Protamine dose options to reverse heparin after open‑heart bypass
Official title: Lower Protamine Dose for Reversal of Heparin After Cardiopulmonary Bypass: Is it Safe? Comparative Prospective Randomized Trial.
Run by Sohag University · NCT07477977 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 195 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | June 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07477977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
See if virtual reality headsets can help with pain and anxiety after open-heart surgery
This randomized trial tests whether using virtual reality headsets after open-heart surgery reduces pain and anxiety and improves satisfaction and physiological measures compared with standard care.
-
See if hypotension during anesthesia induction relates to tissue oxygen in open-heart surgery
This study tests whether post-induction hypotension in open-heart surgery patients can be predicted using arterial and tissue oxygenation measures.
-
Box breathing before chest tube removal after open-heart surgery
This trial tests whether performing a 5-minute box breathing session before chest tube removal reduces pain, anxiety, and breathlessness in adults who had open-heart surgery.
-
IV pain medicine, thoracic epidural, and erector spinae plane block for long-term pain after open-heart surgery
This study will compare three common pain-control approaches—IV pain medicines, thoracic epidural, and erector spinae plane block—to see if one lowers chronic pain three months after open-heart surgery.
-
Low-Flow Anesthesia in Open-Heart Surgery
This study tests whether different fresh gas flow rates during open-heart surgery with low-flow anesthesia affect patient hemodynamics.
-
Using kidney Doppler and urine oxygen to predict acute kidney injury after open heart surgery
This tests whether kidney Doppler measurements and urine oxygen levels can predict acute kidney injury in adults having elective on-pump open heart surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.