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Protamine fixed 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, Management of heparin overdose.
At a glance
| Generic name | Protamine fixed dose |
|---|---|
| Sponsor | University of Miami |
| Drug class | Heparin antagonist / Anticoagulant reversal agent |
| Target | Heparin (unfractionated heparin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
Protamine sulfate is a cationic polypeptide derived from fish sperm that rapidly binds to negatively charged heparin molecules, forming a stable salt complex that is devoid of anticoagulant activity. This reversal of heparin's anticoagulant effect occurs within minutes of intravenous administration. Protamine is used clinically to counteract heparin overdose or to reverse heparin anticoagulation at the end of cardiac surgery or other procedures.
Approved indications
- Reversal of heparin anticoagulation
- Management of heparin overdose
Common side effects
- Hypotension
- Bradycardia
- Dyspnea
- Flushing
- Anaphylaxis (rare)
Key clinical trials
- Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass (PHASE4)
- Anticoagulation Management in Complex Cardiac Surgery (PHASE4)
- Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate (EARLY_PHASE1)
- Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs (PHASE4)
- Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia (PHASE4)
- Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes (PHASE1)
- Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass (PHASE4)
- Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |