CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

All Clinical Trials for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%

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.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	McMaster University	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.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.

Clinical Trial Conditions for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%

Condition Name

Condition Name for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
Intervention	Trials
Thrombosis	4
Covid19	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	6
COVID-19	6

Clinical Trial Locations for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%

Trials by Country

Trials by Country for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
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 Sodium Chloride 0.45%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
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 Sodium Chloride 0.45%
Clinical Trial Phase	Trials
Completed	47
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%

Sponsor Name

Sponsor Name for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 10,000 Units In Sodium Chloride 0.45%
Sponsor	Trials
Other	143
Industry	35
NIH	5

Heparin Sodium 10,000 Units in Sodium Chloride 0.45%: Clinical Trials, Market Analysis, and Projections

Introduction to Heparin Sodium

Heparin sodium is a widely used anticoagulant derived from porcine or bovine sources. It has been a cornerstone in the prevention and treatment of thromboembolic disorders for over half a century. This article will delve into the current clinical trials, market analysis, and future projections for heparin sodium, particularly focusing on the formulation of 10,000 units in sodium chloride 0.45%.

Clinical Trials Update

Phase I Study on Pharmacodynamic Profile

A recent Phase I study, conducted by União Química, aims to determine the pharmacodynamic profile of heparin sodium of porcine origin when administered intravenously in humans. This study is crucial as it is the first human biological product developed by União Química, despite heparin being well-established globally. The study follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide and involves healthy male participants to evaluate the product's toxicity and pharmacokinetic profile[1][4].

Objectives and Methodology

The primary objective is to generate pharmacodynamic data and build a pharmacokinetic profile due to the limitations in directly measuring heparin in biological samples. The study uses a control heparin to evaluate the results of the test product without the need to demonstrate bioequivalence among the evaluated products. This approach ensures that the new product meets the safety and efficacy standards expected from heparin sodium.

Market Analysis

Global Heparin Market Size and Forecast

The global heparin market is anticipated to grow significantly over the forecast period. In 2022, the market size was valued at USD 7.42 billion and is expected to reach USD 10.93 billion by 2030, with a CAGR of 5.05% during the forecast period[5].

Segmentation and Growth Drivers

The market is segmented based on product type (unfractionated heparin, low molecular weight heparin, and ultra-low molecular weight heparin), mode of administration (oral and parenteral), source (bovine and porcine), and application (pre-surgical procedures, post-surgical procedures, kidney dialysis, etc.). The growth is driven by rising clinical trials, product innovations, and technological advancements. Increasing research and development activities, along with rising drug approvals and launches, are also propelling the market's growth[5].

Heparin Sodium Injection Market

The heparin sodium injection market, specifically, is expected to grow at a faster pace. The market is categorized based on application (treatment of venous thromboembolism, complications of pregnancy, cardioversion of atrial fibrillation/flutter, etc.) and product concentration (1,000 USP Units/mL, 5,000 USP Units/mL, 10,000 USP Units/mL, etc.). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa are also key segments[2].

Market Projections

Forecast Period and Growth Rate

The global heparin market, including heparin sodium injections, is projected to grow steadily from 2023 to 2030. The increasing demand for anticoagulants in various medical procedures and the rising incidence of thromboembolic disorders are key factors driving this growth. Technological advancements and investments in emerging markets are also expected to provide beneficial opportunities for market players[5].

Challenges and Restraints

Despite the positive outlook, the market faces challenges such as the high cost associated with heparin products. This can limit accessibility in some regions and affect market penetration. However, ongoing research and development are likely to address these challenges by introducing more cost-effective and efficient products[5].

Dosage and Administration

Recommended Dosages

Heparin sodium in 0.45% sodium chloride injection is indicated for various anticoagulant uses. The recommended adult dosages include:

• 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, followed by 20,000 to 40,000 units per 24 hours.
• Intravascular via Total Body Perfusion: Not less than 150 units/kg; adjust for longer procedures[3].

Adverse Reactions and Precautions

Common Adverse Reactions

The most common adverse reactions associated with heparin sodium include hemorrhage, thrombocytopenia, HIT (with or without thrombosis), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. Patients over 60 years of age may have higher plasma levels of heparin and longer activated partial thromboplastin times (APTTs) compared to younger patients[3].

Conclusion

Heparin sodium, particularly the formulation of 10,000 units in sodium chloride 0.45%, remains a vital anticoagulant in modern medicine. Ongoing clinical trials, such as the Phase I study by União Química, are ensuring that new products meet stringent safety and efficacy standards. The market for heparin sodium injections is poised for significant growth, driven by increasing demand and technological advancements. However, challenges such as high costs need to be addressed to fully realize the market's potential.

Key Takeaways

• Clinical Trials: Ongoing Phase I studies are evaluating the pharmacodynamic and pharmacokinetic profiles of heparin sodium in humans.
• Market Growth: The global heparin market is expected to grow from USD 7.42 billion in 2022 to USD 10.93 billion by 2030.
• Dosage and Administration: Specific dosages for intermittent and continuous intravenous injections, as well as total body perfusion, are well-defined.
• Adverse Reactions: Common adverse reactions include hemorrhage, thrombocytopenia, and hypersensitivity reactions.
• Market Challenges: High costs associated with heparin products are a significant restraint.

FAQs

What is the primary objective of the Phase I study on heparin sodium by União Química?

The primary objective is to determine the pharmacodynamic profile and build a pharmacokinetic profile of heparin sodium of porcine origin when administered intravenously in humans[1].

What are the recommended adult dosages for heparin sodium in 0.45% sodium chloride injection?

The recommended dosages include an initial dose of 10,000 units for intermittent intravenous injection, and 5,000 units for continuous intravenous infusion, with adjustments based on patient needs[3].

What are the common adverse reactions associated with heparin sodium?

Common adverse reactions include hemorrhage, thrombocytopenia, HIT (with or without thrombosis), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels[3].

What is the projected growth rate of the global heparin market?

The global heparin market is expected to grow at a CAGR of 5.05% from 2022 to 2030[5].

What are the key drivers of the heparin sodium injection market growth?

Key drivers include rising clinical trials, product innovations, technological advancements, and increasing research and development activities[5].

Sources

1. Study With Heparin Sodium in Intravenous Administration. CTV Veeva, October 15, 2019.
2. Global Heparin Sodium Injection Market Size and Forecast. Market Research Intellect, December 2024.
3. Heparin Sodium in 0.45% Sodium Chloride Injection. Pfizer Medical Information, July 2024.
4. Study With Heparin Sodium in Intravenous Administration. Network of Care, February 20, 2021.
5. Global Heparin Market – Industry Trends and Forecast to 2030. Data Bridge Market Research.