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Protamine ratio dose
Protamine is a positively charged protein that binds to and neutralizes the anticoagulant effects of heparin by forming an inactive complex.
Protamine is a positively charged protein that binds to and neutralizes the anticoagulant effects of heparin by forming an inactive complex. Used for Reversal of heparin anticoagulation in patients requiring urgent reversal of anticoagulant effects.
At a glance
| Generic name | Protamine ratio dose |
|---|---|
| Sponsor | University of Miami |
| Drug class | Heparin antagonist / Anticoagulant reversal agent |
| Target | Heparin (unfractionated and low-molecular-weight heparin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
Protamine sulfate is used as an antidote to reverse heparin anticoagulation. It works by electrostatically binding to negatively charged heparin molecules, forming a stable complex that is then cleared from the body. The 'ratio dose' refers to dosing calculations based on the amount of heparin that needs to be reversed, typically using a 1:1 mg ratio (1 mg protamine per 100 units of heparin).
Approved indications
- Reversal of heparin anticoagulation in patients requiring urgent reversal of anticoagulant effects
Common side effects
- Hypotension
- Bradycardia
- Dyspnea
- Flushing
- Anaphylaxis (rare)
Key clinical trials
- Dose for Reversal of Heparin After Cardiopulmonary Bypass (NA)
- Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass (PHASE4)
- PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding (PHASE4)
- Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management. (NA)
- Algorithmic Protamine Dosing for Reversal of Heparin After Cardiopulmonary Bypass (NA)
- Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes (PHASE4)
- Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes (PHASE4)
- Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Protamine ratio dose CI brief — competitive landscape report
- Protamine ratio dose updates RSS · CI watch RSS
- University of Miami portfolio CI