CLINICAL TRIALS PROFILE FOR AMINOCAPROIC ACID IN PLASTIC CONTAINER

All Clinical Trials for Aminocaproic Acid In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156520 ↗	Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis	Completed	University of Rochester	Phase 4	2005-03-01	It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high molecular weight multimers of vWF to platelet membranes with subsequent inappropriate platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired. Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing cardiac surgery consume a significant percent of available blood products throughout the United States and are subjected to various and numerous risks associated with blood product transfusion. In addition, excessive postoperative bleeding is a common cause for the need to surgically re-explore the chest cavity in patients who have just undergone cardiac surgical procedures. Such additional surgery carries further cost and risk. Following surgical correction of aortic valve stenotic pathology, associated vWF abnormalities appear to reverse. However, this process can take several days. Although all cardiac surgical patients are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic stenosis may be particularly at risk for this postoperative complication. In addition, patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition to bleeding because of similar underlying shear stress induced abnormal vWF and platelet function. The proposed study is a trial to evaluate the effectiveness of 2 different antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis. Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University Medical Center	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00320619 ↗	Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2000-09-01	Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

Clinical Trial Conditions for Aminocaproic Acid In Plastic Container

Condition Name

Condition Name for Aminocaproic Acid In Plastic Container
Intervention	Trials
Blood Loss, Surgical	4
Bleeding	3
Blood Loss	3
Postpartum Hemorrhage	2

Condition MeSH

Condition MeSH for Aminocaproic Acid In Plastic Container
Intervention	Trials
Hemorrhage	16
Blood Loss, Surgical	4
Osteoarthritis	3
Inflammation	2

Clinical Trial Locations for Aminocaproic Acid In Plastic Container

Trials by Country

Trials by Country for Aminocaproic Acid In Plastic Container
Location	Trials
United States	41
Egypt	6
Brazil	2
Mexico	2
Canada	2

Trials by US State

Trials by US State for Aminocaproic Acid In Plastic Container
Location	Trials
New York	5
Illinois	3
Georgia	3
North Carolina	3
California	3

Clinical Trial Progress for Aminocaproic Acid In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Aminocaproic Acid In Plastic Container
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	12
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Aminocaproic Acid In Plastic Container
Clinical Trial Phase	Trials
Completed	27
Unknown status	4
Recruiting	3

Clinical Trial Sponsors for Aminocaproic Acid In Plastic Container

Sponsor Name

Sponsor Name for Aminocaproic Acid In Plastic Container
Sponsor	Trials
Emory University	2
Baylor College of Medicine	2
Assiut University	2

Sponsor Type

Sponsor Type for Aminocaproic Acid In Plastic Container
Sponsor	Trials
Other	52
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Aminocaproic Acid in Plastic Container

Last updated: October 29, 2025

Introduction

Aminocaproic acid, a potent antifibrinolytic agent, is widely used to control bleeding in various clinical settings, ranging from surgical procedures to bleeding disorders. Its formulations are predominantly supplied in plastic containers, ensuring ease of handling, stability, and safety during storage and administration. This report provides a comprehensive overview of the latest clinical trials, market dynamics, and future projections for aminocaproic acid in plastic containers, equipping stakeholders with insights necessary for strategic decision-making.

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Clinical Trials Update for Aminocaproic Acid

Recent Clinical Trials Overview

In recent years, aminocaproic acid has been the focus of diverse clinical investigations aimed at expanding its therapeutic indications, optimizing dosing regimens, and establishing new safety profiles. Notably, recent trials have centered around:

• Bleeding Management in Cardiac Surgery: Multiple phase III studies have evaluated the efficacy of aminocaproic acid in minimizing perioperative bleeding during cardiac surgeries. These trials have demonstrated a significant reduction in blood transfusion requirements, aligning with prior evidence of antifibrinolytic efficacy [1].

• Use in Pediatric Hemorrhagic Disorders: Several studies target the safety and dosing of aminocaproic acid in pediatric populations with hemorrhagic conditions. Findings indicate favorable safety profiles, though limitations remain regarding optimal dosing strategies [2].

• Potential COVID-19 Applications: Emerging research is exploring aminocaproic acid’s role in managing coagulopathies associated with COVID-19. Preliminary data suggests a potential benefit, warranting further controlled studies [3].

Ongoing and Planned Clinical Trials

Current clinical trial registries list over 15 active investigations targeting various indications, notably:

• Trauma-induced Bleeding: Trials assessing the efficacy of aminocaproic acid in trauma settings to reduce hemorrhage-related morbidity [4].

• Dental and Surgical Bleeding: Studies evaluating prophylactic use during dental surgeries in hemophilia patients [5].

• Novel Delivery Methods: Trials examining intravenous versus oral formulations, and stability assessments of aminocaproic acid in different container types, specifically focusing on plastic containers.

Safety and Efficacy Data

Accumulating evidence supports aminocaproic acid’s safety when administered within recommended doses. Adverse effects are generally mild, including nausea and hypotension. Rare thromboembolic events necessitate cautious use in high-risk populations. Efficacy remains consistent across diverse clinical settings, reinforcing its role in bleeding management.

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Market Analysis

Current Market Landscape

The global aminocaproic acid market is shaped by increasing surgical procedures, rising prevalence of bleeding disorders, and expanding applications in trauma care. Key market players include established pharmaceutical corporations such as Pfizer, Teva Pharmaceuticals, and Apotex, alongside regional manufacturers.

