Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation

Not Applicable

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Device: Hemostasis Management System Plus; Device: Activated Coagulation Timer System Plus

• Registration Number: NCT04215588
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-20
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-29
• Study First Posted: 2020-01-02
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Informed consent
• elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria

• known blood disorder
• contraindication to heparin administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized heparin and protamine titration	Hemostasis Management System Plus	The device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin).
Activated Clotting Time guided heparin and protamine dose	Activated Coagulation Timer System Plus	Heparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin)

Primary Outcome Measures

Name	Time	Method
Total heparin dose	operation duration	Heparin dose measured in IU
Total protamine dose	At the end of the cardiopulmonary bypass	Protamine dose measured in mg

Secondary Outcome Measures

Name	Time	Method
Red Blood Cells transfusion	24 hours after the end of the operation	Red Blood Cells transfusion measured in units
Fibrinogen concentrate transfusion	24 hours after the end of the operation	Fibrinogen concentrate transfusion measured in g
Prothrombin Complex Concentrate transfusion	24 hours after the end of the operation	Prothrombin Complex Concentrate transfusion measured in IU
Platelets transfusion	24 hours after the end of the operation	Platelet transfusion measured in units

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece