You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Heparin Sodium 25,000 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%

Condition Name

Condition Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Intervention Trials
Thrombosis 4
Covid19 4
Myocardial Infarction 4
Healthy 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Intervention Trials
Thrombosis 13
Venous Thrombosis 7
Acute Kidney Injury 6
COVID-19 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%

Trials by Country

Trials by Country for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Location Trials
United States 44
China 16
Canada 14
Brazil 12
Germany 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Location Trials
California 7
New York 5
Texas 4
Ohio 3
Pennsylvania 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Clinical Trial Phase Trials
Phase 4 27
Phase 3 15
Phase 2/Phase 3 6
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Clinical Trial Phase Trials
Completed 47
Unknown status 13
Withdrawn 10
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%

Sponsor Name

Sponsor Name for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Sponsor Trials
Ain Shams University 5
GlaxoSmithKline 4
Azidus Brasil 4
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
Sponsor Trials
Other 143
Industry 35
NIH 5
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Heparin Sodium 25,000 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 intestinal mucosa. It is indicated for the prevention and treatment of blood clots and is administered via various routes, including intravenous (IV) and subcutaneous (SC) injections[3][4].

Clinical Uses and Dosing Regimens

Indications

Heparin sodium is used for several clinical indications, including the prevention of thromboembolism, treatment of deep vein thrombosis, and management of acute coronary syndromes. For patients with peripheral artery disease (PAD), heparin dosing can vary based on the clinical presentation:

  • Asymptomatic PAD: Heparin may not be routinely used but can be considered in high-risk patients.
  • Chronic Symptomatic PAD: Heparin can be used peri-procedurally during endovascular interventions[1].

Dosing Regimens

The dosing regimens for heparin sodium are as follows:

  • Deep Subcutaneous Injection:

    • Initial dose: 5000 units by IV, followed by 10,000 to 20,000 units of concentrated solution SC.
    • Maintenance: 8,000 to 10,000 units every 8 hours[1][3].
  • Intermittent IV Injection:

    • Initial dose: 10,000 units.
    • Maintenance: 5,000 to 10,000 units every 4 to 6 hours[3].
  • Continuous IV Infusion:

    • Initial dose: 5,000 units by IV injection.
    • Maintenance: 20,000 to 40,000 units/24 hours in 1000 mL of 0.9% sodium chloride solution[3].

Clinical Trials Update

While specific clinical trials focused solely on heparin sodium 25,000 units in sodium chloride 0.45% may not be widely reported, several studies and guidelines provide insights into its use:

  • Peripheral Artery Disease (PAD): Studies like those by Mazzolai et al. and Qureshi et al. highlight the use of heparin in PAD management, particularly during endovascular interventions. These studies suggest that heparin dosing can vary, but a common approach includes a bolus of 5000 IU followed by continuous infusion adjusted based on activated partial thromboplastin time (aPTT) or activated clotting time (ACT)[1].

  • General Anticoagulation: Clinical practice guidelines and systematic reviews consistently support the use of heparin in various anticoagulation scenarios, emphasizing the importance of monitoring and adjusting doses based on patient response[1][3].

Market Analysis

Global Market Size and Growth

The global heparin market is experiencing significant growth:

  • Current Market Size: The global heparin market was estimated at USD 5.76 billion in 2023[5].
  • Projected Market Size: It is expected to reach USD 9.72 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.41% from 2024 to 2033[5].

Regional Market Insights

  • North America: This region holds the largest market share, with the U.S. heparin market size reaching USD 2.22 billion in 2023 and projected to grow to USD 3.89 billion by 2033 at a CAGR of 5.78%[5].
  • Asia-Pacific: This is the fastest-growing market, driven by increasing healthcare expenditure and a growing demand for anticoagulant therapies[5].

Market Segments

The heparin market is segmented by type (unfractionated heparin, low molecular weight heparin, ultra-low molecular weight heparin), route of administration (intravenous, subcutaneous), packaging (glass, plastic), and other factors. The demand for heparin sodium in sodium chloride solutions, particularly in IV formulations, remains strong due to its efficacy and convenience[5].

Market Projections

Increasing Demand

The increasing incidence of cardiovascular diseases and the need for effective anticoagulation therapies are driving the demand for heparin sodium. The growing elderly population, who are more prone to thromboembolic events, also contributes to the rising demand[5].

Competitive Landscape

The market is competitive with several manufacturers offering heparin sodium products. Companies like Pfizer, MITS, and Primus Pharmaceuticals are key players, offering a range of heparin sodium formulations, including those in sodium chloride solutions[2][3].

Pricing and Availability

The pricing of heparin sodium injections varies by region and manufacturer. For example, in India, heparin sodium injections can range from ₹ 50 to ₹ 320 per unit, depending on the strength and packaging[2].

Safety and Precautions

Adverse Reactions

Common adverse reactions to heparin sodium include hemorrhage, thrombocytopenia, heparin-induced thrombocytopenia (HIT), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels[3].

Overdosage

Bleeding is the chief sign of heparin overdosage. Symptoms may include nosebleeds, blood in urine, or tarry stools. Monitoring of activated partial thromboplastin time (aPTT) and appropriate dose adjustments are crucial to avoid overdosage[3].

Key Takeaways

  • Clinical Uses: Heparin sodium is used for preventing and treating blood clots, with specific dosing regimens for different clinical scenarios.
  • Market Growth: The global heparin market is projected to grow significantly, driven by increasing demand for anticoagulant therapies.
  • Regional Insights: North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.
  • Safety: Monitoring and appropriate dose adjustments are critical to avoid adverse reactions and overdosage.

FAQs

What are the common indications for heparin sodium?

Heparin sodium is used to prevent blood clots, treat deep vein thrombosis, and manage acute coronary syndromes.

What are the typical dosing regimens for heparin sodium?

Dosing regimens include initial and maintenance doses via IV and SC routes, with specific guidelines for different clinical scenarios such as PAD.

What is the projected growth of the global heparin market?

The global heparin market is expected to grow from USD 5.76 billion in 2023 to USD 9.72 billion by 2033 at a CAGR of 5.41%.

Which region has the largest market share for heparin?

North America, particularly the U.S., holds the largest market share for heparin.

What are the common adverse reactions to heparin sodium?

Common adverse reactions include hemorrhage, thrombocytopenia, HIT, local irritation, and hypersensitivity reactions.

Sources

  1. University of Illinois at Chicago, College of Pharmacy: "What heparin dosing regimens should be used for indications related to peripheral artery disease?"[1]
  2. IndiaMART: "Heparin Injection - Heped 25 Latest Price, Manufacturers & Suppliers"[2]
  3. Pfizer Medical Information: "Heparin Sodium in 0.45% Sodium Chloride Injection"[3]
  4. ColumbiaDoctors: "Heparin Sodium, Porcine Prefilled Syringe"[4]
  5. Precedence Research: "Heparin Market Size to Hit USD 9.72 billion by 2033"[5]
Last updated: 2025-01-16

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.