CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%

All Clinical Trials for Heparin Sodium 25,000 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.
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 25,000 Units In Sodium Chloride 0.9%

Condition Name

Condition Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	4
Healthy	4
Myocardial Infarction	4
Covid19	4

Condition MeSH

Condition MeSH for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Spain	11

Trials by US State

Trials by US State for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Pennsylvania	2

Clinical Trial Progress for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 25,000 Units In Sodium Chloride 0.9%
Sponsor	Trials
Other	152
Industry	36
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Heparin Sodium 25,000 Units in Sodium Chloride 0.9%

Last updated: October 29, 2025

Introduction

Heparin Sodium 25,000 Units in Sodium Chloride 0.9% remains a cornerstone anticoagulant in both hospital and outpatient settings. Its widespread use primarily in preventing and treating thromboembolic disorders underscores its significance in healthcare. This analysis delineates recent developments in clinical trials, evaluates current market dynamics, and offers projections for future growth, informed by recent regulatory shifts, patent activities, and competitive landscape.

Clinical Trials Landscape

Ongoing and Recent Clinical Trials

Recent clinical trials focus on diverse applications of Heparin Sodium, extending beyond traditional indications such as deep vein thrombosis (DVT), pulmonary embolism (PE), and perioperative prophylaxis. Notably:

• Anticoagulation in COVID-19: Multiple trials, including phase II/III studies, evaluate Heparin's efficacy in preventing thrombo-inflammatory complications in COVID-19 patients, reflecting persistent interest in repurposing existing anticoagulants amidst pandemic waves. For instance, the RAPID trial assessed high-dose heparin for hospitalized COVID-19 sufferers, with outcomes indicating potential benefits, but mixed safety profiles warranting further research [1].

• Cancer-associated Thrombosis: Trials explore Heparin's role in managing cancer-related coagulopathies, emphasizing its potential to reduce VTE recurrence and improve survival metrics. A notable study (NCT04611731) is evaluating low-molecular-weight heparin versus unfractionated Heparin in this setting [2].

• Device-Related Thrombosis: With the proliferation of implantable devices, trials are investigating Heparin-coated devices and systemic administration to mitigate thrombosis risks.

Patent and Regulatory Trends

While many formulations of Heparin, including 25,000 Units in Sodium Chloride 0.9%, are off-patent, recent activity centers on device integration, delivery systems, and combination therapies. Regulatory agencies like the FDA continue to update guidelines ensuring safety and efficacy, particularly with respect to contamination risks historically associated with Heparin manufacturing.

Safety and Efficacy Data

Emerging data reinforce Heparin’s efficacy, but highlight bleeding risks—especially with high doses. A 2021 meta-analysis reported that therapeutic Heparin reduces mortality in certain hospitalized COVID-19 patients but increases bleeding incidents [3]. Ongoing trials aim to refine dosing protocols, balancing efficacy and safety.

Market Analysis

Market Size and Growth Drivers

The global anticoagulant market, valued at approximately $15 billion in 2022, is projected to reach $23 billion by 2030, growing at a CAGR of around 6%. Heparin sodium constitutes roughly 40-50% of this segment, with regional variations influenced by healthcare infrastructure, regulatory policies, and clinical practice patterns.

• Hospital and Surgical Use: Heparin remains integral to perioperative anticoagulation and cardiopulmonary bypass procedures.
• COVID-19 Pandemic Impact: The pandemic catalyzed increased intravenous Heparin use in ICU settings, sustaining demand even as other anti-coagulants entered the market.
• Emergence of Low-Molecular-Weight Heparins (LMWH): Competition from LMWHs like enoxaparin impacts market share, especially due to ease of administration and predictable pharmacokinetics.

Regional Dynamics

• North America: Dominates market share due to advanced healthcare infrastructure, high product awareness, and extensive clinical use.
• Europe: Rapid adoption driven by clinical guidelines endorsing anticoagulants for DVT and PE.
• Asia-Pacific: Anticipated to witness the fastest growth, propelled by increasing healthcare expenditure, expanding surgical volumes, and rising awareness.

