NCT04215588

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

Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DEVICE	Hemostasis Management System Plus	Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.
DEVICE	Activated Coagulation Timer System Plus	The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.

Timeline

• Start date: 2019-12-20
• Primary completion: 2022-09-01
• Completion: 2022-09-30
• First posted: 2020-01-02
• Last updated: 2023-01-03

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated device study