Anticoagulation Management in Complex Cardiac Surgery

Extracorporeal Circulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05944107
• Other study ID #: 3432
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: February 20, 2023

Study information

• Verified date: July 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 20, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Circulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	AHEPA University Hospital, 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	Heparin dose	Heparin dose, IU	Bolus dose before cardiopulmonary bypass
Primary	Heparin dose	Heparin dose, IU	Total dose after cardiopulmonary bypass
Primary	Protamine dose	Protamine dose, mg	Total dose after cardiopulmonary bypass
Secondary	Platelet count	Platelet count per mm^3	Immediately after surgery
Secondary	Platelet count	Platelet count per mm^3	24 hours after surgery
Secondary	Platelet count	Platelet count per mm^3	48 hours after surgery