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

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Cardiopulmonary Bypass

Treatments: Device: Activated Coagulation Timer System Plus; Device: Hemostasis Management System Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT04215588

7774/16.07.2019

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• elective cardiac surgery under cardiopulmonary bypass

Exclusion criteria

• known blood disorder
• contraindication to heparin administration

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

Individualized heparin and protamine titration

Active Comparator group

Description:

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).

Treatment:

Device: Hemostasis Management System Plus

Activated Clotting Time guided heparin and protamine dose

Active Comparator group

Description:

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)

Treatment:

Device: Activated Coagulation Timer System Plus