Anticoagulation Management in Complex Cardiac Surgery

July 12, 2023 updated by: Anna Gkiouliava, Aristotle University Of Thessaloniki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • AHEPA University Hospital, Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heparin dose
Time Frame: Bolus dose before cardiopulmonary bypass
Heparin dose, IU
Bolus dose before cardiopulmonary bypass
Heparin dose
Time Frame: Total dose after cardiopulmonary bypass
Heparin dose, IU
Total dose after cardiopulmonary bypass
Protamine dose
Time Frame: Total dose after cardiopulmonary bypass
Protamine dose, mg
Total dose after cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet count
Time Frame: Immediately after surgery
Platelet count per mm^3
Immediately after surgery
Platelet count
Time Frame: 24 hours after surgery
Platelet count per mm^3
24 hours after surgery
Platelet count
Time Frame: 48 hours after surgery
Platelet count per mm^3
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

June 24, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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