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Completed

NCT Number: NCT04215588

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

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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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aristotle University of Thessaloniki

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • elective cardiac surgery under cardiopulmonary bypass

Exclusion criteria

  • known blood disorder
  • contraindication to heparin administration

Treatment and study plan

Hemostasis Management System Plus

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 Coagulation Timer System Plus

Device

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

Primary outcomes

  1. Total heparin dose

    Time frame: operation duration

    Heparin dose measured in IU

  2. Total protamine dose

    Time frame: At the end of the cardiopulmonary bypass

    Protamine dose measured in mg

Secondary outcomes

  1. Red Blood Cells transfusion

    Time frame: intraoperatively

    Red Blood Cells transfusion measured in units

  2. Red Blood Cells transfusion

    Time frame: 24 hours after the end of the operation

    Red Blood Cells transfusion measured in units

  3. Fibrinogen concentrate transfusion

    Time frame: intraoperatively

    Fibrinogen concentrate transfusion measured in g

  4. Fibrinogen concentrate transfusion

    Time frame: 24 hours after the end of the operation

    Fibrinogen concentrate transfusion measured in g

  5. Prothrombin Complex Concentrate transfusion

    Time frame: intraoperatively

    Prothrombin Complex Concentrate transfusion measured in IU

  6. Prothrombin Complex Concentrate transfusion

    Time frame: 24 hours after the end of the operation

    Prothrombin Complex Concentrate transfusion measured in IU

  7. Platelets transfusion

    Time frame: intraoperatively

    Platelet transfusion measured in units

  8. Platelets transfusion

    Time frame: 24 hours after the end of the operation

    Platelet transfusion measured in units

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 2, 2020
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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