Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2021-01-01
2023-02-20
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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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
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.
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* cardiac surgery, except for Coronary Artery Bypass Grafting
* Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation
Exclusion Criteria
* hematological disease
18 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Anna Gkiouliava
Principal Investigator
Principal Investigators
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Helena Argiriadou, Dr
Role: STUDY_DIRECTOR
AHEPA University Hospital, Aristotole University of Thessaloniki
Locations
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AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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3432
Identifier Type: -
Identifier Source: org_study_id
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