in emerging economies, is making modern medical therapies like heparin sodium more accessible. This trend is expected to support market expansion in these regions[3].

Regulatory Support

Strict regulatory guidelines and approvals for new formulations and indications are ensuring the safety and quality of heparin sodium products, further driving market growth[3].

Challenges Facing the Heparin Sodium Market

Side Effects

One of the major challenges is the side effects associated with heparin use, such as excessive bleeding. These adverse effects can hamper market growth[2].

Supply Chain Issues

Disruptions in the supply chain can also impact the availability and distribution of heparin sodium, posing a challenge to market expansion[2].

Clinical Indications and Usage

Heparin sodium is indicated for a variety of clinical uses, including:

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism
• Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
• Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
• Prevention of clotting in arterial and cardiac surgery
• Prophylaxis and treatment of peripheral arterial embolism
• Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures[4].

Patient Counseling and Administration

Preparation for Administration

It is essential to confirm the correct formulation and strength of heparin sodium before administration. The product should be inspected visually for particulate matter and discoloration, and it should not be administered unless the solution is clear and the container is undamaged[4].

Administration

Heparin sodium should be administered by intravenous infusion and should not be admixed with other drugs or infused under pressure[4].

Key Takeaways

• Heparin sodium can be stored in polypropylene syringes for up to three weeks without refrigeration.
• The global heparin sodium market is projected to grow significantly, driven by increasing prevalence of cardiovascular diseases and technological advancements.
• The market is segmented by administration, product type, and geographical region, with the Asia-Pacific region expected to dominate in the future.
• Side effects and supply chain issues are major challenges facing the market.
• Heparin sodium has multiple clinical indications, and proper administration and patient counseling are crucial.

FAQs

What is the recommended storage method for diluted heparin sodium?

Diluted heparin sodium should be stored in polypropylene syringes rather than glass containers to avoid absorption of heparin to glass surfaces[1].

What are the primary drivers of the heparin sodium market?

The primary drivers include the increasing prevalence of cardiovascular diseases, technological advancements in drug delivery, growing healthcare expenditure, and regulatory support[2][3].

What are the common side effects of heparin sodium?

Common side effects include excessive bleeding, which can hamper market growth[2].

What are the clinical indications for heparin sodium?

Heparin sodium is indicated for prophylaxis and treatment of various thromboembolic conditions, prevention of clotting in surgeries, and anticoagulant use in medical procedures[4].

How should heparin sodium be administered?

Heparin sodium should be administered by intravenous infusion, ensuring the correct formulation and strength, and should not be admixed with other drugs or infused under pressure[4].

Sources

1. Stability of diluted heparin sodium stored in plastic syringes - PubMed
2. Heparin Sodium Market - Forecast(2022 - 2027) - IndustryARC
3. In-Depth Industry Outlook: Heparin Sodium Market Size, Forecast - Verified Market Research
4. Label: HEPARIN SODIUM injection, solution - DailyMed
5. Heparin Market Size to Hit USD 9.72 billion by 2033 - Precedence Research