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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR PROTAMINE SULFATE


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All Clinical Trials for Protamine Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00684450 ↗ Cardiac Surgery: In Vivo Titration of Protamine Completed Organon N/A 2008-06-01 Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary bypass. Each will be randomly assigned to one of two groups. The control group will be submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given during bypass. The test group will receive an infusion of protamine (over 15 minutes) until activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that the optimal protamine to heparin ratio has been attained. The investigators hypothesize this new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its ability to prevent protamine overdose and its deleterious impact on platelet function.15 Principal Objective Evaluate a new in vivo method of titration of protamine sulfate. Secondary Objective Evaluate the impact of this method on the adequacy of heparin neutralization by measuring: 1. platelet count 2. postoperative bleeding 3. transfusion exposure a 4. incidence of heparin rebound
NCT00684450 ↗ Cardiac Surgery: In Vivo Titration of Protamine Completed Montreal Heart Institute N/A 2008-06-01 Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary bypass. Each will be randomly assigned to one of two groups. The control group will be submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given during bypass. The test group will receive an infusion of protamine (over 15 minutes) until activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that the optimal protamine to heparin ratio has been attained. The investigators hypothesize this new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its ability to prevent protamine overdose and its deleterious impact on platelet function.15 Principal Objective Evaluate a new in vivo method of titration of protamine sulfate. Secondary Objective Evaluate the impact of this method on the adequacy of heparin neutralization by measuring: 1. platelet count 2. postoperative bleeding 3. transfusion exposure a 4. incidence of heparin rebound
NCT01006863 ↗ Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study Completed Mansoura University Phase 2 2004-03-01 The prophylactic use of small doses of ephedrine may be effective in obtunding of the hypotension responses to propofol with minimal hemodynamic and ST segment changes. The investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic responses of propofol anesthesia for valve surgery. There is widespread interest in the use of propofol for the induction and maintenance of anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is often associated with a significant rate related transient hypotension for 5-10 minutes. This is mainly mediated with decrease in sympathetic activity with minor contribution of its direct vascular smooth muscle relaxation and direct negative inotropic effects. Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine [10-30 mg] was effective in obtunding the hypotensive response to propofol with associated marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully attenuated, but not abolished, the decrease in blood pressure with transient increase in heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic nerves. Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be clinically insignificant, the investigators postulated that the prophylactic use of small dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for valve surgery with minimal in hemodynamic, ST segment, and troponin I changes. The aim of the present study was to investigate the effects of pre-induction administration of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP), central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac (CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI, respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively) indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with propofol-fentanyl for valve surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Protamine Sulfate

Condition Name

Condition Name for Protamine Sulfate
Intervention Trials
Bleeding 2
Aortic Valve Stenosis 2
Heart Rate 1
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Condition MeSH

Condition MeSH for Protamine Sulfate
Intervention Trials
Aortic Valve Stenosis 2
Transfusion Reaction 1
Hepatitis B 1
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Clinical Trial Locations for Protamine Sulfate

Trials by Country

Trials by Country for Protamine Sulfate
Location Trials
Egypt 7
Netherlands 3
Canada 2
Saudi Arabia 2
United States 1
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Trials by US State

Trials by US State for Protamine Sulfate
Location Trials
Michigan 1
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Clinical Trial Progress for Protamine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Protamine Sulfate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Protamine Sulfate
Clinical Trial Phase Trials
Completed 13
Unknown status 2
Recruiting 1
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Clinical Trial Sponsors for Protamine Sulfate

Sponsor Name

Sponsor Name for Protamine Sulfate
Sponsor Trials
Ain Shams University 4
Wuhan Asia Heart Hospital 1
Lawson Health Research Institute 1
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Sponsor Type

Sponsor Type for Protamine Sulfate
Sponsor Trials
Other 19
Industry 1
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Protamine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Protamine sulfate is a crucial medication used to reverse the anticoagulant effects of heparin, particularly in surgical and medical procedures where heparin is administered to prevent blood clotting. Here, we will delve into the clinical aspects, market analysis, and future projections of protamine sulfate.

Clinical Use and Mechanism of Action

Protamine sulfate is primarily used to neutralize the anticoagulant effect of heparin, which is essential in managing bleeding complications during and after surgical procedures, especially those involving cardiopulmonary bypass and extracorporeal circulation (ECC)[1][3].

Mechanism of Action

Protamine sulfate works by forming an inactive complex with the anionic heparin, thereby neutralizing its anticoagulant effect. This process occurs rapidly, with the onset of action reported within 30 to 60 seconds after intravenous administration, and complete neutralization of heparin typically achieved within five minutes[1].

