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

All Clinical Trials for Heparin Sodium 5,000 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.
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 5,000 Units In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Heparin Sodium 5,000 Units In Dextrose 5% In Plastic Container
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for Heparin Sodium 5,000 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 5,000 Units In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 5,000 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 5,000 Units In Dextrose 5% In Plastic Container
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Georgia	2

Clinical Trial Progress for Heparin Sodium 5,000 Units In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 5,000 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 5,000 Units In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 5,000 Units In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Heparin Sodium 5,000 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 5,000 Units In Dextrose 5% In Plastic Container
Sponsor	Trials
Other	143
Industry	35
NIH	5

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

Introduction

Heparin Sodium, a well-established anticoagulant, has been in use for over 80 years to treat various medical conditions, including heart attacks, strokes, and blood clots. Recently, its potential in treating COVID-19 has been explored, adding a new dimension to its clinical applications. Here, we will delve into the current clinical trials, market analysis, and future projections for Heparin Sodium 5,000 Units in Dextrose 5% solution.

Clinical Trials Update

Intranasal Heparin Trial (INHERIT)

One of the most significant ongoing 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 among household contacts. The trial also aims to evaluate the effect of heparin on "long COVID" symptoms that persist more than 12 weeks after the initial infection[1].

Pharmacodynamic Profile Studies

Another notable study is the phase I trial focused on the pharmacodynamic profile of intravenous heparin sodium in humans. This study, conducted by União Química, aims to build on existing pharmacodynamic data to generate a pharmacokinetic profile and evaluate the toxicity of the product in healthy male participants. This study follows the guidelines of the ANVISA (National Health Surveillance Agency) and is part of the development of heparin as a biological product[4].

Market Analysis

Current Market Status

Heparin Sodium in 5% Dextrose Injection is a widely used and established product in the market. It is marketed by several companies, including B. Braun Medical Inc., and has been available since 1998[5].

Market Demand

The demand for heparin products remains high due to their critical role in anticoagulant therapy. The COVID-19 pandemic has further highlighted the need for effective treatments and preventive measures, potentially increasing the demand for heparin-based solutions.

Competitive Landscape

The anticoagulant market is competitive, with various products available, including low molecular weight heparins and other anticoagulants. However, heparin's long history of use, safety profile, and cost-effectiveness make it a significant player in this market.

Safety and Efficacy

Safety Profile

Heparin Sodium in 5% Dextrose Injection has a well-documented safety profile. However, it is associated with certain risks such as thrombocytopenia, which can occur in up to 30% of patients receiving heparin. Regular monitoring of platelet counts is recommended during heparin therapy[2][3].

Efficacy

The efficacy of heparin in anticoagulant therapy is well established. Recent studies suggest that heparin may also bind to the COVID-19 virus, potentially reducing its ability to enter cells and multiply in the early stages of infection. This makes it a promising candidate for treating early COVID-19 infections and preventing community spread[1].

Market Projections

Future Trends

Given the ongoing clinical trials and the potential new applications of heparin in treating COVID-19, the market for Heparin Sodium 5,000 Units in Dextrose 5% is expected to grow. The need for effective, safe, and cost-efficient treatments will continue to drive demand.

Economic Impact

The economic impact of heparin-based treatments is significant. If intranasal heparin proves effective in reducing the spread of COVID-19, it could have a substantial economic benefit by reducing healthcare costs associated with treating severe cases and minimizing the economic disruption caused by the pandemic.

Regulatory Considerations

Approval and Compliance

Heparin Sodium in 5% Dextrose Injection is already approved and marketed in several countries. Any new applications or formulations, such as intranasal heparin, will need to comply with regulatory guidelines and undergo rigorous testing before approval.

Patient and Healthcare Provider Perspectives

Patient Benefits

For patients, the potential benefits of heparin-based treatments include reduced risk of severe COVID-19 symptoms and the prevention of long-term complications. The ease of administration, particularly with intranasal formulations, could also improve patient compliance.

Healthcare Provider Insights

Healthcare providers value heparin for its established safety and efficacy profile. The possibility of using heparin to treat COVID-19 adds a new tool to their arsenal, especially in settings where access to newer antiviral treatments may be limited.

Key Takeaways

• Clinical Trials: Ongoing trials like the INHERIT trial are exploring heparin's potential in treating COVID-19.
• Market Demand: The demand for heparin products is expected to remain high due to their critical role in anticoagulant therapy and potential new applications.
• Safety and Efficacy: Heparin has a well-documented safety profile, but it is associated with risks like thrombocytopenia. Its efficacy in anticoagulant therapy is well established.
• Market Projections: The market for Heparin Sodium 5,000 Units in Dextrose 5% is projected to grow, driven by new applications and the ongoing need for effective treatments.
• Regulatory Considerations: New formulations will need to comply with regulatory guidelines before approval.

FAQs

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

A: The primary use is for anticoagulant therapy, particularly for conditions such as heart attacks, strokes, and blood clots.

Q: What is the INHERIT trial, and what does it aim to achieve?

A: The INHERIT trial is assessing the efficacy and safety of intranasal heparin for treating early COVID-19 infection and preventing its spread among household contacts. It also evaluates the effect on "long COVID" symptoms.

Q: What are the potential risks associated with heparin therapy?

A: One of the significant risks is thrombocytopenia, which can occur in up to 30% of patients receiving heparin. Regular monitoring of platelet counts is recommended.

Q: How does heparin interact with the COVID-19 virus?

A: Recent studies suggest that heparin binds to the COVID-19 virus, potentially reducing its ability to enter cells and multiply in the early stages of infection.

Q: What is the expected economic impact if intranasal heparin proves effective against COVID-19?

A: If effective, intranasal heparin could significantly reduce healthcare costs associated with treating severe COVID-19 cases and minimize economic disruption caused by the pandemic.

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 - Veeva Systems.
5. HEPARIN SODIUM IN 5% DEXTROSE INJECTION, 25000UNIT/500ML - Health Canada.