Protamine dose options to reverse heparin after open‑heart bypass
Lower Protamine Dose for Reversal of Heparin After Cardiopulmonary Bypass: Is it Safe? Comparative Prospective Randomized Trial.
This trial will test three different protamine dosing ratios (1:1, 0.8:1, and 0.75:1) to see which safely and effectively reverses heparin in adults having elective open‑heart surgery with cardiopulmonary bypass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07477977 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double‑blind trial will enroll adults undergoing elective cardiac surgery with cardiopulmonary bypass and randomize them to receive protamine at one of three protamine‑to‑heparin ratios (1:1, 0.8:1, or 0.75:1) based on the initial heparin dose. The primary outcome is activated clotting time (ACT) measured 5 minutes after protamine administration. Secondary outcomes include need for additional protamine, protamine‑related adverse events, postoperative bleeding, blood transfusion requirements, and hospital length of stay. The approach seeks to determine whether lower protamine doses achieve adequate heparin reversal while reducing protamine‑related complications.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve, or combined procedures) who can provide informed consent are ideal candidates.
Not a fit: Patients with known protamine allergy, preexisting coagulopathy, inability to stop chronic anticoagulation, severe renal or hepatic dysfunction, pregnant patients, emergency surgeries, or those undergoing off‑pump procedures are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce excess protamine exposure and lower the risk of bleeding, platelet dysfunction, hemodynamic instability, and transfusion needs after bypass.
How similar studies have performed: Prior smaller trials and observational studies have suggested reduced protamine dosing can adequately reverse heparin with fewer side effects, but the optimal protamine‑to‑heparin ratio remains uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve surgery, or combined procedures) * Patients receiving systemic heparinization according to the institutional cardiopulmonary bypass protocol * Ability to provide written informed consent before surgery Exclusion Criteria: * Known allergy or hypersensitivity to protamine * Pre-existing coagulopathy or bleeding disorders * Patients receiving chronic anticoagulation that cannot be safely discontinued before surgery * Severe renal dysfunction * Severe hepatic dysfunction * Emergency cardiac surgery * Pregnancy * Off-pump cardiac surgery
Where this trial is running
Sohag
- Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Principal investigator: Asmaa S Farghaly, MD — Faculty of Medicine, Sohag University
- Study coordinator: Asmaa S Farghaly, MD
- Email: asmaasaad@med.sohag.edu.eg
- Phone: +20 10 20283823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.