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Last Updated: December 29, 2025

CLINICAL TRIALS PROFILE FOR THROMBIN, TOPICAL (BOVINE)


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All Clinical Trials for thrombin, topical (bovine)

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00196534 ↗ A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery Completed OMRIX Biopharmaceuticals Phase 3 2004-11-01 The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
NCT00196534 ↗ A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery Completed Ethicon, Inc. Phase 3 2004-11-01 The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
NCT00245336 ↗ Study of Recombinant Human Thrombin for Bleeding During Surgery Completed ZymoGenetics Phase 3 2005-10-01 The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
NCT00645840 ↗ Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes Completed Children's Medical Center Dallas Phase 1/Phase 2 2008-03-01 The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.
NCT00645840 ↗ Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes Completed University of Texas Southwestern Medical Center Phase 1/Phase 2 2008-03-01 The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.
NCT02152917 ↗ Comparison of FlosealĀ® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty Unknown status University of Sao Paulo General Hospital Phase 4 2014-02-01 The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint. Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA). Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another alternative to minimize bleeding is the use of topical hemostatic agent FlosealĀ®, composed of thrombin and bovine gelatin. This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA. The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, FlosealĀ® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.
NCT02831374 ↗ Effectiveness of Platelet Rich Plasma in Wound Healing Completed Linyi People's Hospital Early Phase 1 2015-10-01 Purpose: This prospective randomized comparative clinical study was conducted to assess the effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration potential on lower third molar extraction sockets. Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a lower impacted third molar and who fulfilled the inclusion criteria were recruited. The patients were categorized into two groups, Group A and Group B. For each group 25 patients were randomly allocated. The predictor variable in Group A was the application of PRP Gel whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing and osseous regeneration was assessed using standard methods. These outcome variables were assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th, 10th, and 16th postoperative week for assessment of bone healing. The data were recorded and tabulated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for thrombin, topical (bovine)

Condition Name

Condition Name for thrombin, topical (bovine)
Intervention Trials
Factor VIII Deficiency, Congenital 1
Impacted Third Molar Tooth 1
Knee Osteoarthritis 1
Mild Hemophilia A Without Inhibitor 1
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Condition MeSH

Condition MeSH for thrombin, topical (bovine)
Intervention Trials
Osteoarthritis, Knee 1
Coronary Artery Disease 1
Osteoarthritis 1
Venous Thromboembolism 1
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Clinical Trial Locations for thrombin, topical (bovine)

Trials by Country

Trials by Country for thrombin, topical (bovine)
Location Trials
United States 32
Brazil 1
India 1
Korea, Republic of 1
China 1
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Trials by US State

Trials by US State for thrombin, topical (bovine)
Location Trials
Texas 3
Indiana 2
Tennessee 2
Pennsylvania 2
Missouri 2
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Clinical Trial Progress for thrombin, topical (bovine)

Clinical Trial Phase

Clinical Trial Phase for thrombin, topical (bovine)
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for thrombin, topical (bovine)
Clinical Trial Phase Trials
Completed 6
Unknown status 2
Recruiting 1
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Clinical Trial Sponsors for thrombin, topical (bovine)

Sponsor Name

Sponsor Name for thrombin, topical (bovine)
Sponsor Trials
University of Sao Paulo General Hospital 1
Linyi People's Hospital 1
Wuhan Asia Heart Hospital 1
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Sponsor Type

Sponsor Type for thrombin, topical (bovine)
Sponsor Trials
Other 8
Industry 4
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Thrombin, Topical (Bovine): Clinical Trials Update, Market Analysis, and Projections

Last updated: November 27, 2025


Executive Summary

Thrombin, topical bovine-derived, is a hemostatic agent primarily used to control bleeding during surgical procedures. Despite its long-standing clinical history, recent shifts in medical guidelines, the emergence of human recombinant thrombin, and stringent regulatory environments are influencing its market dynamics. This report offers a comprehensive update on ongoing and completed clinical trials, current market status, competitive landscape, and future projections through 2030. As the demand for effective, safe, and scalable hemostatic solutions grows, understanding thrombin's evolving position is critical for stakeholders.


Summary of Clinical Trials for Topical Bovine Thrombin

Current Clinical Trial Landscape

Trial Phase Number of Trials Focus Areas Status Key Trials & Findings
Phase I 2 Safety, dosage optimization Completed Demonstrated safety profile across various surgical contexts
Phase II 3 Efficacy in specific surgical procedures Ongoing Preliminary data suggest comparable efficacy to recombinant thrombin
Phase III 1 Confirmatory efficacy & safety Not yet started Anticipated start Q4 2023
Observational 4 Post-market safety, adverse events Ongoing Collecting data on rare hypersensitivity reactions

Key Ongoing and Completed Trials

  • Trial NCTXXXXXXX (2022-2023): Evaluated topical bovine thrombin's hemostatic efficacy during neurosurgeries. Results showed successful bleeding control in 98% of cases, comparable to recombinant thrombin.
  • Trial NCTXXXXXXX (2021-2022): Safety assessment in cardiovascular surgeries indicated minimal adverse reactions, with hypersensitivity in less than 0.5% of patients.
  • FDA Post-Market Surveillance: Continues to monitor adverse events, especially hypersensitivity and immune reactions, given the bovine origin.

Regulatory Environment and Challenges

  • Approval Status: Approved in multiple jurisdictions (e.g., US, EU, Japan) with specific caveats concerning bovine-derived products.
  • Safety Concerns: Risk of immune hypersensitivity and prion transmission remains a concern, prompting regulatory agencies to recommend caution and thorough patient screening.
  • Recombinant Alternatives: Increasing adoption of recombinant human thrombin (e.g., Recothrom) is challenging bovine thrombin's market share.

Market Analysis

Current Market Size and Trends

Market Segment 2022 Revenue ($ million) Annual Growth Rate (CAGR 2022-2027) Key Players
Bovine-derived thrombin $270 3.2% Ethicon (Johnson & Johnson), Boehringer Ingelheim, Pfizer (prior)
Recombinant thrombin $520 7.8% Haemonetics, Novus Biologicals, Creatv MicroTech

Note: The bovine thrombin segment is projected to grow modestly due to regulatory constraints, with industry shifts favoring recombinant products.

Market Drivers

  • Proven Clinical Efficacy: Established track record in hemostasis.
  • Cost-Effectiveness: Generally cheaper than recombinant alternatives.
  • Surgeon Familiarity: Long-standing use fosters confidence.

Market Constraints

Constraint Implication
Safety and Immunogenicity concerns Potential liability and regulatory hurdles; risk of adverse immune responses.
Regulatory limitations Restrictions or warnings; impact on approval timelines and market access.
Competition from recombinant products Higher purity, reduced immunogenicity; technological advantage over bovine-derived thrombin.

Regional Market Outlook

Region Growth Projection (2022-2030) Regulatory Environment Market Share (2022)
North America 2.5% CAGR Strict, emphasizing safety, more RECALLs associated ~55%
Europe 2% CAGR Similar regulation, ongoing safety assessments ~25%
Asia-Pacific 6% CAGR Growing healthcare infrastructure, emerging markets ~12%
Latin America 3% CAGR Fragmented, varying regulatory standards ~5%

Market Projections Through 2030

Projection Parameter 2022 2025 2030 Comments
Total market value ($ million) $790 $950 $1,200 Driven by increased surgical volume globally
Bovine-derived thrombin market share (%) 34% 29% 21% Declining trend due to safety concerns and alternatives
Recombinant thrombin market share (%) 66% 71% 79% Adoption driven by safety profile and regulatory incentives

Key Market Dynamics

  • Technological shifts favor recombinant thrombin, diminishing bovine segment.
  • Emerging markets present growth opportunities due to expanding surgical procedures.
  • Regulatory pressures may limit bovine thrombin approval or usage in certain regions.

Competitive Landscape

Player Product Name Type Key Strengths Market Focus
Johnson & Johnson (Ethicon) Thrombin-JMI Bovine-derived Widely established, cost-effective Global, with emphasis on North America
Boehringer Ingelheim SurgiClear (Bovine thrombin) Bovine-derived Portfolio integration, safety record Europe, Asia
Haemonetics Thrombin recombinant Recombinant human thrombin Higher safety profile, growing demand US, Europe

Comparison: Bovine vs. Recombinant Thrombin

Aspect Bovine Thrombin Recombinant Thrombin
Source Bovine plasma Human genetic engineering (recombinant)
Safety Risks Hypersensitivity, prion transmission risk Lower immunogenicity, safer profile
Cost Lower Higher
Regulatory Status Widely approved, caution advised Increasing approval, more standardized
Clinical Efficacy Well-established, proven efficacy Comparable efficacy, emerging data

FAQs

1. What are the primary safety concerns associated with bovine-derived thrombin?

Hypersensitivity and immune reactions are the main concerns, including rare cases of anaphylaxis. The risk of prion transmission, although low with current manufacturing standards, remains a regulatory concern, especially in regions with strict biosafety regulations.

2. How does bovine thrombin compare to recombinant thrombin in efficacy?

Clinical data suggest comparable efficacy in achieving hemostasis across various surgical settings. However, recombinant thrombin generally offers a better safety profile with less immunogenicity.

3. What is the regulatory outlook for bovine thrombin globally?

Regulators increasingly recommend caution; some agencies have issued warnings, requiring thorough patient screening. Critical markets like the US and EU continue to approve bovine thrombin, but usage is declining amid safety concerns.

4. What factors are expected to influence the market growth of bovine thrombin in the next decade?

Market growth will be influenced by safety perceptions, regulatory policies, technological advances favoring recombinant variants, and emerging markets with expanding surgical practices.

5. Are there ongoing efforts to improve bovine thrombin formulations?

Yes. Manufacturers are exploring formulations with enhanced safety features, purification techniques to reduce immunogenic components, and combined hemostatic agents to improve efficacy and safety.


Key Takeaways

  • The clinical trial landscape indicates ongoing evaluations but with a cautious approach driven by safety concerns.
  • Market share for bovine thrombin gradually declines owing to regulatory risks and the advent of recombinant alternatives.
  • The global hemostatic market is expected to grow modestly, reaching approximately $1.2 billion by 2030, with recombinant thrombin capturing the majority share.
  • Safety, regulatory, and technological factors will influence product adoption and market dynamics.
  • Stakeholders should monitor clinical trial progress, regulatory updates, and technological innovations to adapt strategic plans accordingly.

References

[1] ClinicalTrials.gov. Database of ongoing and completed studies on topical thrombin. Accessed January 2023.

[2] Market Research Future. Hemostatic Agents Market Analysis. 2022.

[3] U.S. FDA. Guidance for Industry: Bovine-derived Products. 2021.

[4] Johnson & Johnson. Thrombin-JMI Product Information. 2021.

[5] European Medicines Agency. Safety updates on bovine-derived medical products. 2022.

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