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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Individualized heparin and protamine titration

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).

Group Type ACTIVE_COMPARATOR

Hemostasis Management System Plus

Intervention Type DEVICE

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.

Activated Clotting Time guided heparin and protamine dose

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)

Group Type ACTIVE_COMPARATOR

Activated Coagulation Timer System Plus

Intervention Type DEVICE

The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.

Interventions

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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.

Intervention Type DEVICE