Anticoagulation Management in Complex Cardiac Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05944107

Enrollment

Registered

2023-07-13

Start date

2021-01-01

Completion date

2023-02-20

Last updated

2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Circulation

Keywords

anticoagulation, cardiopulmonary bypass, heparin, titration

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.

Interventions

OTHERActivated 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.

OTHERActivated 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Heparin dose	Bolus dose before cardiopulmonary bypass	Heparin dose, IU
Protamine dose	Total dose after cardiopulmonary bypass	Protamine dose, mg

Secondary

Measure	Time frame	Description
Platelet count	Immediately after surgery	Platelet count per mm\^3

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026