CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

All Clinical Trials for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

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 12,500 Units In Sodium Chloride 0.9%

Condition Name

Condition Name for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4

Condition MeSH

Condition MeSH for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6

Clinical Trial Locations for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Location	Trials
United States	44
China	16
Canada	14
Brazil	12
Germany	11

Trials by US State

Trials by US State for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
North Carolina	2

Clinical Trial Progress for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	15
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 12,500 Units in Sodium Chloride 0.9%: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin sodium, a widely used anticoagulant, is crucial in the prevention and treatment of thromboembolic disorders. This article will delve into the clinical trials, market analysis, and future projections for heparin sodium, particularly focusing on the 12,500 units in sodium chloride 0.9% formulation.

Clinical Trials and Efficacy

Low-Dose Prophylaxis

Numerous well-controlled clinical trials have demonstrated the efficacy of low-dose heparin prophylaxis in preventing postoperative thromboembolism. These trials show that heparin sodium, when administered subcutaneously, significantly reduces the risk of deep venous thrombosis (DVT) and pulmonary embolism[1].

Therapeutic Anticoagulant Effect

For therapeutic anticoagulation, heparin sodium is administered intravenously, either intermittently or via continuous infusion. Clinical trials have established that the dosage must be adjusted based on the patient’s coagulation test results, with the activated partial thromboplastin time (APTT) being a key indicator. The APTT should be 1.5 to 2 times the normal value to ensure adequate anticoagulation[1][4].

Specific Formulation: 12,500 Units in Sodium Chloride 0.9%

While specific clinical trials for the 12,500 units in sodium chloride 0.9% formulation may not be extensively detailed, this concentration is part of the broader spectrum of heparin sodium solutions used in clinical practice. It is often used for continuous intravenous infusion, where the initial dose and subsequent infusion rates are adjusted based on patient response and coagulation tests[1][4].

Pharmacokinetics and Pharmacodynamics

Peak Plasma Levels and Elimination

Peak plasma levels of heparin are achieved 2 to 4 hours following subcutaneous administration, with significant individual variations. The drug undergoes biphasic elimination, with a rapid alpha phase (half-life of 10 minutes) and a slower beta phase, especially after the age of 40. This biphasic elimination indicates uptake in various organs, including the liver and the reticuloendothelial system[1].

Protein Binding and Anticoagulant Activity

Heparin does not exhibit fibrinolytic activity, meaning it does not dissolve existing clots but rather prevents new clot formation. The anticoagulant effect of heparin is influenced by its protein binding, which can affect its half-life and efficacy[1].

Market Analysis

Global Market Size and Growth

The global heparin market was valued at USD 9.83 billion in 2023 and is projected to grow to USD 14.45 billion by 2032. This growth is driven by increasing demand for anticoagulant drugs, particularly in the treatment of conditions such as DVT, pulmonary embolism, and acute coronary syndromes[3].

Synthetic and Biosynthetic Heparin

There is a rising trend in the development of synthetic and biosynthetic heparin, driven by collaborations and investments in research and development. These initiatives aim to provide a stable and safe source of anticoagulant drugs, which is expected to further boost the market growth[3].

Current Market Challenges

The heparin market is currently facing challenges due to drug shortages. For instance, premixed bags of heparin sodium, including the 12,500 units in sodium chloride 0.9% formulation, are on back order due to increased demand and manufacturing delays. Companies like Baxter, Fresenius Kabi, and Pfizer are working to resolve these shortages, with estimated resupply dates ranging from late 2024 to early 2025[2].

Market Projections

Increasing Demand

The demand for heparin sodium is expected to continue rising due to its robust adoption in various medical applications, including prophylaxis and treatment of thromboembolic conditions. The growing awareness among patients about the effectiveness of heparin in preventing and treating these conditions is also anticipated to drive market growth[3].

New Formulations and Technologies

The development of new synthetic and biosynthetic heparin formulations is expected to introduce more stable and safe anticoagulant options. These advancements will likely contribute to the market's expansion, as they address the need for reliable anticoagulant drugs[3].

Applications and Uses

Deep Venous Thrombosis (DVT) and Pulmonary Embolism

Heparin sodium is widely used in the prevention and treatment of DVT and pulmonary embolism. Its efficacy in these conditions has been well-documented in clinical trials and is a key driver of its market demand[3].

Acute Coronary Syndromes and Percutaneous Coronary Intervention

Heparin is also used in the management of acute coronary syndromes and during percutaneous coronary intervention. Its anticoagulant properties help in preventing thrombus formation and reducing the risk of complications during these procedures[3].

Conclusion

Heparin sodium, including the 12,500 units in sodium chloride 0.9% formulation, remains a critical anticoagulant in clinical practice. The drug's efficacy in preventing and treating thromboembolic disorders is well-established through numerous clinical trials. Despite current market challenges such as drug shortages, the global heparin market is projected to grow significantly due to increasing demand and advancements in synthetic and biosynthetic formulations.

Key Takeaways

• Clinical Efficacy: Heparin sodium is effective in preventing postoperative thromboembolism and treating various thromboembolic conditions.
• Pharmacokinetics: The drug exhibits biphasic elimination and significant protein binding, affecting its anticoagulant activity.
• Market Growth: The global heparin market is projected to grow from USD 10.21 billion in 2024 to USD 14.45 billion by 2032.
• Current Challenges: Drug shortages due to increased demand and manufacturing delays are affecting the availability of heparin sodium premixed bags.
• Future Developments: Advancements in synthetic and biosynthetic heparin formulations are expected to drive market growth and provide safer anticoagulant options.

FAQs

What is the primary use of heparin sodium in clinical practice?

Heparin sodium is primarily used as an anticoagulant to prevent and treat thromboembolic disorders such as deep venous thrombosis (DVT) and pulmonary embolism.

How is heparin sodium administered?

Heparin sodium can be administered subcutaneously or intravenously, either intermittently or via continuous infusion, depending on the clinical indication and patient response.

What are the key factors affecting the pharmacokinetics of heparin sodium?

The pharmacokinetics of heparin sodium are influenced by its biphasic elimination, protein binding, and individual variations in patient response.

Why is there a current shortage of heparin sodium premixed bags?

The current shortage is due to increased demand and manufacturing delays experienced by companies such as Baxter, Fresenius Kabi, and Pfizer.

What are the future projections for the heparin market?

The global heparin market is expected to grow significantly, driven by increasing demand for anticoagulant drugs and advancements in synthetic and biosynthetic heparin formulations.

How does heparin sodium compare to other anticoagulants in terms of safety and efficacy?

Heparin sodium is a well-established anticoagulant with a proven safety and efficacy profile, although it does not dissolve existing clots and requires careful monitoring of coagulation tests to adjust dosages.

Sources

1. Heparin Sodium - accessdata.fda.gov
2. Drug Shortage Detail: Heparin Sodium Premixed Bags - ASHP
3. Heparin Market Size, Share & Global Forecast Report [2030] - Fortune Business Insights
4. Intravenous Solutions with Heparin Sodium Injection - accessdata.fda.gov

Last updated: 2025-01-02