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Anticoagulation Management in Complex Cardiac Surgery

NCT05944107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-07-14

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Helena Argiriadou, Dr · AHEPA University Hospital, Aristotole University of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-12-31
Completion
2023-02-20

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944107 on ClinicalTrials.gov