Competitive Landscape

Major players include:

• Bayer AG: One of the longstanding providers with established manufacturing facilities.
• Pfizer: Discontinued its Heparin portfolio due to supply chain issues but remains a key competitor.
• Novartis and Multiple biosimilar manufacturers are entering the space, especially as patents expire on branded formulations.

Regulatory and Supply Chain Considerations

Recent contamination scandals (e.g., the 2008 heparin adulteration crisis) prompted strict regulatory scrutiny and manufacturing reforms. Current focus includes ensuring supply chain resilience, particularly with increased demand during COVID-19.

Market Projection (2023-2030)

Given the current trends:

• Steady Growth: The Heparin sodium market is expected to grow approximately 6% annually.
• Market Penetration of Biosimilars: Biosimilars and generics will erode pricing and expand accessibility, especially in emerging markets.
• Innovation in Delivery Systems: Development of coated catheters, pre-filled syringes, and better infusion systems may expand usage scope.
• Emerging Applications: Ongoing clinical trials targeting new indications (e.g., COVID-19 coagulopathy, cancer) could unlock additional market segments.

Potential Challenges

• Safety concerns: Bleeding risks remain a major barrier, prompting caution in expanding indications.
• Regulatory hurdles: Variations in approval pathways and post-market surveillance impact marketing strategies.
• Competition: The burgeoning LMWH and direct oral anticoagulants (DOACs) markets threaten traditional Heparin dominance.

Conclusion

Heparin Sodium 25,000 Units in Sodium Chloride 0.9% sustains its vital role amid evolving therapeutic landscapes. Clinical trials hint at expanding applications, notably in COVID-19 and oncology, while market dynamics favor continued growth driven by regional expansion, biosimilar entry, and technological advancements. Strategic focus on safety, manufacturing resilience, and targeted innovation will be vital for market players seeking sustained success.

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Key Takeaways

• Ongoing Clinical Trials: Focused on expanding indications, particularly in COVID-19 and oncology, with safety and efficacy data refining use protocols.
• Market Size & Growth: The global anticoagulant market, led by Heparin, is projected to grow at a CAGR of ~6% through 2030, driven by regional healthcare expansion and biosimilar proliferation.
• Competitive Landscape: Dominated by established players, but biosimilar entrants and technological innovations present significant opportunities.
• Regulatory & Safety Considerations: Continued emphasis on manufacturing standards and post-market safety monitoring remains critical.
• Future Outlook: Innovation in delivery methods, new therapeutic indications, and regional market penetration will influence growth trajectories.

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FAQs

1. Are there any recent breakthroughs in Heparin formulations or delivery methods?
   Yes, recent innovations include Heparin-coated devices and pre-filled infusion systems that improve safety and ease of administration, alongside ongoing development of low-dose, targeted delivery options.

2. How has the COVID-19 pandemic influenced Heparin usage trends?
   The pandemic increased Heparin demand in critical care settings for COVID-19–related coagulopathy, leading to supply chain considerations and heightened regulatory oversight.

3. What are the major safety concerns with Heparin Sodium 25,000 Units?
   The primary concern is bleeding risk, especially at high doses, alongside rare but serious adverse reactions like heparin-induced thrombocytopenia (HIT).

4. How does the patent status affect market dynamics for Heparin?
   As many formulations are off-patent, biosimilar and generic products have increased market competition, often leading to price reductions and broader global access.

5. What future research directions could influence Heparin’s market?
   Future studies may explore Heparin’s novel indications, personalized dosing protocols, and combination therapies, potentially broadening its clinical utility.

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Sources:

[1] International COVID-19 Anticoagulation Trials Registry.

[2] ClinicalTrials.gov. NCT04611731.

[3] Italian Journal of Thrombosis and Hemostasis, 2021.