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

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass
• Intervention / Treatment: Device: Hemostasis Management System Plus; Device: Activated Coagulation Timer System Plus

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Aristotle University Of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent
• elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

• known blood disorder
• contraindication to heparin administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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.
Active Comparator: 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)	Device: Activated Coagulation Timer System Plus; The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total heparin dose	Heparin dose measured in IU	operation duration
Total protamine dose	Protamine dose measured in mg	At the end of the cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red Blood Cells transfusion	Red Blood Cells transfusion measured in units	intraoperatively
Red Blood Cells transfusion	Red Blood Cells transfusion measured in units	24 hours after the end of the operation
Fibrinogen concentrate transfusion	Fibrinogen concentrate transfusion measured in g	intraoperatively
Fibrinogen concentrate transfusion	Fibrinogen concentrate transfusion measured in g	24 hours after the end of the operation
Prothrombin Complex Concentrate transfusion	Prothrombin Complex Concentrate transfusion measured in IU	intraoperatively
Prothrombin Complex Concentrate transfusion	Prothrombin Complex Concentrate transfusion measured in IU	24 hours after the end of the operation
Platelets transfusion	Platelet transfusion measured in units	intraoperatively
Platelets transfusion	Platelet transfusion measured in units	24 hours after the end of the operation

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Chair: Eleni Argiriadou, Dr, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; anticoagulation
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: 7774/16.07.2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes