Anticoagulation Management in Complex Cardiac Surgery

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Extracorporeal Circulation

Treatments: Other: Activated Clotting Time measurements combined with heparin concentration monitoring; Other: Activated Clotting Time

Study type: Interventional

Funder types: Other

Identifiers

NCT05944107

3432

Details and patient eligibility

About

The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:

• initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.
• protamine dose among groups.

Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective procedures
• cardiac surgery, except for Coronary Artery Bypass Grafting
• Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

Exclusion criteria

• known allergy to heparin or protamine
• hematological disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Activated Clotting Time (ACT)

Active Comparator group

Description:

In this group, only ACT measurements and fixed doses of heparin and protamine are administered. ACT is measured using the ACT Plus device (Medtronic, MN, USA). Heparin formulation administered is HEPARIN/LEO INJ.SOL 25000IU/5ML. Protamine formulation administered is PROTAMINE SULPHATE/LEO PHARMA 10mg/ml

Treatment:

Other: Activated Clotting Time

Heparin Concentration (HC)

Active Comparator group

Description:

In this group, the Hepcon HMS Plus (Medtronic, MN, USA) is used to perform heparin concentration calculations and test each patient's individual response to heparin. Specifically tests performed were: * Heparin Dose Response test * Heparin Assay test

Treatment:

Other: Activated Clotting Time measurements combined with heparin concentration monitoring