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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04215588
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 15.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiopulmonary Bypass	Device: Hemostasis Management System Plus; Device: Activated Coagulation Timer System Plus	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Apr 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Total heparin dose [operation duration]

   Heparin dose measured in IU

2. Total protamine dose [At the end of the cardiopulmonary bypass]

   Protamine dose measured in mg

Secondary Outcome Measures

1. Red Blood Cells transfusion [intraoperatively]

   Red Blood Cells transfusion measured in units

2. Red Blood Cells transfusion [24 hours after the end of the operation]

   Red Blood Cells transfusion measured in units

3. Fibrinogen concentrate transfusion [intraoperatively]

   Fibrinogen concentrate transfusion measured in g

4. Fibrinogen concentrate transfusion [24 hours after the end of the operation]

   Fibrinogen concentrate transfusion measured in g

5. Prothrombin Complex Concentrate transfusion [intraoperatively]

   Prothrombin Complex Concentrate transfusion measured in IU

6. Prothrombin Complex Concentrate transfusion [24 hours after the end of the operation]

   Prothrombin Complex Concentrate transfusion measured in IU

7. Platelets transfusion [intraoperatively]

   Platelet transfusion measured in units

8. Platelets transfusion [24 hours after the end of the operation]

   Platelet transfusion measured in units

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent

• elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

• known blood disorder

• contraindication to heparin administration

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Study Chair: Eleni Argiriadou, Dr, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Gkiouliava, PhD candidate, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT04215588
• Other Study ID Numbers: 7774/16.07.2019
• First Posted: Jan 2, 2020
• Last Update Posted: Jan 3, 2020
• Last Verified: Jan 1, 2020

• 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
• Keywords provided by Anna Gkiouliava, PhD candidate, Aristotle University Of Thessaloniki: anticoagulation; cardiopulmonary bypass
• Additional relevant MeSH terms: Hemostatics

Study Results

No Results Posted as of Jan 3, 2020