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New treatment option for Open Heart Surgery
Official title Dose for Reversal of Heparin After Cardiopulmonary Bypass
ClinicalTrials.gov ID: NCT07477977
What this study is testing
What is Protamine sulfate?
Protamine sulfate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for open heart surgery.
Also referred to as Protamine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sohag, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sohag, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.