Protamine DoseNCT06254404
Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
A study testing Low dose protamine in people with Protamine Dose and Protamine Adverse Reaction, run by University of Liege.
Trial summary
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protamine Dose, Protamine Adverse Reaction
- What is being tested?
- Low dose protamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 1 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini-sternotomy aortic valve replacement surgery
- Major patients
Who cannot join
- Hypersensitivity to protamine
- Coagulation Abnormalities
- Heparin allergy
- Pregnant women
- Jehovah's Witnesses
Trial locations and contacts
No sites are listed yet.
About this study
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.
- Conditions
- Protamine Dose, Protamine Adverse Reaction
- Being tested
- Low dose protamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose protamineDrug
Administration of 70% of the normal dose of protamine
| Study group | Role | What they receive |
|---|---|---|
| Low dose of Protamine | Active comparator | Not described Receives: Drug: Low dose protamine |
| Normal dose of protamine | Experimental | Not described Receives: Drug: Low dose protamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protamine DoseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, MD, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254404
- Sponsor's protocol ID
- LowProt
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT06254404
- Acronym / sponsor ID
- LowProt
- Conditions
- Protamine Dose, Protamine Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 Feb 2024 (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.
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose of Protamine | Active comparator | Drug: Low dose protamine |
| Normal dose of protamine | Experimental | Drug: Low dose protamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini-sternotomy aortic valve replacement surgery
- Major patients
Key exclusion criteria (5 listed)
- Hypersensitivity to protamine
- Coagulation Abnormalities
- Heparin allergy
- Pregnant women
- Jehovah's Witnesses
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 |
|---|---|---|
| Low dose protamineAdministration of 70% of the normal dose of protamine | Drug | Low dose of Protamine, Normal dose of protamine |
Primary outcome
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose protamine in people with Protamine Dose and Protamine Adverse Reaction, run by University of Liege.
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 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (43667180 ext. +32, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50. (time frame: 24 hours). 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 12 Feb 2024.