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.
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 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
Covid19	4
Myocardial Infarction	4
Healthy	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	6
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	16
Canada	14
Brazil	12
Germany	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
Phase 4	27
Phase 3	15
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	47
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	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	143
Industry	35
NIH	5

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

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

Introduction

Heparin Sodium in 5% Dextrose Injection is a widely used anticoagulant derived from porcine intestinal mucosa. It is standardized for anticoagulant activity and is administered intravenously to prevent and treat various thrombotic conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Indications and Usage

Heparin Sodium in 5% Dextrose Injection is indicated for the prophylaxis and treatment of venous thrombosis and pulmonary embolism. It is also used in the management of atrial fibrillation with embolization, and for the treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)[4].

Clinical Trials and Monitoring

Clinical trials and real-world studies have consistently shown the efficacy of heparin in preventing and treating thrombotic events. The dosage of heparin is adjusted based on the patient’s coagulation test results, particularly the activated partial thromboplastin time (APTT) and whole blood clotting time. Regular monitoring, including periodic platelet counts, hematocrits, and tests for occult blood in stool, is recommended to ensure safety and efficacy[4].

Contraindications

The use of Heparin Sodium in 5% Dextrose Injection is contraindicated in patients with certain conditions, such as severe thrombocytopenia, active major bleeding, or a history of heparin-induced thrombocytopenia. It is also contraindicated in patients with known hypersensitivity to heparin or pork products[4].

Market Analysis

Current Market Size

The global heparin market was estimated at USD 7.56 billion in 2023. This market is dominated by North America, which accounted for 38.6% of the market share in 2023, driven by factors such as rising patient awareness, high disease burden, and advancements in healthcare infrastructure[2].

Growth Drivers

The heparin market is driven by several key factors:

• Increasing Prevalence of Chronic Diseases: Chronic diseases such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes are major drivers. For instance, cardiovascular diseases alone cause 17.9 million deaths annually[2].
• Growing Demand for Blood Components: The increasing need for whole blood and blood components transfusion, particularly in surgical and medical treatments, contributes to the market growth.
• Technological Advancements: Improvements in heparin production, the integration of digital technologies in heparin administration, and the development of biosynthetic heparin are significant growth drivers[5].

Regional Market

North America leads the heparin market due to a high disease burden, proactive government measures, and technological advancements. The presence of key players in this region further propels market growth[2].

Market Projections

Future Growth

The global heparin market is projected to grow at a compound annual growth rate (CAGR) of 2.7% from 2024 to 2030, reaching a market size of approximately USD 9.86 billion by 2024 and USD 12.92 billion by 2028[2][5].

Emerging Trends

Several trends are expected to shape the future of the heparin market:

• Biosynthetic Heparin: The development of biosynthetic heparin is expected to offer safer and more bioavailable alternatives.
• Digital Technologies: The integration of digital technologies in heparin administration will enhance patient safety and treatment efficacy.
• Biosimilars: The adoption of biosimilars will provide more affordable options for patients.
• Heparin Alternatives: Research into heparin alternatives and substitutes is ongoing, which may offer new treatment options in the future[5].

Safety and Efficacy

Clinical Studies

Clinical studies have shown that heparin is effective in preventing thrombotic events, but it requires careful monitoring to avoid adverse effects such as bleeding and thrombocytopenia. Lower doses of heparin may be indicated in certain patient populations to minimize risks[1].

Safety Profile

The safety profile of heparin includes potential side effects such as bleeding, thrombocytopenia, and hypersensitivity reactions. Regular monitoring and dose adjustments are crucial to mitigate these risks[4].

Conclusion

Heparin Sodium in 5% Dextrose Injection remains a critical anticoagulant in the management of various thrombotic conditions. The market for heparin is driven by the increasing prevalence of chronic diseases, technological advancements, and growing demand for blood components.

Key Takeaways

• Clinical Indications: Heparin is used for the prophylaxis and treatment of venous thrombosis and pulmonary embolism.
• Market Size: The global heparin market was estimated at USD 7.56 billion in 2023.
• Growth Drivers: Increasing prevalence of chronic diseases, growing demand for blood components, and technological advancements.
• Future Projections: The market is projected to grow at a CAGR of 2.7% from 2024 to 2030.
• Emerging Trends: Development of biosynthetic heparin, integration of digital technologies, and adoption of biosimilars.

FAQs

Q: What are the primary indications for Heparin Sodium in 5% Dextrose Injection?

A: The primary indications include the prophylaxis and treatment of venous thrombosis and pulmonary embolism, as well as the management of atrial fibrillation with embolization and acute and chronic consumptive coagulopathies[4].

Q: What are the key factors driving the growth of the heparin market?

A: The key factors include the increasing prevalence of chronic diseases, growing demand for whole blood and blood components, technological advancements, and improvements in healthcare infrastructure[2][5].

Q: What are the potential side effects of Heparin Sodium in 5% Dextrose Injection?

A: Potential side effects include bleeding, thrombocytopenia, and hypersensitivity reactions. Regular monitoring and dose adjustments are necessary to mitigate these risks[4].

Q: What are the emerging trends in the heparin market?

A: Emerging trends include the development of biosynthetic heparin, the integration of digital technologies in heparin administration, the adoption of biosimilars, and the exploration of heparin alternatives and substitutes[5].

Q: What is the projected market size of the heparin market by 2028?

A: The global heparin market is projected to reach approximately USD 12.92 billion by 2028[5].

Sources

1. Heparin Sodium in 5% Dextrose Injection - accessdata.fda.gov
2. Heparin Market Size, Share & Growth Analysis Report, 2030 - grandviewresearch.com
3. Heparin Sodium in 5% Dextrose Injection - accessdata.fda.gov
4. Heparin Sodium and Dextrose Injection - dailymed.nlm.nih.gov
5. Global Heparin Market Report 2024 - thebusinessresearchcompany.com