Cardiopulmonary BypassNCT04215588
Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
A study testing Hemostasis Management System Plus and Activated Coagulation Timer System Plus in people with Cardiopulmonary Bypass, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Hemostasis Management System Plus and Activated Coagulation Timer System Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteGreece
- Study dates
- 20 Dec 2019to 30 Sep 2022
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- elective cardiac surgery under cardiopulmonary bypass
Who cannot join
- known blood disorder
- contraindication to heparin administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Hemostasis Management System Plus, Activated Coagulation Timer System Plus
- Keywords
- anticoagulation, cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostasis Management System PlusDevice
Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.
Activated Coagulation Timer System PlusDevice
The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.
| Study group | Role | What they receive |
|---|---|---|
| Individualized heparin and protamine titration | Active comparator | The device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin). Receives: Device: Hemostasis Management System Plus |
| Activated Clotting Time guided heparin and protamine dose | Active comparator | Heparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin) Receives: Device: Activated Coagulation Timer System Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total heparin dose
Heparin dose measured in IU
Measured: operation duration
Total protamine dose
Protamine dose measured in mg
Measured: At the end of the cardiopulmonary bypass
Secondary outcomes (8)
Red Blood Cells transfusion
Red Blood Cells transfusion measured in units
Measured: intraoperatively
Red Blood Cells transfusion
Red Blood Cells transfusion measured in units
Measured: 24 hours after the end of the operation
Fibrinogen concentrate transfusion
Fibrinogen concentrate transfusion measured in g
Measured: intraoperatively
Fibrinogen concentrate transfusion
Fibrinogen concentrate transfusion measured in g
Measured: 24 hours after the end of the operation
Prothrombin Complex Concentrate transfusion
Prothrombin Complex Concentrate transfusion measured in IU
Measured: intraoperatively
Prothrombin Complex Concentrate transfusion
Prothrombin Complex Concentrate transfusion measured in IU
Measured: 24 hours after the end of the operation
Platelets transfusion
Platelet transfusion measured in units
Measured: intraoperatively
Platelets transfusion
Platelet transfusion measured in units
Measured: 24 hours after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start20 Dec 2019
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 134 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
- Eleni Argiriadou, Dr, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215588
- Sponsor's protocol ID
- 7774/16.07.2019
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gkiouliava A, Argiriadou H, Antonitsis P, Goulas A, Papapostolou E, Sarridou D, Karapanagiotidis GT, Anastasiadis K. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study. Perfusion. 2024 Nov;39(8):1595-1604. doi: 10.1177/02676591231204284. Epub 2023 Sep 30.
PubMed 37776194
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT04215588
- Acronym / sponsor ID
- 7774/16.07.2019
- Conditions
- Cardiopulmonary Bypass
- Keywords
- anticoagulation, cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Jan 2020 (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.
During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized heparin and protamine titration | Active comparator | Device: Hemostasis Management System PlusThe device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin). |
| Activated Clotting Time guided heparin and protamine dose | Active comparator | Device: Activated Coagulation Timer System PlusHeparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- elective cardiac surgery under cardiopulmonary bypass
Key exclusion criteria (2 listed)
- known blood disorder
- contraindication to heparin administration
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 |
|---|---|---|
| Hemostasis Management System PlusHemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood. | Device | Individualized heparin and protamine titration |
| Activated Coagulation Timer System PlusThe Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds. | Device | Activated Clotting Time guided heparin and protamine dose |
Primary outcome
Total heparin dose
Time frame: operation duration
Heparin dose measured in IU
Total protamine dose
Time frame: At the end of the cardiopulmonary bypass
Protamine dose measured in mg
8 secondary outcomes
Red Blood Cells transfusion
Time frame: intraoperatively
Red Blood Cells transfusion
Time frame: 24 hours after the end of the operation
Fibrinogen concentrate transfusion
Time frame: intraoperatively
Fibrinogen concentrate transfusion
Time frame: 24 hours after the end of the operation
Prothrombin Complex Concentrate transfusion
Time frame: intraoperatively
Prothrombin Complex Concentrate transfusion
Time frame: 24 hours after the end of the operation
Platelets transfusion
Time frame: intraoperatively
Platelets transfusion
Time frame: 24 hours after the end of the operation
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 3 Jan 2023.
- Derived from this study: PubMed 37776194Gkiouliava A, Argiriadou H, Antonitsis P, Goulas A, Papapostolou E, Sarridou D, Karapanagiotidis GT, Anastasiadis K. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study. Perfusion. 2024 Nov;39(8):1595-1604. doi: 10.1177/02676591231204284. Epub 2023 Sep 30.
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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.
Eleni Argiriadou, Dr study chair
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostasis Management System Plus and Activated Coagulation Timer System Plus in people with Cardiopulmonary Bypass, 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 2 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 3 Jan 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.
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?
Total heparin dose (time frame: operation duration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215588, which also lists 1 linked publication.
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 3 Jan 2023.