CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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 DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Covid19	4
Thrombosis	4
Myocardial Infarction	4
Healthy	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	13
Venous Thrombosis	7
Acute Kidney Injury	7
COVID-19	6

Clinical Trial Locations for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
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 DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	152
Industry	36
NIH	5

Last updated: July 28, 2026

Heparin Sodium 25,000 Units in Dextrose 5% in Plastic Container: Clinical Trials Update, Market Outlook, and Revenue Projections

Heparin sodium 25,000 units in dextrose 5% solution in a plastic container is a hospital/infusion product used for anticoagulation and is generally not tracked as a stand-alone “drug launch” asset like a new molecular entity. Public clinical-trial and market reporting is usually aggregated at the level of heparin formulations (unfractionated heparin) or specific label presentations rather than this exact strength-and-solvent container configuration. As a result, a complete, accurate clinical-trials update and numeric market projection tied specifically to the exact SKU cannot be produced from the information available in this feed.

What clinical trials exist for unfractionated heparin in dextrose 5% solutions?

No complete, accurate set of trials can be stated for this exact formulation (heparin sodium 25,000 units in dextrose 5% in a plastic container). Heparin clinical development and evidence generation typically cover unfractionated heparin more broadly, while product-specific studies are uncommon because heparin is an established drug with well-characterized dosing, stability, and administration practices.

Which trial types are most common for heparin sodium (UFH) products?

• Acute coronary syndrome and unstable angina anticoagulation
• Deep vein thrombosis and pulmonary embolism treatment/initial management
• Catheter-related thrombosis prophylaxis/treatment
• Dialysis anticoagulation
• Peri-procedural anticoagulation in cardiology, surgery, and interventional settings
• Use in extracorporeal circuits (ECMO, CRRT), typically protocol-driven

What endpoints drive adoption for UFH hospital infusions?

• Time to therapeutic anticoagulation (APTT/anti-Xa targets where applicable)
• Bleeding incidence and major bleeding endpoints
• Thrombotic event reduction
• Need for dose adjustment and monitoring burden
• Compatibility and administration safety in infusion systems

How big is the market for heparin sodium infusion products, and where does 25,000 units in D5% fit?

A precise market size projection for the exact presentation cannot be computed from the information available in this feed. Market estimates for heparin generally group by “unfractionated heparin” and broader dosage forms (injection, vial/ampul/solution) rather than a single unit-strength in a specific dextrose concentration within a plastic container.

What demand drivers matter for hospital UFH?

• ED and inpatient volume for ACS and VTE pathways
• Catheter and procedural anticoagulation protocols
• Dialysis volumes and growth in ESRD services
• Standard-of-care shifts between UFH and LMWH, and to a smaller extent DOACs, depending on indication and renal function
• Supply reliability and pricing dynamics for sterile injectables

What substitution risks exist that can shrink UFH utilization?

• LMWH uptake in many VTE indications and extended outpatient regimens
• DOAC preferences in selected populations
• Institutional protocol changes that reduce UFH infusion use in favor of alternative anticoagulants

When do clinical protocol shifts or shortages change heparin sodium demand?

A formulation-specific timeline cannot be produced here. However, UFH utilization in the hospital setting can move quickly with:

• Pharmacy formulary changes
• Anticoagulation pathway updates (ACS/VTE)
• Shortage-driven substitution policies across injectable anticoagulants
• Changes in monitoring practices and availability of monitoring capacity

What is the competitive landscape for unfractionated heparin in infusion-ready presentations?

Specific competitors for the exact SKU (heparin sodium 25,000 units in dextrose 5% in plastic container) cannot be enumerated reliably from this feed. In practice, hospital anticoagulant procurement competes across:

• UFH presentations (vials, prefilled syringes, bags)
• Therapeutic alternatives (LMWH, fondaparinux, DOACs)
• Biosupply and sterile manufacturing capacity

How do purchasing decisions typically work for UFH in hospitals?

• Conversion to institutional dosing protocols (weight-based or standardized dosing)
• Availability of ready-to-administer bags or compatible infusion systems
• Inventory turnover and storage constraints
• Unit pricing and contract structures with wholesalers and GPOs

How should revenue projections be modeled for this heparin sodium presentation?

A numeric projection requires baseline data that is not present in this feed (current sales by exact NDC/label presentation, usage per institution, payer mix, and distribution). A complete, accurate projection tied to the specific SKU cannot be provided.

What inputs are required for a defensible SKU-level forecast?

• Exact product identifiers (NDC/label strength, container type)
• Current utilization in target settings (ED, inpatient ACS/VTE, dialysis, procedural)
• Market trend assumptions for UFH vs LMWH/DOAC
• Pricing and reimbursement assumptions by channel
• Supply availability risk and contracting dynamics

What are the main regulatory constraints affecting heparin sodium infusion products?

A formulation-specific regulatory status and pathway analysis cannot be produced from the information available in this feed. UFH products are typically approved via an abbreviated pathway or legacy approvals; however, SKU-level regulatory details depend on the specific application and labeling record tied to the formulation and container.

What drives regulatory and quality scrutiny for sterile anticoagulant solutions?

• Sterility assurance and container closure integrity
• Stability in diluent and compatibility with infusion equipment
• Labeling for infusion preparation, administration route, and monitoring guidance
• Batch consistency and variability controls

What patent or exclusivity events could affect this product’s market share?

A complete patent and exclusivity analysis for the exact formulation cannot be produced from this feed. For older drugs like heparin, exclusivity and patent estates (when present) are typically tied to specific processes, formulations, or manufacturing methods, and a SKU-level mapping requires product-level legal and Orange Book records.

What generic entry risks exist for heparin sodium 25,000 units in dextrose 5% in plastic container?

Generic entry risk is typically low for older, widely available UFH presentations, but it is not possible to state likelihood, timing, or litigation posture for this exact SKU without the relevant NDC-level legal records.

Key Takeaways

• A complete, accurate clinical-trials update and numeric market projection specific to heparin sodium 25,000 units in dextrose 5% in plastic container cannot be produced from the information available in this feed.
• Evidence and adoption for unfractionated heparin are usually tracked at the UFH class or broader presentation level, while demand shifts are driven by hospital anticoagulation protocols, monitoring practices, and substitution patterns versus LMWH and DOACs.
• SKU-level forecasting requires NDC-level sales/utilization and price-contract inputs that are not present here.

FAQs

1. What hospital indications drive the highest UFH utilization in the US?
2. How do unfractionated heparin and LMWH compare for ACS and VTE management in protocols?
3. What monitoring targets (APTT vs anti-Xa) are used with UFH infusion pathways by guideline?
4. How do container and diluent compatibility factors affect IV administration of UFH?
5. What operational risks (sterile supply constraints, shortage substitution) most often impact UFH availability?

References

1. FDA. Guidance for Industry: Warnings and Precautions, and Labeling for Human Prescription Drug and Biological Products. U.S. Food and Drug Administration.
2. EMA. Guideline on the Investigation of Medicinal Products for Bioequivalence. European Medicines Agency.
3. ACC/AHA. Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes. American College of Cardiology/American Heart Association.
4. CHEST/ACCP. Antithrombotic Therapy for VTE Disease. American College of Chest Physicians.