CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 12,500 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.

Clinical Trial Conditions for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Healthy	4
Myocardial Infarction	4
Covid19	4
Thrombosis	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 12,500 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 12,500 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 12,500 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 12,500 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	152
Industry	36
NIH	5

Last updated: April 28, 2026

Heparin Sodium 12,500 Units in Dextrose 5% in Plastic Container: Clinical Update, Market Analysis, and Projection

What is this product and what does “clinical update” mean for it?

“Heparin Sodium 12,500 Units in Dextrose 5% in Plastic Container” is a ready-to-use heparin formulation where the anticoagulant (heparin sodium) is dissolved in D5W (5% dextrose) and supplied in a plastic container. In market practice, products in this category typically function as IV heparin infusions for indications such as:

• Acute coronary syndromes and venous thromboembolism management (institutional protocols)
• Anticoagulation in clinical settings (e.g., cardiology, ICU)

A “clinical trials update” for this exact named product is constrained by how the category is typically regulated and studied: heparin itself is established therapy with a long clinical history, while the specific packaging and concentration often do not drive new Phase 3 trials. The most decision-relevant “updates” in such products usually come from:

• Label and guideline changes for heparin use
• Hospital protocol shifts
• Shortage, supply reliability, and manufacturing continuity
• Competitive landscape changes by manufacturer and NDC-level availability

Because no product-specific trial dataset for this exact concentration and container naming was provided, no trial-by-trial update can be stated without risking factual error.

Is there a current clinical trials signal to track for this product?

No complete, product-specific clinical trials record can be produced from the information provided. Heparin sodium is widely studied, but linking those studies to “12,500 Units in Dextrose 5% in Plastic Container” at an NDC/product level requires sourcing that is not present in the prompt.

What drives demand for packaged heparin in D5W?

Demand is driven by institutional anticoagulation workflows and IV compatibility requirements rather than by the novelty of heparin’s mechanism. The strongest operational demand factors are:

• Protocol-based use: Many hospitals run standard heparin infusion protocols for ACS, VTE, and related indications.
• Readiness and handling: Ready-to-use premixed IV heparin reduces compounding and variability versus on-site dilution.
• Supply continuity: Institutions value dependable availability; disruptions can shift usage to alternative concentrations or manufacturers.
• Compatibility decisions: D5W compatibility affects pharmacy workflow, pump programming, and medication system integration.

Who are the typical competitors in this segment?

Competition usually occurs at the level of:

• Heparin sodium IV preparations in premixed diluent (D5W or saline)
• Alternative concentrations and strengths that map to hospital protocol dosing
• Substitution between manufacturers when a specific NDC is constrained

A full competitor list requires NDC-level sourcing not included in the prompt, so only structural competitive patterns can be stated.

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Market analysis: size, segmentation, and pricing drivers

What market is this product in?

This product sits in the broad category of injectable anticoagulants, specifically heparin sodium IV supplied as a premixed, ready-to-use infusion.

For business planning, the relevant market boundaries are:

• Therapeutic market: Anticoagulants (heparin class, IV use)
• Delivery format: IV infusion preparations (premixed vs compounded)
• Care setting: Hospitals and acute care (main demand)

How do hospitals choose between premixed heparin and other options?

Hospital selection is typically optimized across four axes:

• Availability: Premixed product reduces dependence on compounding capacity and reduces variability.
• Dose flexibility: Different heparin strengths can reduce wastage and improve dosing accuracy.
• Total cost to hospital: This includes acquisition cost plus pharmacy labor and compounding materials.
• Therapy mix: Use patterns change with uptake of alternative anticoagulants and shifts in guideline emphasis.

Pricing and reimbursement dynamics

Pricing is generally influenced by:

• Manufacturer and wholesaler contract structure
• Shortage conditions and allocation behavior
• Substitution between NDCs at the pharmacy level
• Competitive entry and discontinuations

Because no pricing history or payer coverage data for this exact named product was supplied, no numeric price trends can be asserted.

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Projection: near-term volume and medium-term trajectory

What baseline should be used to project demand?

For heparin premixed IV products, a reasonable demand model depends on:

• Hospital admissions and acuity for cardiology and thromboembolic disease burden
• Uptake/decline of heparin use versus direct oral anticoagulants (DOACs) and other agents (institution dependent)
• Supply continuity and switching between equivalent products
• Regulatory and guideline effects on IV anticoagulation duration and intensity

What are the credible directional scenarios for this product category?

Without external data, only directionality can be described:

• Stability scenario: Heparin remains protocol standard in many acute settings; usage holds with minor fluctuations.
• Downshift scenario: Increased reliance on alternative anticoagulants reduces heparin exposure in some indications, leading to net volume pressure.
• Upshift scenario: Supply constraints of alternative products or expanded protocol adoption increases heparin utilization.

No quantitative projections can be provided without market sizing data and NDC-level sales history for this exact formulation.

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Key commercial risks specific to premixed heparin

What risks matter most for investors and buyers?

1. Supply risk at the manufacturer level
   • Allocation, production outages, or packaging line disruptions can change availability quickly.
2. Substitution and protocol drift
   • Hospitals can switch to different concentrations or to other diluents if pharmacy workflow requires.
3. Regulatory and labeling updates
   • Even if mechanism is unchanged, label and administration guidance can shift adoption.
4. Competitive pressure
   • Equivalent strength/format products can erode share if they are easier to source or competitively priced.

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Key Takeaways

• The product is a premixed IV heparin sodium formulation in D5W, used in hospital anticoagulation workflows.
• A product-specific clinical trials update cannot be stated from the provided information because no trial or NDC-level source material is available.
• Market demand is driven primarily by hospital protocol reliance, premixed handling benefits, and supply continuity, not by mechanism novelty.
• Quantitative market sizing and numeric projections cannot be produced without sales, utilization, pricing, and competitor/NDC data for the exact formulation.

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FAQs

1. Is heparin sodium 12,500 Units in Dextrose 5% a new drug with active late-stage trials?
   The active substance is established; product-specific late-stage trials are not typically the primary driver unless formulation or delivery changes create new requirements.

2. What determines whether hospitals use this premixed heparin versus alternatives?
   Availability, protocol mapping to strength, pharmacy compounding workflow, and compatibility preferences.

3. Does DOAC adoption reduce heparin IV use?
   It can reduce heparin use in some outpatient or stable indications, but hospitals still use heparin extensively in acute care protocols.

4. What is the biggest operational risk for this product?
   Manufacturer supply continuity and downstream availability can directly affect institutional use.

5. How should investors forecast this category without NDC sales data?
   Use hospital acute-care utilization and anticoagulation protocol adoption assumptions, then stress-test substitution and supply disruption scenarios.

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References

[1] (No external sources were provided in the prompt, so no citations can be produced.)