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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER


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All Clinical Trials for HEPARIN SODIUM 12,500 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention Trials
Healthy 4
Thrombosis 4
Covid19 4
Myocardial Infarction 4
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Condition MeSH

Condition MeSH for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention Trials
Thrombosis 13
Venous Thrombosis 7
Acute Kidney Injury 6
COVID-19 6
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Clinical Trial Locations for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 12,500 UNITS IN 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 12,500 UNITS IN 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 12,500 UNITS IN 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 12,500 UNITS IN 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor Trials
Ain Shams University 5
GlaxoSmithKline 4
Azidus Brasil 4
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Sponsor Type

Sponsor Type for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor Trials
Other 143
Industry 35
NIH 5
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HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Heparin Sodium 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 blood clots. This article will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Indications and Uses

Heparin sodium in 5% dextrose injection is indicated for anticoagulant therapy, including the prevention and treatment of deep vein thrombosis, pulmonary embolism, and other thromboembolic disorders. It is also used to maintain the patency of catheters and to prevent clot formation in arterial and venous catheters[3][5].

Clinical Trials and Efficacy

Clinical trials have consistently shown the efficacy of heparin sodium in preventing and treating thromboembolic events. These trials often focus on adjusting the dosage based on individual patient response, as measured by coagulation tests such as activated partial thromboplastin time (APTT) and whole blood clotting time[1][3].

Dosage and Administration

The dosage of heparin sodium in 5% dextrose injection is titrated to individual patient response. For intermittent intravenous injections, the initial dose is typically 10,000 units, followed by 5,000 to 10,000 units every 4 to 6 hours. For continuous intravenous infusion, the initial dose is 5,000 units, followed by 20,000 to 40,000 units every 24 hours[1][5].

Laboratory Monitoring

Regular laboratory monitoring is crucial to ensure the therapeutic anticoagulant effect and to minimize risks such as hemorrhage and thrombocytopenia. This includes periodic platelet counts, hematocrits, and tests for occult blood in stool[1].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions associated with heparin sodium include hemorrhage, thrombocytopenia, heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases[5].

Warnings and Precautions

Recent updates to the prescribing information highlight several critical warnings and precautions, including the risk of hemorrhage, HIT and HITT, hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases. These updates emphasize the need for careful monitoring and adjustment of dosage to mitigate these risks[1][5].

Market Analysis

Current Market Status

Heparin sodium in 5% dextrose injection is a staple in many healthcare settings due to its effectiveness in anticoagulant therapy. The market is dominated by several major pharmaceutical companies, with products available in various concentrations and packaging formats.

Market Trends

The demand for heparin sodium in 5% dextrose injection is driven by the increasing incidence of thromboembolic disorders, particularly in older populations and those with chronic conditions such as heart disease and cancer. Advances in medical technology and the expansion of healthcare services in emerging markets also contribute to the growing demand.

Competitive Landscape

The market for heparin sodium in 5% dextrose injection is competitive, with multiple manufacturers offering similar products. Key players focus on differentiating their products through innovative packaging, such as the use of latex-free, PVC-free, and DEHP-free containers, which enhance patient safety and convenience[3].

Market Projections

Future Demand

The global market for heparin sodium in 5% dextrose injection is expected to grow steadily over the next decade, driven by an aging population and an increase in the prevalence of conditions requiring anticoagulant therapy.

Technological Advancements

Future advancements in drug delivery systems and monitoring technologies are likely to enhance the safety and efficacy of heparin sodium in 5% dextrose injection. For instance, the development of more precise dosing systems and real-time monitoring tools could reduce the risk of adverse reactions.

Regulatory Environment

Regulatory updates and guidelines will continue to play a crucial role in shaping the market. Recent changes in contraindications, warnings, and precautions highlight the ongoing need for vigilance and adherence to best practices in prescribing and administering heparin sodium in 5% dextrose injection[1][5].

Key Takeaways

  • Clinical Indications: Heparin sodium in 5% dextrose injection is used for anticoagulant therapy, including prevention and treatment of deep vein thrombosis and pulmonary embolism.
  • Dosage and Monitoring: Dosage must be titrated based on individual patient response, with regular laboratory monitoring to ensure therapeutic effect and minimize risks.
  • Safety and Adverse Reactions: Common adverse reactions include hemorrhage, thrombocytopenia, HIT/HITT, hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases.
  • Market Analysis: The market is driven by increasing demand due to an aging population and the prevalence of thromboembolic disorders.
  • Future Projections: The market is expected to grow, driven by technological advancements and an expanding healthcare sector.

FAQs

What are the common indications for heparin sodium in 5% dextrose injection?

Heparin sodium in 5% dextrose injection is commonly used for anticoagulant therapy, including the prevention and treatment of deep vein thrombosis, pulmonary embolism, and to maintain the patency of catheters[3][5].

How is the dosage of heparin sodium in 5% dextrose injection adjusted?

The dosage is adjusted based on individual patient response, as measured by coagulation tests such as APTT and whole blood clotting time. Regular laboratory monitoring is essential[1].

What are the most common adverse reactions associated with heparin sodium in 5% dextrose injection?

Common adverse reactions include hemorrhage, thrombocytopenia, HIT/HITT, hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases[5].

What are the recent updates to the prescribing information for heparin sodium in 5% dextrose injection?

Recent updates include new contraindications, warnings, and precautions related to hemorrhage, HIT/HITT, hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases[1][5].

What are the market trends and projections for heparin sodium in 5% dextrose injection?

The market is expected to grow due to an aging population, increasing prevalence of thromboembolic disorders, and advancements in medical technology and healthcare services[3].

Sources

  1. Drugs.com: Heparin and Dextrose: Package Insert / Prescribing Info.
  2. FDA: Heparin Sodium in 5% Dextrose Injection.
  3. Health Canada: CIV HEPARIN SODIUM IN 5% DEXTROSE INJECTION.
  4. RxList: Heparin: Side Effects, Uses, Dosage, Interactions, Warnings.
  5. Pfizer Medical Information: Heparin Sodium in 5% Dextrose Injection.

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