Coagulation; IntravascularPhase 4NCT05426031
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
A Phase 4 study testing Protamine fixed dose and Protamine ratio dose in people with Coagulation; Intravascular, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to compare two different dosing strategies of a drug named protamine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation; Intravascular
- What is being tested?
- Protamine fixed dose and Protamine ratio dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jun 2022to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
- Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.
Who cannot join
- Patients who are under 18 years of age or pregnant.
- Patients undergoing emergency surgery (ASA class E).
- Patients with known coagulation disorders.
- Patients requiring circulatory arrest or deep hypothermia.
- Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
- Patients on pre-operative intravenous unfractionated heparin infusions.
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- Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance.
- Patients who are unable to provide informed consent in the form of a signature.
- History of adverse reaction to protamine.
- Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Hospital
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
About this study
Official title: Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
- Conditions
- Coagulation; Intravascular
- Being tested
- Protamine fixed dose, Protamine ratio dose
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protamine fixed doseDrug
250 mg of protamine intravenously (IV), one time use
Protamine ratio doseDrug
1mg of protamine per 100 units of heparin given intravenously (IV), one time use
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose Protamine group | Experimental | Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Receives: Drug: Protamine fixed dose |
| Ratio Dose Protamine Group | Active comparator | Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Receives: Drug: Protamine ratio dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activated Clotting Time
Activated clotting times will be measured using standard coagulation monitor
Measured: Baseline (before start of surgery)
Activated Clotting Time
Activated clotting times will be measured using standard coagulation monitor
Measured: up to 4 hours (after cardiopulmonary bypass surgery)
Secondary outcomes (3)
Additional Protamine Dosing
Additional protamine dose will be measured in milligrams (mg)
Measured: Up to 4 hours
Chest Tube Output
Measured in milliliters (ml)
Measured: Up to 24 hours
Count of Participants Receiving Red Blood Cell Transfusion
All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start28 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coagulation; IntravascularStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fabbro, University of Miami
- Investigators
- Michael Fabbro, DO, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426031
- Sponsor's protocol ID
- 20220234
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2022
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies
- ClinicalTrials.gov ID
- NCT05426031
- Acronym / sponsor ID
- 20220234
- Conditions
- Coagulation; Intravascular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose Protamine group | Experimental | Drug: Protamine fixed doseParticipants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. |
| Ratio Dose Protamine Group | Active comparator | Drug: Protamine ratio doseParticipants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
- Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.
Key exclusion criteria (10 listed)
- Patients who are under 18 years of age or pregnant.
- Patients undergoing emergency surgery (ASA class E).
- Patients with known coagulation disorders.
- Patients requiring circulatory arrest or deep hypothermia.
- Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
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 |
|---|---|---|
| Protamine fixed dose250 mg of protamine intravenously (IV), one time use | Drug | Fixed Dose Protamine group |
| Protamine ratio dose1mg of protamine per 100 units of heparin given intravenously (IV), one time use | Drug | Ratio Dose Protamine Group |
Primary outcome
Activated Clotting Time
Time frame: Baseline (before start of surgery)
Activated clotting times will be measured using standard coagulation monitor
Activated Clotting Time
Time frame: up to 4 hours (after cardiopulmonary bypass surgery)
Activated clotting times will be measured using standard coagulation monitor
3 secondary outcomes
Additional Protamine Dosing
Time frame: Up to 4 hours
Chest Tube Output
Time frame: Up to 24 hours
Count of Participants Receiving Red Blood Cell Transfusion
Time frame: Up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael Fabbro, DO principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Protamine fixed dose and Protamine ratio dose in people with Coagulation; Intravascular, run by University of Miami at 2 sites in United States.
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 10 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Activated Clotting Time (time frame: Baseline (before start of surgery)). 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?
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 13 Aug 2024.