Dose for Reversal of Heparin After Cardiopulmonary Bypass

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSohag University

About this 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. 

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Protamine sulfate

Treatment groups

195 Participants
are divided into 3 treatment groups

Sponsors and collaborators