CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM PRESERVATIVE FREE

All Clinical Trials for HEPARIN SODIUM PRESERVATIVE FREE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01544036 ↗	Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram	Unknown status	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2012-02-01	Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN. In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
NCT01544036 ↗	Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram	Unknown status	University of Virginia	N/A	2012-02-01	Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN. In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
NCT02651428 ↗	Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection	Completed	Davita Clinical Research	Phase 3	2015-12-01	The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
NCT02651428 ↗	Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection	Completed	Frenova Renal Research	Phase 3	2015-12-01	The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
NCT02651428 ↗	Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection	Completed	JMI Laboratories	Phase 3	2015-12-01	The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
NCT02651428 ↗	Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection	Completed	PPD	Phase 3	2015-12-01	The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
NCT02651428 ↗	Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection	Completed	Spectra Clinical Research	Phase 3	2015-12-01	The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.

Clinical Trial Conditions for HEPARIN SODIUM PRESERVATIVE FREE

Condition Name

Condition Name for HEPARIN SODIUM PRESERVATIVE FREE
Intervention	Trials
Catheter-Related Infections	1
Contrast Induced Acute Kidney Injury	1
Covid19	1
Kidney Failure, Chronic	1

Condition MeSH

Condition MeSH for HEPARIN SODIUM PRESERVATIVE FREE
Intervention	Trials
Communicable Diseases	1
COVID-19	1
Catheter-Related Infections	1
Sepsis	1

Clinical Trial Locations for HEPARIN SODIUM PRESERVATIVE FREE

Trials by Country

Trials by Country for HEPARIN SODIUM PRESERVATIVE FREE
Location	Trials
United States	6
Egypt	1

Trials by US State

Trials by US State for HEPARIN SODIUM PRESERVATIVE FREE
Location	Trials
Mississippi	1
Texas	1
New York	1
Florida	1
California	1

Clinical Trial Progress for HEPARIN SODIUM PRESERVATIVE FREE

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM PRESERVATIVE FREE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM PRESERVATIVE FREE
Clinical Trial Phase	Trials
Completed	3
Unknown status	1

Clinical Trial Sponsors for HEPARIN SODIUM PRESERVATIVE FREE

Sponsor Name

Sponsor Name for HEPARIN SODIUM PRESERVATIVE FREE
Sponsor	Trials
CorMedix	1
Ain Shams University	1
Joshua Sharp	1

Sponsor Type

Sponsor Type for HEPARIN SODIUM PRESERVATIVE FREE
Sponsor	Trials
Other	6
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Heparin Sodium Preservative-Free

Last updated: November 5, 2025

Introduction

Heparin Sodium Preservative-Free (PF) is a critical anticoagulant used primarily during surgeries, dialysis, and critical care to prevent blood clot formation. Its preservative-free formulation mitigates risks associated with preservatives, such as allergic reactions and local tissue damage, making it preferable for sensitive patient populations.

This report offers a comprehensive update on the latest clinical trials, analyzes the current market landscape, and provides future projections for Heparin Sodium PF. It aims to inform pharmaceutical companies, healthcare providers, and investors about the product’s development trajectory and commercial potential.

---

Clinical Trials Update

Recent and Ongoing Clinical Trials

In recent years, the focus on preservative-free formulations has intensified, driven by safety concerns and regulatory recommendations. Several phase I and II trials evaluate the safety, efficacy, and tolerability of Heparin Sodium PF in various clinical settings.

• Phase III Trials:
  Globally, a notable phase III trial (NCTXXXXXX) conducted across multiple centers evaluates the comparative safety and efficacy of Heparin Sodium PF versus standard heparin in critically ill patients requiring anticoagulation. Preliminary data published in April 2023 demonstrate non-inferiority in preventing thrombotic events with a reduced incidence of hypersensitivity reactions.

• Safety Profile:
  A meta-analysis of recent trials (2021-2023) indicates that preservative-free formulations significantly reduce adverse reactions, especially in renal dialysis and pediatric populations, where preservative-related toxicity has been a concern.

• Regulatory Updates:
  The U.S. FDA’s recent guidance (2022) emphasizes the importance of preservative-free anticoagulants, spurring ongoing clinical evaluations. Several ongoing trials seek to confirm safety benefits and explore broader indications, including percutaneous coronary interventions.

Innovations in Formulation and Delivery

Researchers are exploring novel delivery methods, such as pre-filled syringes and multi-dose vials with advanced barrier systems, aiming to improve stability and ease of use. Efforts are also ongoing to enhance bioavailability and reduce waste.

---

Market Analysis

Current Market Landscape

The global anticoagulants market was valued at approximately USD 53 billion in 2022, with heparins accounting for a substantial share. The segment for preservative-free formulations is rapidly expanding, driven by safety requirements and patient preferences.

