Extracorporeal CirculationPhase 4NCT05944107
Anticoagulation Management in Complex Cardiac Surgery
A Phase 4 study testing Activated Clotting Time measurements combined with heparin concentration monitoring and Activated Clotting Time in people with Extracorporeal Circulation, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation
- What is being tested?
- Activated Clotting Time measurements combined with heparin concentration monitoring and Activated Clotting Time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to 20 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective procedures
- cardiac surgery, except for Coronary Artery Bypass Grafting
- Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation
Who cannot join
- known allergy to heparin or protamine
- hematological disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, 54124
About this study
Official title: 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.
- Conditions
- Extracorporeal Circulation
- Being tested
- Activated Clotting Time measurements combined with heparin concentration monitoring, Activated Clotting Time
- Keywords
- anticoagulation, cardiopulmonary bypass, heparin, titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Activated Clotting Time measurements combined with heparin concentration monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heparin dose
Heparin dose, IU
Measured: Bolus dose before cardiopulmonary bypass
Heparin dose
Heparin dose, IU
Measured: Total dose after cardiopulmonary bypass
Protamine dose
Protamine dose, mg
Measured: Total dose after cardiopulmonary bypass
Secondary outcomes (3)
Platelet count
Platelet count per mm^3
Measured: Immediately after surgery
Platelet count
Platelet count per mm^3
Measured: 24 hours after surgery
Platelet count
Platelet count per mm^3
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Gkiouliava, Aristotle University Of Thessaloniki
- Investigators
- Helena Argiriadou, Dr, Study director, AHEPA University Hospital, Aristotole University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944107
- Sponsor's protocol ID
- 3432
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05944107
- Acronym / sponsor ID
- 3432
- Conditions
- Extracorporeal Circulation
- Keywords
- anticoagulation, cardiopulmonary bypass, heparin, titration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated Clotting Time (ACT) | Active comparator | Other: Activated Clotting TimeIn 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 |
| Heparin Concentration (HC) | Active comparator | Other: Activated Clotting Time measurements combined with heparin concentration monitoringIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective procedures
- cardiac surgery, except for Coronary Artery Bypass Grafting
- Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation
Key exclusion criteria (2 listed)
- known allergy to heparin or protamine
- hematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Clotting Time measurements combined with heparin concentration monitoringIn 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 | Heparin Concentration (HC) |
| Activated Clotting TimeThe 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. | Other | Activated Clotting Time (ACT) |
Primary outcome
Heparin dose
Time frame: Bolus dose before cardiopulmonary bypass
Heparin dose, IU
Heparin dose
Time frame: Total dose after cardiopulmonary bypass
Heparin dose, IU
Protamine dose
Time frame: Total dose after cardiopulmonary bypass
Protamine dose, mg
3 secondary outcomes
Platelet count
Time frame: Immediately after surgery
Platelet count
Time frame: 24 hours after surgery
Platelet count
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Argiriadou, Dr study director
AHEPA University Hospital, Aristotole University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Activated Clotting Time measurements combined with heparin concentration monitoring and Activated Clotting Time in people with Extracorporeal Circulation, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heparin dose (time frame: Bolus dose before cardiopulmonary bypass). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.