CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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.
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 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Myocardial Infarction	4
Healthy	4
Thrombosis	4
Covid19	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 20,000 UNITS IN 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 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
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 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 20,000 UNITS IN 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 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Ain Shams University	5
Azidus Brasil	4
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 20,000 Units in 5% Dextrose Injection: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin Sodium in 5% Dextrose Injection is a widely used anticoagulant therapy, particularly for preventing and treating thrombosis. Here, we will delve into the clinical trials, market analysis, and future projections for this specific formulation.

Clinical Trials and Efficacy

Anticoagulant Therapy

Numerous clinical trials have demonstrated the efficacy of heparin sodium in preventing and treating thromboembolic disorders. For instance, low-dose heparin prophylaxis has been shown to reduce the incidence of deep vein thrombosis and pulmonary embolism in surgical patients[4].

Dosage and Administration

Clinical trials have established guidelines for the administration of heparin sodium. For continuous intravenous infusion, the typical dosage ranges from 20,000 to 40,000 units per 24 hours in 1,000 mL of 0.9% Sodium Chloride Injection or other compatible solutions. The dosage is adjusted based on coagulation test results, with the aim of achieving an activated partial thromboplastin time (aPTT) of 1.5 to 2 times the normal value[1][3][4].

Pediatric and Geriatric Use

In pediatric patients, the initial dose is often 50 units/kg by intravenous infusion, followed by maintenance doses. For geriatric patients, lower doses may be necessary due to potential differences in drug metabolism and increased sensitivity[4].

Market Analysis

Current Market Status

Heparin Sodium in 5% Dextrose Injection is a staple in hospital settings and is widely used for anticoagulant therapy. The market is dominated by several key players, including Fresenius Kabi, Pfizer, and others. The demand for this formulation is consistent due to its critical role in patient care, particularly in surgical and intensive care units.

Market Trends

The anticoagulant market is evolving with advancements in drug delivery systems and the development of new anticoagulants. However, heparin sodium remains a preferred choice due to its well-established efficacy and safety profile. The trend towards using preservative-free formulations, especially in neonates and infants, is also a significant market driver[1][3].

Competitive Landscape

The market for heparin sodium in 5% dextrose injection is competitive, with multiple manufacturers offering similar products. Key differentiators include the concentration of heparin, the type of dextrose solution, and the packaging (e.g., plastic containers vs. glass vials). Companies like Fresenius Kabi and Pfizer have a strong presence in this market due to their extensive product lines and distribution networks[3][5].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the heparin sodium market:

• Increasing Surgical Procedures: The rise in surgical procedures, particularly in aging populations, will increase the demand for anticoagulant therapies.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to medical services in developing countries will also boost demand.
• New Indications: Research into new indications for heparin sodium, such as in the treatment of COVID-19-related thrombosis, could expand its market[4].

Market Size and Forecast

The global anticoagulant market, including heparin sodium formulations, is projected to grow significantly over the next few years. According to market research, the anticoagulant market is expected to reach billions of dollars by 2027, driven by the increasing prevalence of cardiovascular diseases and the growing need for anticoagulant therapies in various clinical settings.

Challenges and Opportunities

Regulatory Environment

Regulatory requirements and guidelines play a crucial role in the market for heparin sodium. Ensuring compliance with FDA and other regulatory bodies' standards is essential for manufacturers. For example, the use of preservative-free heparin in neonates and infants is strictly regulated[1][3].

Quality and Safety

Ensuring the quality and safety of heparin sodium products is a significant challenge. The contamination of heparin with oversulfated chondroitin sulfate in the past highlighted the need for stringent quality control measures. Manufacturers must adhere to strict manufacturing and testing protocols to maintain product integrity[3].

Innovations in Delivery Systems

Innovations in drug delivery systems, such as the use of plastic containers that are latex-free, PVC-free, and DEHP-free, offer opportunities for differentiation and market growth. These advancements can improve patient safety and convenience[5].

Key Takeaways

• Clinical Efficacy: Heparin sodium in 5% dextrose injection is a well-established anticoagulant with proven efficacy in clinical trials.
• Market Demand: The demand for this formulation is consistent and growing due to its critical role in patient care.
• Competitive Market: The market is competitive, with multiple manufacturers offering similar products.
• Growth Drivers: Increasing surgical procedures, advancements in healthcare, and new indications are expected to drive market growth.
• Regulatory Compliance: Ensuring compliance with regulatory standards is crucial for manufacturers.
• Innovations: Advancements in drug delivery systems offer opportunities for market differentiation and growth.

FAQs

What is the typical dosage for Heparin Sodium in 5% Dextrose Injection?

The typical dosage for continuous intravenous infusion ranges from 20,000 to 40,000 units per 24 hours in 1,000 mL of 0.9% Sodium Chloride Injection or other compatible solutions[1][3][4].

Why is preservative-free Heparin Sodium Injection recommended for neonates and infants?

Preservative-free Heparin Sodium Injection is recommended for neonates and infants due to the potential risks associated with preservatives in this vulnerable population[1][3].

How often should coagulation tests be performed during Heparin Sodium therapy?

Coagulation tests should be performed approximately every four hours in the early stages of treatment and at appropriate intervals thereafter to ensure adequate anticoagulation[1][3][4].

What are the key differentiators in the market for Heparin Sodium in 5% Dextrose Injection?

Key differentiators include the concentration of heparin, the type of dextrose solution, and the packaging (e.g., plastic containers vs. glass vials)[3][5].

What are the growth drivers for the Heparin Sodium market?

Growth drivers include increasing surgical procedures, advancements in healthcare, and potential new indications for heparin sodium[4].

Sources

1. Pfizer Medical Information: Heparin Sodium Injection CARPUJECT Dosage and Administration.
2. FDA: Heparin Sodium in 5% Dextrose Injection.
3. Fresenius Kabi: Heparin Sodium Injection, USP.
4. RxList: Heparin Sodium Injection Preservative Free.
5. Health Canada: Heparin Sodium in 5% Dextrose Injection.