NCT05944107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

June 24, 2023

Last Update Submit

July 12, 2023

Conditions

Extracorporeal Circulation

Keywords

anticoagulationcardiopulmonary bypassheparintitration

Outcome Measures

Primary Outcomes (3)

  • Heparin dose

    Heparin dose, IU

    Bolus dose before cardiopulmonary bypass

  • Heparin dose

    Heparin dose, IU

    Total dose after cardiopulmonary bypass

  • Protamine dose

    Protamine dose, mg

    Total dose after cardiopulmonary bypass

Secondary Outcomes (3)

  • Platelet count

    Immediately after surgery

  • Platelet count

    24 hours after surgery

  • Platelet count

    48 hours after surgery

Study Arms (2)

Activated Clotting Time (ACT)

ACTIVE COMPARATOR

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

Heparin Concentration (HC)

ACTIVE COMPARATOR

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

Interventions

Activated Clotting Time measurements combined with heparin concentration monitoringOTHER

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.

Heparin Concentration (HC)
Activated Clotting TimeOTHER

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.

Activated Clotting Time (ACT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective procedures
  • cardiac surgery, except for Coronary Artery Bypass Grafting
  • Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

You may not qualify if:

  • known allergy to heparin or protamine
  • hematological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

Study Officials

  • Helena Argiriadou, Dr

    AHEPA University Hospital, Aristotole University of Thessaloniki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 13, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

February 20, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

GR(1)