Anticoagulation Management in Complex Cardiac Surgery

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT05944107

Collaborator

(none)

Enrollment

Location

Arms

25.6

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Circulation	Other: Activated Clotting Time measurements combined with heparin concentration monitoring Other: Activated Clotting Time	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Activated Clotting Time (ACT) 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	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.
Active Comparator: Heparin Concentration (HC) 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	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.

Arm

Intervention/Treatment

Active Comparator: Activated Clotting Time (ACT)

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

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.

Active Comparator: Heparin Concentration (HC)

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

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.

Outcome Measures

Primary Outcome Measures

Heparin dose [Bolus dose before cardiopulmonary bypass]
Heparin dose, IU
Heparin dose [Total dose after cardiopulmonary bypass]
Heparin dose, IU
Protamine dose [Total dose after cardiopulmonary bypass]
Protamine dose, mg

Secondary Outcome Measures

Platelet count [Immediately after surgery]
Platelet count per mm^3
Platelet count [24 hours after surgery]
Platelet count per mm^3
Platelet count [48 hours after surgery]
Platelet count per mm^3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AHEPA University Hospital, Aristotle University of Thessaloniki	Thessaloniki		Greece	54124

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Investigators

Study Director: Helena Argiriadou, Dr, AHEPA University Hospital, Aristotole University of Thessaloniki

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Gkiouliava, Principal Investigator, Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT05944107

Other Study ID Numbers:

3432

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anna Gkiouliava, Principal Investigator, Aristotle University Of Thessaloniki

anticoagulation

cardiopulmonary bypass

heparin

titration

Additional relevant MeSH terms:

Heparin

Study Results

No Results Posted as of Jul 14, 2023