CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 10,000 UNITS IN 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.

Clinical Trial Conditions for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6

Clinical Trial Locations for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	44
China	16
Canada	14
Brazil	12
Germany	11

Trials by US State

Trials by US State for HEPARIN SODIUM 10,000 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 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

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Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	143
Industry	35
NIH	5

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Heparin Sodium 10,000 Units in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin Sodium, a widely used anticoagulant, has been a cornerstone in the prevention and treatment of various thromboembolic conditions for decades. This article delves into the current clinical trials, market analysis, and future projections for Heparin Sodium 10,000 Units in Dextrose 5% solution, particularly focusing on its use in intravenous administration.

Clinical Trials Update

Intranasal Heparin Trial (INHERIT)

One of the most promising and innovative clinical trials involving heparin is the INHERIT trial. This trial is assessing the efficacy and safety of intranasal heparin for the treatment of early COVID-19 infection and the prevention of its spread within household contacts. Although this trial does not specifically use the intravenous formulation of Heparin Sodium in 5% Dextrose, it highlights the versatility and potential of heparin in new therapeutic applications. The trial also explores the effect of heparin on "long COVID" symptoms, which could open new avenues for heparin's use beyond traditional anticoagulation[1].

Pharmacodynamic Profile Study

A phase I study is underway to determine the pharmacodynamic profile of intravenous heparin sodium of porcine origin. This study aims to evaluate the toxicity and pharmacokinetic profile of the drug in healthy male participants. The findings from this study will be crucial in understanding the safety and efficacy of heparin sodium in its current and potential future uses[4].

Market Analysis

Current Indications and Usage

Heparin Sodium in 5% Dextrose Injection is widely used for several indications, including the prophylaxis and treatment of venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, and the prevention of clotting in arterial and cardiac surgery. Its use in blood transfusions, extracorporeal circulation, and dialysis procedures further underscores its importance in clinical practice[5].

Market Demand

The demand for heparin sodium is consistent due to its critical role in managing and preventing thromboembolic events. The global anticoagulant market, which includes heparin sodium, is expected to grow due to increasing cases of cardiovascular diseases, the rising need for anticoagulant therapy in surgical procedures, and the expanding elderly population who are more prone to thromboembolic conditions.

Competitive Landscape

The market for heparin sodium is competitive, with several manufacturers producing the drug. However, the quality and source of heparin (porcine vs. bovine) can vary, affecting the market dynamics. The recent focus on biosimilar and generic versions of heparin sodium is also influencing the market, offering more affordable alternatives without compromising on efficacy and safety.

Projections and Future Outlook

Expanding Therapeutic Applications

The potential use of heparin in treating COVID-19, as seen in the INHERIT trial, suggests that heparin could play a broader role in infectious diseases beyond its traditional anticoagulant uses. This expansion could significantly impact the market demand and projections for heparin sodium.

Technological Advancements

Advancements in drug delivery systems and the development of new formulations (e.g., intranasal heparin) are expected to enhance the usability and efficacy of heparin sodium. These innovations could lead to increased adoption and market growth.

Regulatory Environment

Regulatory bodies such as the FDA and ANVISA (National Health Surveillance Agency) play a crucial role in approving new formulations and uses of heparin sodium. Compliance with these regulations and guidelines will be essential for manufacturers to ensure the continued availability and expansion of heparin sodium products.

Safety and Efficacy Considerations

Dosage and Administration

Heparin Sodium in 5% Dextrose Injection is administered intravenously, and its dosage must be carefully adjusted based on the patient’s coagulation test results. Continuous monitoring of coagulation parameters is recommended to ensure adequate anticoagulation without increasing the risk of bleeding[3].

Contraindications and Precautions

The drug is contraindicated in patients with severe thrombocytopenia, those with known hypersensitivity to heparin, and in certain conditions where anticoagulation is risky. Patients over 60 years may require lower doses, and periodic platelet counts and other coagulation tests are recommended during therapy[5].

Key Takeaways

• Clinical Trials: Ongoing trials like the INHERIT trial and pharmacodynamic profile studies are expanding our understanding of heparin's potential uses.
• Market Analysis: The demand for heparin sodium remains strong due to its critical role in anticoagulant therapy, with a competitive market driven by quality and source variations.
• Projections: Expanding therapeutic applications, technological advancements, and regulatory compliance are expected to drive market growth.
• Safety and Efficacy: Careful dosage adjustment and continuous monitoring are crucial to ensure the safe and effective use of heparin sodium.

FAQs

What is the primary use of Heparin Sodium in 5% Dextrose Injection?

Heparin Sodium in 5% Dextrose Injection is primarily used for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and other thromboembolic conditions.

Can Heparin Sodium be used in patients with COVID-19?

Current trials like the INHERIT trial are exploring the use of intranasal heparin for COVID-19 treatment and prevention, but this is not yet a standard indication for intravenous heparin sodium.

What are the contraindications for Heparin Sodium in 5% Dextrose Injection?

The drug is contraindicated in patients with severe thrombocytopenia, known hypersensitivity to heparin, and in certain conditions where anticoagulation is risky.

How is the dosage of Heparin Sodium in 5% Dextrose Injection adjusted?

The dosage is adjusted based on the patient’s coagulation test results, with continuous monitoring recommended to ensure adequate anticoagulation without increasing the risk of bleeding.

What are the potential future applications of Heparin Sodium?

Future applications may include the treatment of infectious diseases like COVID-19, as well as advancements in drug delivery systems and new formulations.

Sources

1. Intranasal Heparin Trial (INHERIT) - Murdoch Children's Research Institute.
2. CIV HEPARIN SODIUM IN 5% DEXTROSE INJECTION - Health Canada.
3. Heparin Sodium in 5% Dextrose Injection - FDA.
4. Study With Heparin Sodium in Intravenous Administration - ClinicalTrials.gov.
5. Heparin Sodium and Dextrose Injection - DailyMed.