Anticoagulation Management in Complex Cardiac Surgery

PHASE4CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

February 20, 2023

Conditions
Extracorporeal Circulation
Interventions
OTHER

Activated Clotting Time measurements combined with heparin concentration monitoring

In the HC group, the initial heparin dose is calculated using the HepCon HMS Plus . Except for ACT, heparin concentration is measured to maintain target heparin levels during CPB. The protamine dose for reversal is computed based on actual measured heparin levels using the device. ACT is also performed in all instances.

OTHER

Activated Clotting Time

The target ACT for procedures other than Coronary Artery Bypass Grafting (CABG) is 400s when Minimally Invasive Extracorporeal Circulation is used. A bolus of 300 International Units(IU)/kg heparin are administered to reach this target and initiate cardiopulmonary bypass (CPB). Repeated ACT measurements guide further heparin dose to maintain adequate anticoagulation. Then, at the end of the CPB, 0.75 mg of protamine are administered for every 100IU of the initial heparin bolus.

Trial Locations (1)

54124

AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki

All Listed Sponsors
lead

Aristotle University Of Thessaloniki

OTHER

NCT05944107 - Anticoagulation Management in Complex Cardiac Surgery | Biotech Hunter | Biotech Hunter