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Last Updated: February 11, 2025

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


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All Clinical Trials for Heparin Sodium 10,000 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Intervention Trials
Healthy 4
Thrombosis 4
Covid19 4
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Condition MeSH

Condition MeSH for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Intervention Trials
Thrombosis 13
Venous Thrombosis 7
Acute Kidney Injury 6
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Clinical Trial Locations for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Location Trials
United States 44
China 16
Canada 14
Brazil 12
Germany 11
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Trials by US State

Trials by US State for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Location Trials
California 7
New York 5
Texas 4
Ohio 3
Maryland 2
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Clinical Trial Progress for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Clinical Trial Phase Trials
Phase 4 27
Phase 3 15
Phase 2/Phase 3 6
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Clinical Trial Status

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Withdrawn 10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

Sponsor Name

Sponsor Name for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Sponsor Trials
Ain Shams University 5
Azidus Brasil 4
GlaxoSmithKline 4
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Sponsor Type

Sponsor Type for Heparin Sodium 10,000 Units And Dextrose 5% In Plastic Container
Sponsor Trials
Other 143
Industry 35
NIH 5
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Heparin Sodium 10,000 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, standardized for anticoagulant activity. This article delves into the clinical trials, market analysis, and future projections for Heparin Sodium 10,000 Units in a 5% Dextrose solution, particularly when administered in plastic containers.

Clinical Trials and Safety Profile

Adverse Reactions and Monitoring

Clinical trials and post-market surveillance have highlighted several key adverse reactions associated with Heparin Sodium in 5% Dextrose Injection. These include major bleeding, fatal bleeding, and thrombocytopenia, with incidence rates of up to 7%, 2%, and 30%, respectively[4].

Heparin-Induced Thrombocytopenia (HIT)

One of the most significant concerns is Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT), which can occur even after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after heparin use should be evaluated for HIT and HITT[4].

Special Populations

In pregnant women, the safety of Heparin Sodium in 5% Dextrose Injection is not well established, as animal reproduction studies have not been conducted. It is also crucial to use caution in patients with diabetes or carbohydrate intolerance due to the dextrose content[4].

Laboratory Tests

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy to monitor for potential adverse effects[1].

Market Analysis

Market Size and Growth

The global heparin market is expected to experience strong growth, reaching $12.92 billion by 2028 with a compound annual growth rate (CAGR) of 7.0%. This growth is driven by increasing demand for low-molecular-weight heparin, the expansion of heparin use in cancer treatment, and the rising incidence of venous thromboembolism[2].

Key Trends

Several trends are shaping the heparin market:

  • Technological Advancements: Improvements in heparin production aim to create safer and more bioavailable products.
  • Digital Technologies: Integration of digital technologies in heparin administration is becoming more prevalent.
  • Biosimilars: The adoption of biosimilars offers cost-effective alternatives without compromising therapeutic efficacy.
  • Alternatives and Substitutes: The need for heparin alternatives is rising due to concerns over HIT and other side effects[2].

Application and End-User Analysis

Heparin Sodium is critical in various medical applications, including:

  • Surgery and Dialysis: Preventing and treating blood clots during these procedures.
  • Chronic Diseases: Managing conditions such as diabetes, which is projected to affect 783 million people by 2045[2][5].

Market Projections

Future Growth Drivers

The market for Heparin Sodium is expected to grow due to several factors:

  • Increasing Prevalence of Chronic Diseases: The rising incidence of diabetes, cardiovascular diseases, and other chronic conditions will drive the demand for anticoagulant therapy.
  • Innovations in Peptide Synthesis: Advances in peptide drug delivery systems, such as nano-carriers and conjugation techniques, will enhance the efficacy and safety of heparin products[5].

Regional Market Analysis

The global peptides and heparin market is segmented by region, with North America, Asia Pacific, Europe, and other regions contributing to the overall growth. The Asia Pacific region is expected to show significant growth due to an increasing aging population and the rising prevalence of cardiovascular diseases[5].

Technological and Regulatory Developments

Biosynthetic Heparin

The development of biosynthetic heparin is a significant trend, offering a potential alternative to traditional heparin derived from animal sources. This could address concerns over the safety and consistency of animal-derived heparin[2].

Quality Control Measures

Stringent quality control measures are in place to ensure the safety and efficacy of heparin products. This includes rigorous testing and monitoring to prevent contamination and ensure bioavailability[5].

Key Takeaways

  • Clinical Trials: Heparin Sodium in 5% Dextrose Injection has a well-documented safety profile, but it requires careful monitoring for adverse reactions such as HIT and bleeding.
  • Market Growth: The global heparin market is projected to grow significantly, driven by increasing demand for anticoagulant therapy and technological advancements.
  • Future Trends: The market will be influenced by the adoption of biosimilars, the development of biosynthetic heparin, and the integration of digital technologies in heparin administration.
  • Regional Analysis: The Asia Pacific region is expected to contribute substantially to the market growth due to demographic and epidemiological factors.

FAQs

What are the primary uses of Heparin Sodium in 5% Dextrose Injection?

Heparin Sodium in 5% Dextrose Injection is primarily used as an anticoagulant to prevent and treat blood clots during surgeries, dialysis, and in patients with venous thromboembolism.

What are the major adverse reactions associated with Heparin Sodium?

Major adverse reactions include major bleeding, fatal bleeding, thrombocytopenia, and Heparin-Induced Thrombocytopenia (HIT) and Thrombosis (HITT).

How is the global heparin market expected to grow?

The global heparin market is expected to grow to $12.92 billion by 2028 with a CAGR of 7.0%, driven by increasing demand for low-molecular-weight heparin and the expansion of heparin use in various medical treatments.

What are the key trends shaping the heparin market?

Key trends include technological advancements in heparin production, the adoption of biosimilars, integration of digital technologies, and the exploration of heparin alternatives and substitutes.

Why is there a growing need for heparin alternatives?

The growing need for heparin alternatives is driven by concerns over heparin-induced thrombocytopenia (HIT) and other serious side effects associated with traditional heparin use.

Sources

  1. Heparin Sodium in 5% Dextrose Injection - FDA Label[1]
  2. Global Heparin Market Report 2024 - The Business Research Company[2]
  3. Heparin Sodium in 5% Dextrose Injection - FDA Label[3]
  4. CIV Heparin Sodium in 5% Dextrose Injection - Health Canada[4]
  5. Peptides and Heparin Market Analysis - Global Market Estimates[5]

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