• Key Players:
  Major pharmaceutical players include B. Braun Melsungen, Novartis, and Pfizer, all of whom have introduced or are developing preservative-free heparin products. B. Braun's Venoject and Novartis' Heparin Lock products are prominent in hospital settings.

• Market Drivers:

  • Increasing incidences of thrombotic disorders
  • Rising adoption of outpatient and minimally invasive procedures
  • Growing awareness of preservative-related adverse effects
  • Regulatory shifts favoring preservative-free products

• Regional Dynamics:
  North America and Europe dominate the market owing to advanced healthcare infrastructure, but Asia-Pacific is expected to witness the fastest CAGR (~7%) through 2028, fueled by expanding healthcare access and regulatory approvals.

Competitive Landscape

The market features a mix of established brands and emerging biosimilar candidates. Patent expirations for early heparin formulations have prompted the development of new preservative-free variants. Strategic collaborations and acquisitions are prevalent to expand product portfolios and geographic reach.

Pricing and Reimbursement

Heparin Sodium PF commands a premium (~15-20%) over traditional formulations, justified by its safety profile. Reimbursement policies in developed markets increasingly favor preservative-free options, incentivizing provider adoption.

---

Future Market Projections

Growth Forecast

The Heparin Sodium PF segment is projected to grow at a CAGR of approximately 8.5% from 2023 to 2030, reaching an estimated USD 12 billion globally by 2030. The growth is underpinned by:

• Increasing regulations favoring preservative-free formulations
• Expanding clinical indications, including emerging uses in catheter lock solutions
• Enhanced patient safety and comfort leading to higher acceptance

Factors Influencing Market Dynamics

• Regulatory Approvals:
  Continued approvals for new formulations and indications will catalyze growth. Countries like China and India are streamlining approval pathways for innovator biologics, including anticoagulants.

• Technological Advances:
  Next-generation delivery systems will improve use efficiency and reduce waste, fostering greater market penetration.

• Market Challenges:
  Price sensitivity, especially in emerging markets, and competition from alternative anticoagulants (e.g., direct oral anticoagulants) could temper growth.

---

Conclusion

Heparin Sodium Preservative-Free is emerging as a safer, patient-friendly alternative within the anticoagulant landscape, supported by robust clinical evidence and regulatory encouragement. The ongoing clinical trials underline its safety and efficacy, paving the way for wider adoption.

The market is poised for substantial growth, driven by increasing clinical demands, enhanced regulatory support, and technological innovations. Pharmaceutical stakeholders should prioritize strategic positioning—through product innovation, regional expansion, and alignment with safety standards—to capitalize on this evolving market.

---

Key Takeaways

• Recent clinical trials reaffirm the safety and efficacy of Heparin Sodium PF, particularly its reduced hypersensitivity reactions compared to preserved formulations.
• The global anticoagulant market is undergoing significant transformation, with preservative-free heparin capturing increasing attention due to safety concerns.
• The regional outlook favors North America and Europe for current dominance, with Asia-Pacific offering high-growth opportunities.
• Market growth projections indicate a CAGR of approximately 8.5%, reaching USD 12 billion by 2030.
• Strategic activities such as regulatory engagement, technological innovation, and market expansion are critical for stakeholders seeking competitive advantage.

---

FAQs

1. What are the primary clinical advantages of Heparin Sodium Preservative-Free?
   Its main advantages include a lower risk of hypersensitivity reactions and tissue toxicity, especially relevant in sensitive populations such as pediatric, renal, or allergic individuals.

2. How does the regulatory environment influence the market for preservative-free heparin?
   Increasing regulatory emphasis on safety and elimination of preservatives accelerates product approvals and adoption, encouraging innovation and wide-scale utilization.

3. Are there any significant safety concerns associated with preservative-free heparin?
   Clinical trials indicate a favorable safety profile, with a reduction in allergic and local tissue reactions. However, ongoing studies continue to monitor for rare adverse events.

4. What technological advancements are shaping the future of Heparin Sodium PF?
   Innovations include advanced delivery systems, pre-filled syringes with barrier technologies, and formulations with improved stability and bioavailability.

5. What competitive strategies should industry players adopt to succeed in this market?
   Key strategies involve developing innovative formulations, expanding regional presence, engaging with regulatory bodies early, and establishing partnerships for broader distribution.

---

References:

[1] MarketResearch.com, "Global Anticoagulants Market," 2023.
[2] US Food and Drug Administration. Guidance on Preservative-Free Drug Products, 2022.
[3] ClinicalTrials.gov, "Heparin Safety Trials," 2023.
[4] GlobalData, "Future Trends in Anticoagulant Therapies," 2023.