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

All Clinical Trials for Heparin Sodium 12,500 Units In Dextrose 5%

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.

Clinical Trial Conditions for Heparin Sodium 12,500 Units In Dextrose 5%

Condition Name

Condition Name for Heparin Sodium 12,500 Units In Dextrose 5%
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for Heparin Sodium 12,500 Units In Dextrose 5%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 12,500 Units In Dextrose 5%

Trials by Country

Trials by Country for Heparin Sodium 12,500 Units In Dextrose 5%
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 Dextrose 5%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for Heparin Sodium 12,500 Units In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 12,500 Units In Dextrose 5%
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 Dextrose 5%
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 12,500 Units In Dextrose 5%

Sponsor Name

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

Sponsor Type

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

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

Introduction

Heparin Sodium in 5% Dextrose Injection is a widely used anticoagulant for various medical conditions, including the prevention and treatment of venous thrombosis, pulmonary embolism, and other thromboembolic complications. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Indications and Usage

Heparin Sodium in 5% Dextrose Injection is indicated for several critical medical conditions:

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism
• Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
• Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
• Prevention of clotting in arterial and cardiac surgery
• Prophylaxis and treatment of peripheral arterial embolism
• Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures[1][2][5].

Dosage and Administration

The dosing of Heparin Sodium in 5% Dextrose Injection varies based on the method of administration and the patient's condition:

• Intermittent Intravenous Injection: Initial dose of 10,000 Units, either undiluted or in 50 to 100 mL of 5% Dextrose Injection, followed by 5,000 to 10,000 Units every 4 to 6 hours.
• Continuous Intravenous Infusion: Initial dose of 5,000 Units by intravenous injection, followed by 20,000 to 40,000 Units every 24 hours in 1,000 mL of 5% Dextrose Injection[1][2][4].

Clinical Trials Update

While there are no recent groundbreaking clinical trials specifically focused on Heparin Sodium in 5% Dextrose Injection, ongoing research often involves comparing different anticoagulants and optimizing dosing regimens. For instance:

• Studies continue to evaluate the optimal dosing strategies to minimize the risk of bleeding and thrombocytopenia.
• Research on the use of heparin in specific patient populations, such as pediatric patients, is ongoing due to the lack of well-controlled studies in these groups[3].

Market Analysis

Current Market

Heparin Sodium in 5% Dextrose Injection is a staple in hospital settings and is widely used due to its efficacy in preventing and treating thromboembolic events. The market for anticoagulants is significant, driven by the high prevalence of cardiovascular diseases and the need for anticoagulation in various medical procedures.

Key Players

Major pharmaceutical companies such as Pfizer and other generic manufacturers are key players in the market. These companies ensure a steady supply of the drug and continuously update their formulations and dosing guidelines based on clinical evidence.

Market Trends

The anticoagulant market is evolving with the introduction of new oral anticoagulants (NOACs), but Heparin Sodium remains a preferred choice in many acute care settings due to its rapid onset of action and the ability to monitor its effects through laboratory tests.

Market Projections

Growth Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of conditions such as atrial fibrillation, deep vein thrombosis, and pulmonary embolism will continue to drive the demand for anticoagulants like Heparin Sodium.
• Advancements in Medical Procedures: The growth in the number of surgeries, dialysis procedures, and extracorporeal circulation will increase the need for anticoagulation.
• Aging Population: An aging population is more prone to thromboembolic events, further increasing the demand for Heparin Sodium.

Challenges

• Side Effects and Complications: Heparin-induced thrombocytopenia (HIT) and bleeding are significant concerns that may impact market growth.
• Competition from NOACs: The increasing adoption of NOACs could potentially reduce the market share of Heparin Sodium, although its use in acute settings is likely to remain robust.

Financial Projections

The global anticoagulant market, including Heparin Sodium in 5% Dextrose Injection, is expected to grow significantly over the next decade. Here are some key financial projections:

• Market Size: The anticoagulant market is projected to reach billions of dollars by 2030, with Heparin Sodium contributing a substantial portion.
• Growth Rate: The market is expected to grow at a compound annual growth rate (CAGR) of around 5-7% driven by the increasing demand for anticoagulants.

Key Takeaways

• Clinical Indications: Heparin Sodium in 5% Dextrose Injection is versatile and used for various thromboembolic conditions.
• Dosage and Administration: The drug requires careful dosing and monitoring to avoid complications.
• Market Analysis: The anticoagulant market is driven by the prevalence of cardiovascular diseases and advancements in medical procedures.
• Projections: The market is expected to grow, driven by an aging population and increasing medical procedures, despite competition from NOACs.

FAQs

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

Heparin Sodium in 5% Dextrose Injection is indicated for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, and other conditions[1][2][5].

What are the common dosing regimens for Heparin Sodium in 5% Dextrose Injection?

The dosing includes an initial dose of 10,000 Units followed by 5,000 to 10,000 Units every 4 to 6 hours for intermittent intravenous injection, and 20,000 to 40,000 Units every 24 hours for continuous intravenous infusion[1][2][4].

What are the potential side effects of Heparin Sodium in 5% Dextrose Injection?

Common side effects include hemorrhage, thrombocytopenia, heparin-induced thrombocytopenia (HIT), hypersensitivity reactions, hyperkalemia, and elevations of serum aminotransferases[2][3].

How does the market for Heparin Sodium in 5% Dextrose Injection compare to other anticoagulants?

While NOACs are gaining traction, Heparin Sodium remains a preferred choice in acute care settings due to its rapid onset and ability to be monitored through laboratory tests.

What are the growth drivers for the Heparin Sodium in 5% Dextrose Injection market?

The increasing prevalence of cardiovascular diseases, advancements in medical procedures, and an aging population are key drivers of market growth.

Sources

1. Drugs.com: Heparin and Dextrose: Package Insert / Prescribing Info.
2. Pfizer Medical Information: Heparin Sodium in 5% Dextrose Injection.
3. Pfizer Medical Information: Heparin Sodium in 5% Dextrose Injection 50 units/ml and 100 units/ml.
4. FDA: Heparin Sodium in 5% Dextrose Injection - accessdata.fda.gov.
5. DailyMed: Label: HEPARIN SODIUM AND DEXTROSE.