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

All Clinical Trials for Heparin Sodium 10,000 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.
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 10,000 Units In Dextrose 5%

Condition Name

Condition Name for Heparin Sodium 10,000 Units In Dextrose 5%
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for Heparin Sodium 10,000 Units In Dextrose 5%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 10,000 Units In Dextrose 5%

Trials by Country

Trials by Country for Heparin Sodium 10,000 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 10,000 Units In Dextrose 5%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for Heparin Sodium 10,000 Units In Dextrose 5%

Clinical Trial Phase

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Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 10,000 Units In Dextrose 5%

Sponsor Name

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

Sponsor Type

Sponsor Type for Heparin Sodium 10,000 Units In Dextrose 5%
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 10,000 Units in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Heparin Sodium in 5% Dextrose Injection is a widely used anticoagulant derived from porcine intestinal mucosa. It is indicated for various clinical applications, including the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and other thromboembolic complications. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Indications and Usage

Heparin Sodium in 5% Dextrose Injection is versatile in its clinical applications. It is used for:

• 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[3][4].

Clinical Trials and Safety Profile

Efficacy and Safety Studies

Clinical trials have demonstrated the efficacy of heparin sodium in preventing and treating thromboembolic events. However, these studies also highlight the importance of careful dosing and monitoring to avoid complications such as bleeding and heparin-induced thrombocytopenia (HIT)[5].

Heparin-Induced Thrombocytopenia (HIT)

One of the significant safety concerns associated with heparin use is HIT, a condition characterized by a decrease in platelet count and an increased risk of thrombosis. Recent updates to the labeling include enhanced warnings about HIT, emphasizing the need for vigilance and appropriate monitoring[5].

Pediatric Use

There are limited data on the use of heparin sodium in pediatric patients. Current guidelines recommend caution and careful consideration due to the lack of adequate and well-controlled studies in this population[4].

Dosage and Administration

The dosage of heparin sodium in 5% dextrose injection varies based on the clinical indication and patient response. Here are some key dosing guidelines:

• Intermittent Intravenous Injection: Initial dose of 10,000 units, followed by 5,000 to 10,000 units every 4 to 6 hours.
• Continuous Intravenous Infusion: Initial dose of 5,000 units by IV injection, followed by a continuous infusion of 20,000 to 40,000 units per 24 hours.
• Intravascular via Total Body Perfusion: Initial dose of ≥150 units/kg, adjusted for longer procedures[4].

Market Analysis

Current Market Status

Heparin sodium in 5% dextrose injection is a well-established product in the anticoagulant market. It is manufactured and distributed by several pharmaceutical companies, including B. Braun Medical Inc. and Baxter Healthcare Corporation.

Market Trends

The demand for anticoagulants is increasing due to the growing prevalence of cardiovascular diseases and the need for effective thromboprophylaxis in various clinical settings. The market is also driven by advancements in medical procedures such as cardiac surgery and dialysis, where anticoagulation is crucial.

Competitive Landscape

The anticoagulant market is competitive, with several products available, including low molecular weight heparins (LMWHs) and direct oral anticoagulants (DOACs). However, heparin sodium remains a staple due to its broad range of indications and established safety profile.

Market Projections

Growth Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of conditions such as atrial fibrillation and deep vein thrombosis is expected to drive the demand for anticoagulants.
• Advancements in Medical Procedures: The growth in cardiac surgeries, dialysis procedures, and other medical interventions requiring anticoagulation will continue to support the market.
• Aging Population: The global aging population is more susceptible to thromboembolic events, further increasing the demand for heparin sodium.

Challenges

• Safety Concerns: The risk of HIT and other adverse effects may impact market growth if not adequately managed.
• Competition from Newer Anticoagulants: The introduction of newer anticoagulants with potentially better safety profiles could challenge the market share of heparin sodium.

Key Takeaways

• Clinical Indications: Heparin sodium in 5% dextrose injection is indicated for a wide range of thromboembolic conditions.
• Safety Profile: Careful dosing and monitoring are crucial to avoid complications like HIT.
• Market Trends: The market is driven by the increasing prevalence of cardiovascular diseases and advancements in medical procedures.
• Projections: The demand for heparin sodium is expected to grow, though it may face challenges from newer anticoagulants.

FAQs

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

Heparin Sodium in 5% Dextrose Injection is primarily indicated for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and other thromboembolic complications, as well as for preventing clotting in various medical procedures[3].

How is Heparin Sodium in 5% Dextrose Injection administered?

It is administered intravenously, either as an intermittent injection or as a continuous infusion. The dosage is adjusted based on the patient’s coagulation test results[4].

What are the key safety concerns associated with Heparin Sodium?

The main safety concerns include the risk of bleeding, heparin-induced thrombocytopenia (HIT), and hypersensitivity reactions to heparin or pork products[4][5].

Can Heparin Sodium in 5% Dextrose Injection be used in pediatric patients?

There are no adequate and well-controlled studies on the use of heparin sodium in pediatric patients, so its use in this population is not recommended without careful consideration and monitoring[4].

How does the market for Heparin Sodium in 5% Dextrose Injection look in the future?

The market is expected to grow driven by the increasing prevalence of cardiovascular diseases and advancements in medical procedures. However, it may face competition from newer anticoagulants with potentially better safety profiles.

Sources

1. Heparin Sodium in 5% Dextrose Injection - accessdata.fda.gov
2. Heparin Sodium in 5% Dextrose Injection - pfizermedicalinformation.com
3. Heparin Sodium and Dextrose Injection - dailymed.nlm.nih.gov
4. Heparin Sodium and Dextrose Injection - fda.report
5. Heparin Sodium in 5% Dextrose Injection - accessdata.fda.gov (Supplemental New Drug Application)

Last updated: 2025-01-09