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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215588
• Other study ID #: 7774/16.07.2019
• Status: Completed
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Informed consent

• elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

• known blood disorder

• contraindication to heparin administration

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

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

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total heparin dose	Heparin dose measured in IU	operation duration
Primary	Total protamine dose	Protamine dose measured in mg	At the end of the cardiopulmonary bypass
Secondary	Red Blood Cells transfusion	Red Blood Cells transfusion measured in units	intraoperatively
Secondary	Red Blood Cells transfusion	Red Blood Cells transfusion measured in units	24 hours after the end of the operation
Secondary	Fibrinogen concentrate transfusion	Fibrinogen concentrate transfusion measured in g	intraoperatively
Secondary	Fibrinogen concentrate transfusion	Fibrinogen concentrate transfusion measured in g	24 hours after the end of the operation
Secondary	Prothrombin Complex Concentrate transfusion	Prothrombin Complex Concentrate transfusion measured in IU	intraoperatively
Secondary	Prothrombin Complex Concentrate transfusion	Prothrombin Complex Concentrate transfusion measured in IU	24 hours after the end of the operation
Secondary	Platelets transfusion	Platelet transfusion measured in units	intraoperatively
Secondary	Platelets transfusion	Platelet transfusion measured in units	24 hours after the end of the operation