Clinical Applications

Protamine sulfate is used in various clinical settings, including:

  • Reversal of Heparin Overdose: It is the primary treatment for managing bleeding caused by heparin overdose.
  • Cardiovascular Surgery: Extensively used in heart and aorta surgeries involving ECC.
  • Percutaneous Neurovascular Interventions: Used in cases of bleeding during these procedures[3].

Pharmacodynamics and Pharmacokinetics

Pharmacodynamics

When not complexed with heparin, protamine sulfate itself has a weak anticoagulant effect. It also affects clotting factors such as human factor Xa and antithrombin (AT), promoting the degradation of factor Xa and altering Xa-AT complexes[1].

Pharmacokinetics

The pharmacokinetics of protamine sulfate vary between men and women, with women showing significantly greater plasma clearance and volume of distribution compared to men. The half-life of protamine sulfate is approximately 7.4 minutes in healthy individuals and 4.5 minutes in surgical patients with heparin present[1].

Market Analysis

Current Market Size and Growth

The global protamine sulfate market was valued at USD 350 million in 2023 and is projected to reach USD 520 million by 2031, growing at a compound annual growth rate (CAGR) of 4.3% from 2024 to 2031[2].

Market Segments

The market is segmented based on:

  • Application: Anticoagulant reversal, pharmaceuticals, medical procedures, and cardiovascular treatment.
  • Product: Protamine sulfate injection, powder, solution, tablets, and concentrates.
  • Geography: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2].

Drivers of Market Growth

The market growth is driven by several factors, including:

  • Increasing Cardiovascular Procedures: Rising rates of cardiovascular disorders and improvements in surgical methods.
  • Growing Healthcare Expenditures: Increased spending on advanced treatments and preventive measures.
  • Technological Advancements: Developments in medication formulation and anticoagulant management solutions.
  • Aging Population: The growing geriatric population, which is more susceptible to cardiovascular illnesses[2][5].

Clinical Trials and Research

Ongoing Studies

While there are no recent large-scale clinical trials specifically focused on protamine sulfate, ongoing research continues to explore its effects and optimal dosing. For example, studies have investigated the effects of protamine sulfate on thromboelastography variables for clot formation time and clot strength in different concentrations[4].

Safety and Efficacy

Protamine sulfate is generally safe and effective when used appropriately. However, it can cause adverse effects such as anaphylactic reactions, hypotension, and bronchospasm. The European Medicines Agency (EMA) has established purity specifications and monitoring protocols to ensure the quality and safety of protamine sulfate products[3].

Future Projections

Market Expansion

The protamine sulfate market is expected to continue growing due to the increasing demand for efficient anticoagulant reversal solutions. The expansion will be driven by the rising incidence of cardiovascular diseases, advancements in medical procedures, and the need for better anticoagulant management[2][5].

Technological and Regulatory Developments

Future developments in medication formulation and regulatory updates, such as the revision of the European Pharmacopoeia monograph for protamine sulfate, will play a crucial role in shaping the market. These changes aim to improve the purity and consistency of protamine sulfate products[3].

Key Takeaways

  • Protamine sulfate is a critical medication for reversing heparin's anticoagulant effects.
  • The global market for protamine sulfate is growing, driven by increasing cardiovascular procedures and healthcare expenditures.
  • The medication is used extensively in surgical and medical procedures, particularly in cardiovascular surgery.
  • Ongoing research focuses on optimizing dosing and understanding its effects on clotting factors.
  • Future market growth is anticipated due to technological advancements and regulatory updates.

FAQs

What is the primary use of protamine sulfate?

Protamine sulfate is primarily used to reverse the anticoagulant effect of heparin, especially in surgical procedures and cases of heparin overdose.

How quickly does protamine sulfate take effect?

The onset of action of protamine sulfate is reported within 30 to 60 seconds after intravenous administration, with complete neutralization of heparin typically achieved within five minutes.

What are the main drivers of the protamine sulfate market growth?

The market growth is driven by increasing cardiovascular procedures, growing healthcare expenditures, technological advancements in medication formulation, and the growing geriatric population.

What are the potential adverse effects of protamine sulfate?

Potential adverse effects include anaphylactic reactions, hypotension, and bronchospasm.

How is the purity of protamine sulfate ensured?

The purity of protamine sulfate is ensured through regulatory specifications, such as those set by the European Medicines Agency, which include limits on purity and the use of RP-HPLC methods for analysis[3].

Sources

  1. DrugBank: Protamine sulfate: Uses, Interactions, Mechanism of Action.
  2. Market Research Intellect: Global Protamine Sulfate Market Size and Projections.
  3. EMA: Assessment report for Protamine containing medicinal products.
  4. AVMA Journals: The effects of protamine sulfate on clot formation.
  5. Cognitive Market Research: Global Protamine Sulfate Market Report 2024 Edition.
Last updated: 2025-01-07

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