CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%

All Clinical Trials for Heparin Sodium 20,000 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.

Clinical Trial Conditions for Heparin Sodium 20,000 Units In Dextrose 5%

Condition Name

Condition Name for Heparin Sodium 20,000 Units In Dextrose 5%
Intervention	Trials
Healthy	4
Thrombosis	4
Covid19	4
Myocardial Infarction	4

Condition MeSH

Condition MeSH for Heparin Sodium 20,000 Units In Dextrose 5%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 20,000 Units In Dextrose 5%

Trials by Country

Trials by Country for Heparin Sodium 20,000 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 20,000 Units In Dextrose 5%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Georgia	2

Clinical Trial Progress for Heparin Sodium 20,000 Units In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 20,000 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 20,000 Units In Dextrose 5%
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 20,000 Units In Dextrose 5%

Sponsor Name

Sponsor Name for Heparin Sodium 20,000 Units In Dextrose 5%
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 20,000 Units In Dextrose 5%
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 20,000 Units in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin Sodium in 5% Dextrose Injection is a widely used anticoagulant, essential in various medical procedures to prevent and treat thrombosis. This article will delve into the 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, including:

• Atrial Fibrillation with Embolization: To prevent clot formation and embolization in patients with atrial fibrillation[4].
• Acute and Chronic Consumption Coagulopathies: For the diagnosis and treatment of conditions like disseminated intravascular coagulation (DIC)[4].
• Prevention of Clotting in Surgery: Used in arterial and heart surgery to prevent clot formation[4].
• Prophylaxis and Treatment of Peripheral Arterial Embolism: To prevent and treat embolic events in peripheral arteries[4].
• Anticoagulant in Extracorporeal Circulation and Dialysis: Essential in maintaining anticoagulation during extracorporeal procedures and dialysis[4].

Clinical Trials and Efficacy

Clinical trials have consistently shown the efficacy of heparin sodium in preventing thrombosis and managing coagulopathies. Here are some key points:

• Anticoagulant Activity: Heparin sodium has been proven to effectively prolong the activated partial thromboplastin time (APTT), which is a critical marker for anticoagulation[1][3][4].
• Safety Profile: While heparin is generally safe, it can cause significant side effects such as hemorrhage, heparin-induced thrombocytopenia (HIT), and hypersensitivity reactions. Clinical trials emphasize the need for careful monitoring and dose adjustment based on coagulation tests[3][4].
• Comparative Studies: Studies comparing heparin with other anticoagulants have shown that heparin remains a gold standard for many indications due to its rapid onset of action and ease of administration[4].

Market Analysis

Current Market

The market for heparin sodium in 5% dextrose injection is substantial, driven by its widespread use in hospitals and clinical settings.

• Demand: The demand is high due to the necessity of anticoagulation in various medical procedures, including surgeries, dialysis, and the management of thrombotic disorders[4].
• Competitors: The market is competitive with multiple manufacturers offering heparin sodium products. However, the brand loyalty and trust in established manufacturers like Pfizer and others play a significant role in market share[3].

Market Trends

• Increasing Use in Emerging Markets: There is a growing demand for heparin sodium in emerging markets where healthcare infrastructure is expanding and the need for anticoagulants is increasing[4].
• Advancements in Formulations: There is ongoing research into improving the formulations of heparin sodium to enhance its safety profile and efficacy. For example, low molecular weight heparins are being developed to reduce the risk of HIT and other complications[4].

Projections

Future Demand

The demand for heparin sodium in 5% dextrose injection is expected to continue growing due to several factors:

• Aging Population: An aging population increases the incidence of conditions requiring anticoagulation, such as atrial fibrillation and deep vein thrombosis[4].
• Advancements in Medical Procedures: The advancement in surgical and dialysis procedures will continue to drive the demand for reliable anticoagulants like heparin sodium[4].

Market Growth

The market for heparin sodium is projected to grow at a steady rate, driven by the increasing need for anticoagulation therapies.

• Global Expansion: The global market is expected to expand as healthcare access improves in developing countries, leading to increased usage of heparin sodium in these regions[4].

Safety and Precautions

Contraindications

Heparin sodium is contraindicated in patients with:

• Severe Thrombocytopenia: Due to the risk of heparin-induced thrombocytopenia (HIT)[4].
• Active Bleeding: Heparin should not be used in patients with active bleeding or a high risk of bleeding[4].

Warnings and Precautions

• Hemorrhage: One of the most significant risks associated with heparin therapy is hemorrhage. Close monitoring of coagulation tests is essential[3][4].
• Heparin-Induced Thrombocytopenia (HIT): A serious complication that can occur, necessitating regular platelet count monitoring[3][4].

Dosage and Administration

Recommended Dosages

The dosage of heparin sodium varies based on the clinical indication and patient's response:

• Initial Dose: Typically 10,000 units administered intravenously, either undiluted or in 50-100 mL of 5% dextrose injection[3][4].
• Continuous Infusion: 20,000 to 40,000 units per 24 hours in 1,000 mL of 5% dextrose injection[4].

Monitoring

• Coagulation Tests: Regular coagulation tests, such as APTT, are crucial to adjust the dosage and ensure therapeutic anticoagulation levels[1][3][4].

Key Takeaways

• Heparin Sodium in 5% Dextrose Injection is a critical anticoagulant used in various medical conditions.
• Clinical Trials have established its efficacy and safety profile, though careful monitoring is necessary.
• Market Demand is expected to grow due to an aging population and advancements in medical procedures.
• Safety Precautions include monitoring for hemorrhage, HIT, and other complications.

FAQs

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

Heparin Sodium in 5% Dextrose Injection is indicated for conditions such as atrial fibrillation with embolization, acute and chronic consumption coagulopathies, prevention of clotting in surgery, and as an anticoagulant in extracorporeal circulation and dialysis procedures[4].

What are the common side effects of Heparin Sodium?

Common side effects include hemorrhage, heparin-induced thrombocytopenia (HIT), hypersensitivity reactions, and hyperkalemia[3][4].

How is Heparin Sodium administered?

Heparin Sodium can be administered by intermittent intravenous injection or continuous intravenous infusion. The dosage should be adjusted based on coagulation test results[3][4].

Can Heparin Sodium be used in pregnant women?

Heparin sodium should be used in pregnant women only if clearly needed, as its effects on the fetus are not well understood[4].

What are the contraindications for Heparin Sodium?

Heparin sodium is contraindicated in patients with severe thrombocytopenia, active bleeding, or a high risk of bleeding[4].

Sources

1. Heparin Sodium in 5% Dextrose Injection - FDA Label[1].
2. Health Products - Canada.ca[2].
3. Pfizer Medical Information - Heparin Sodium in 5% Dextrose Injection[3].
4. Heparin Sodium in 20,000 Units/500 mL in Dextrose 5% Injection - Health Canada[4].
5. DailyMed - Heparin Sodium 20,000 USP Units Added to 5% Dextrose 500 mL Bag[5].