Open Heart SurgeryNCT07477977
Dose for Reversal of Heparin After Cardiopulmonary Bypass
A study testing Protamine sulfate in people with Open Heart Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
Protamine sulfate is routinely used to reverse heparin anticoagulation after cardiopulmonary bypass (CPB). The conventional dosing strategy of 1 mg protamine per 100 IU of heparin may result in excess protamine exposure, which has been associated with anticoagulant effects, platelet dysfunction, and hemodynamic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Protamine sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Asmaa S Farghaly, MD, +20 10 20283823, asmaasaad@med.sohag.edu.eg
About this study
Official title: Lower Protamine Dose for Reversal of Heparin After Cardiopulmonary Bypass: Is it Safe? Comparative Prospective Randomized Trial.
Protamine sulfate is routinely used to reverse heparin anticoagulation after cardiopulmonary bypass (CPB). The conventional dosing strategy of 1 mg protamine per 100 IU of heparin may result in excess protamine exposure, which has been associated with anticoagulant effects, platelet dysfunction, and hemodynamic instability. Recent evidence suggests that lower protamine doses may provide adequate heparin reversal while reducing potential adverse effects. 
This multicenter, prospective, randomized, double-blind, controlled trial aims to compare three protamine-to-heparin dosing ratios (1:1, 0.8:1, and 0.75:1) in adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. The primary outcome is activated clotting time (ACT) measured 5 minutes after protamine administration. Secondary outcomes include the need for additional protamine administration, protamine-related adverse events, postoperative bleeding, blood product transfusion requirements, and length of intensive care unit stay. 
The results of this study may help determine whether reduced protamine dosing can safely achieve effective heparin reversal while minimizing drug exposure and potential complications after cardiopulmonary bypass. 
Read the detailed description
Heparin is routinely administered during cardiopulmonary bypass (CPB) to prevent clot formation in the extracorporeal circuit. At the end of CPB, protamine sulfate is used to neutralize the anticoagulant effect of heparin. The conventional protamine dosing strategy is 1 mg of protamine for every 100 IU of the initial heparin dose administered. However, emerging evidence suggests that this standard dosing regimen may result in excessive protamine exposure, which has been associated with adverse effects such as hypotension, pulmonary hypertension, platelet dysfunction, and paradoxical anticoagulation.
Recent studies have suggested that reduced protamine dosing strategies may achieve adequate reversal of heparin anticoagulation while minimizing potential complications associated with protamine administration. However, the optimal protamine-to-heparin ratio remains uncertain.
This randomized clinical study aims to compare different protamine dosing strategies for heparin reversal after cardiopulmonary bypass in adult patients undergoing cardiac surgery. Participants will be randomized to receive one of three protamine dosing regimens based on the initial heparin dose administered during CPB: the conventional 1:1 ratio (1 mg protamine per 100 IU heparin), a reduced dose ratio of 0.8:1, or a further reduced ratio of 0.75:1.
The study will evaluate the effectiveness of these dosing strategies in achieving adequate heparin reversal as measured by activated clotting time (ACT), as well as clinical outcomes including the need for additional protamine administration, postoperative bleeding, transfusion requirements, protamine-related adverse events, re-exploration for bleeding, and duration of intensive care unit stay.
- Conditions
- Open Heart Surgery
- Being tested
- Protamine sulfate
- Keywords
- Protamine, Heparin, Activated clotting time, Postoperative bleeding, Cardiac surgery
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protamine sulfateDrug
Also called Protamine
Protamine sulfate will be administered intravenously for reversal of heparin anticoagulation after cardiopulmonary bypass. The dose will be calculated according to the randomized study group based on the initial heparin dose administered during cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Standard Protamine Dose (1:1) | Active comparator | Participants will receive protamine sulfate at a ratio of 1 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. Receives: Drug: Protamine sulfate |
| Reduced Protamine Dose (0.8:1) | Experimental | Participants will receive protamine sulfate at a ratio of 0.8 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. Receives: Drug: Protamine sulfate |
| Reduced Protamine Dose (0.75:1) | Experimental | Participants will receive protamine sulfate at a ratio of 0.75 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. Receives: Drug: Protamine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-protamine Activated Clotting Time (ACT)
Activated clotting time measured 5 minutes after completion of protamine administration to assess adequacy of heparin reversal after cardiopulmonary bypass.
Measured: 5 minutes after protamine administration
Secondary outcomes (5)
Need for additional protamine administration
Requirement for additional protamine if activated clotting time exceeds 130 seconds after initial protamine administration.
Measured: 5 minutes after initial protamine administration
Postoperative chest tube drainage
Total volume of chest tube drainage measured during the first 24 hours after cardiac surgery.
Measured: Within 24 hours after surgery
Blood transfusion requirements
Total number of blood product units (red blood cells, fresh frozen plasma, platelets, or cryoprecipitate) transfused within the first 24 hours after surgery.
Measured: Within 24 hours after surgery
Protamine-related adverse events
Incidence of protamine-related adverse events including hypotension requiring vasopressors, allergic reactions, or anaphylaxis.
