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OpenTrials
Completed

NCT Number: NCT05944107

Anticoagulation Management in Complex Cardiac Surgery

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.

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Key information

Conditions

Extracorporeal Circulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AHEPA University Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activated Clotting Time measurements combined with heparin concentration monitoring

Other

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

Other

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.

Primary outcomes

  1. Heparin dose

    Time frame: Bolus dose before cardiopulmonary bypass

    Heparin dose, IU

  2. Heparin dose

    Time frame: Total dose after cardiopulmonary bypass

    Heparin dose, IU

  3. Protamine dose

    Time frame: Total dose after cardiopulmonary bypass

    Protamine dose, mg

Secondary outcomes

  1. Platelet count

    Time frame: Immediately after surgery

    Platelet count per mm^3

  2. Platelet count

    Time frame: 24 hours after surgery

    Platelet count per mm^3

  3. Platelet count

    Time frame: 48 hours after surgery

    Platelet count per mm^3

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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