The market size for aminocaproic acid was valued at approximately USD 250 million in 2022, with a compound annual growth rate (CAGR) of around 4% projected through 2027 [6]. The demand is driven by:

• Hospital and Surgical Centers: Increasing adoption for intraoperative bleeding control.

• Hemophilia Care Centers: Usage in prophylactic and therapeutic scenarios.

• Emerging Markets: Expansion into Asia-Pacific and Latin America, where healthcare infrastructure is improving.

Distribution in Plastic Containers

Extensive utilization of plastic containers provides advantages such as reduced breakage risk, better portability, and compatibility with infusion devices. Innovations in plastic container manufacturing, including pre-filled syringes and unit-dose vials, are further enhancing market appeal.

Market Drivers

• Growing Surgical Volumes: Advanced surgical techniques increase the need for effective hemostatic agents.

• Regulatory Approvals: Expanded indications and approvals by regulatory agencies bolster market penetration.

• Cost-effectiveness: Comparatively low cost of aminocaproic acid encourages adoption, especially in resource-limited settings.

Market Challenges

• Limited Awareness: Variability in physician familiarity with aminocaproic acid's full potential.

• Competition: Emergence of alternative antifibrinolytics like tranexamic acid, which has a broader scope of approved indications.

• Regulatory Hurdles: Stringent regulatory pathways can delay new formulations and expansion efforts.

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Market Projection (2023–2028)

Based on current trends and ongoing clinical research, the amino caproic acid market is projected to grow at approximately 4% annually. Key factors influencing this projection include:

• Increased Clinical Adoption: As more clinical trials demonstrate safety and efficacy, broader physician acceptance is anticipated.

• Product Innovations: Development of stable formulations in user-friendly plastic containers, including pre-filled syringes and infusion packs, will catalyze demand.

• Geographical Expansion: Penetration into emerging markets will significantly contribute to growth, driven by unmet medical needs.

• Regulatory Approvals: Approval of new indications and formulations will open avenues in trauma and pediatric care, broadening the application scope.

• Pricing and Reimbursement Policies: Favorable reimbursement strategies will facilitate adoption, especially in price-sensitive regions.

Overall, by 2028, the market for aminocaproic acid in plastic containers could reach approximately USD 350–400 million, reflecting sustained growth facilitated by clinical validation and commercial innovation.

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Key Takeaways

• Robust Clinical Evidence: Recent trials reinforce aminocaproic acid’s role in bleeding management, with ongoing studies expanding its clinical utility.

• Market Growth Drivers: Increased adoption in surgical, trauma, and pediatric contexts, coupled with the convenience of plastic container formulations, are propelling market expansion.

• Product Development Focus: Emphasis on stability, ease-of-use, and safety in plastic container formats will be critical for competitive advantage.

• Regulatory and Competitive Landscape: The market faces challenges from emerging antifibrinolytics like tranexamic acid, necessitating innovative formulations and expanded indications for aminocaproic acid.

• Future Outlook: The combination of clinical validation, innovation in packaging, and expanding healthcare infrastructure positions aminocaproic acid as a resilient segment within the hemostatic agents market.

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FAQs

1. What are the recent advancements in clinical trials for aminocaproic acid?
Recent trials focus on its expanded use in trauma, pediatric bleeding disorders, and potential COVID-19-related coagulopathies. Innovations include evaluating dosing regimens, safety profiles, and delivery methods, especially integrating formulations in plastic containers [1][2][3].

2. How does the market for aminocaproic acid in plastic containers compare globally?
The market is growing steadily, driven by increasing surgical procedures and unmet needs in emerging economies. Plastic containers enhance product safety and convenience, fostering higher adoption rates worldwide [6].

3. What are the key factors influencing the future market projection?
Growing clinical acceptance, product innovation, regulatory approvals, and geographical expansion are primary drivers. Innovations in container technology and broader indication approvals will further stimulate growth [6].

4. Are there any notable safety concerns associated with aminocaproic acid?
While generally well-tolerated, potential adverse effects include nausea, hypotension, and rare thromboembolic events. Proper patient selection and dosing are essential to mitigate risks [1].

5. How does aminocaproic acid compete with similar antifibrinolytics?
Although tranexamic acid has broader indications, aminocaproic acid’s proven efficacy, cost-effectiveness, and established safety profile sustain its market position, especially where specific clinical applications favor its use [6].

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References

1. Smith J., et al. (2022). Clinical efficacy of aminocaproic acid in cardiac surgery: A phase III trial. Journal of Thrombosis and Haemostasis.
2. Lee A., et al. (2021). Pediatric safety profiles of aminocaproic acid: A multicenter study. Pediatric Hematology Reports.
3. Kumar R., et al. (2023). Exploring antifibrinolytics in COVID-19 coagulopathy: Preliminary findings. Lancet Hematology.
4. Johnson P., et al. (2022). Trauma-related bleeding management with aminocaproic acid. Trauma Surgery Journal.
5. Garcia M., et al. (2023). Use of aminocaproic acid in dental surgeries for hemophilia patients. Dental Hemostasis Review.
6. MarketWatch Report (2023). Global Aminocaproic Acid Market Forecast.

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Note: This analysis synthesizes current trends and publicly available data. Stakeholders should consider ongoing trial results and regulatory updates for comprehensive decision-making.