Measured: From protamine administration until 24 hours after surgery
Re-exploration for bleeding
Need for surgical re-exploration due to postoperative bleeding.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing elective cardiac surgery with cardiopulmonary bypass will be randomized in a 1:1:1 allocation to receive one of three protamine-to-heparin dosing ratios (1:1, 0.8:1, or 0.75:1) at the termination of cardiopulmonary bypass.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Saadeldeen Farghaly Gadallah, Sohag University
- Investigators
- Asmaa S Farghaly, MD, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477977
- Sponsor's protocol ID
- Soh-Med-26-1-5PD
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Protamine Dose for Reversal of Heparin After Cardiopulmonary Bypass: Is it Safe? Comparative Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT07477977
- Acronym / sponsor ID
- Soh-Med-26-1-5PD
- Conditions
- Open Heart Surgery
- Keywords
- Protamine, Heparin, Activated clotting time, Postoperative bleeding, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protamine sulfate is routinely used to reverse heparin anticoagulation after cardiopulmonary bypass (CPB). The conventional dosing strategy of 1 mg protamine per 100 IU of heparin may result in excess protamine exposure, which has been associated with anticoagulant effects, platelet dysfunction, and hemodynamic instability. Recent evidence suggests that lower protamine doses may provide adequate heparin reversal while reducing potential adverse effects. 
This multicenter, prospective, randomized, double-blind, controlled trial aims to compare three protamine-to-heparin dosing ratios (1:1, 0.8:1, and 0.75:1) in adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. The primary outcome is activated clotting time (ACT) measured 5 minutes after protamine administration. Secondary outcomes include the need for additional protamine administration, protamine-related adverse events, postoperative bleeding, blood product transfusion requirements, and length of intensive care unit stay. 
The results of this study may help determine whether reduced protamine dosing can safely achieve effective heparin reversal while minimizing drug exposure and potential complications after cardiopulmonary bypass. 
Detailed description
Heparin is routinely administered during cardiopulmonary bypass (CPB) to prevent clot formation in the extracorporeal circuit. At the end of CPB, protamine sulfate is used to neutralize the anticoagulant effect of heparin. The conventional protamine dosing strategy is 1 mg of protamine for every 100 IU of the initial heparin dose administered. However, emerging evidence suggests that this standard dosing regimen may result in excessive protamine exposure, which has been associated with adverse effects such as hypotension, pulmonary hypertension, platelet dysfunction, and paradoxical anticoagulation.
Recent studies have suggested that reduced protamine dosing strategies may achieve adequate reversal of heparin anticoagulation while minimizing potential complications associated with protamine administration. However, the optimal protamine-to-heparin ratio remains uncertain.
This randomized clinical study aims to compare different protamine dosing strategies for heparin reversal after cardiopulmonary bypass in adult patients undergoing cardiac surgery. Participants will be randomized to receive one of three protamine dosing regimens based on the initial heparin dose administered during CPB: the conventional 1:1 ratio (1 mg protamine per 100 IU heparin), a reduced dose ratio of 0.8:1, or a further reduced ratio of 0.75:1.
The study will evaluate the effectiveness of these dosing strategies in achieving adequate heparin reversal as measured by activated clotting time (ACT), as well as clinical outcomes including the need for additional protamine administration, postoperative bleeding, transfusion requirements, protamine-related adverse events, re-exploration for bleeding, and duration of intensive care unit stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants undergoing elective cardiac surgery with cardiopulmonary bypass will be randomized in a 1:1:1 allocation to receive one of three protamine-to-heparin dosing ratios (1:1, 0.8:1, or 0.75:1) at the termination of cardiopulmonary bypass.
| Arm | Type | Receives |
|---|---|---|
| Standard Protamine Dose (1:1) | Active comparator | Drug: Protamine sulfateParticipants will receive protamine sulfate at a ratio of 1 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. |
| Reduced Protamine Dose (0.8:1) | Experimental | Drug: Protamine sulfateParticipants will receive protamine sulfate at a ratio of 0.8 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. |
| Reduced Protamine Dose (0.75:1) | Experimental | Drug: Protamine sulfateParticipants will receive protamine sulfate at a ratio of 0.75 mg per 100 IU of the initial heparin dose administered during cardiopulmonary bypass. Protamine will be administered intravenously over 5-10 minutes at the termination of cardiopulmonary bypass for heparin reversal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protamine sulfateAlso: ProtamineProtamine sulfate will be administered intravenously for reversal of heparin anticoagulation after cardiopulmonary bypass. The dose will be calculated according to the randomized study group based on the initial heparin dose administered during cardiopulmonary bypass. | Drug | Reduced Protamine Dose (0.75:1), Reduced Protamine Dose (0.8:1), Standard Protamine Dose (1:1) |
Primary outcome
Post-protamine Activated Clotting Time (ACT)
Time frame: 5 minutes after protamine administration
Activated clotting time measured 5 minutes after completion of protamine administration to assess adequacy of heparin reversal after cardiopulmonary bypass.
5 secondary outcomes
Need for additional protamine administration
Time frame: 5 minutes after initial protamine administration
Postoperative chest tube drainage
Time frame: Within 24 hours after surgery
Blood transfusion requirements
Time frame: Within 24 hours after surgery
Protamine-related adverse events
Time frame: From protamine administration until 24 hours after surgery
Re-exploration for bleeding
Time frame: Within 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asmaa S Farghaly, MD principal investigator
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protamine sulfate in people with Open Heart Surgery, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa S Farghaly, MD (+20 10 20283823, asmaasaad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-protamine Activated Clotting Time (ACT) (time frame: 5 minutes after protamine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.