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Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
Phase 4
Waitlist Available
Led By Michael Fabbro, DO
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to compare two different dosing strategies of protamine, a drug used to stop the blood-thinning effects of heparin in patients who have undergone surgery. Protamine is the only clinically approved antidote to heparin, but it has shown adverse effects and ineffectiveness against certain heparin-related medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activated Clotting Time
Secondary study objectives
Additional Protamine Dosing
Chest Tube Output
Count of Participants Receiving Red Blood Cell Transfusion
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fixed Dose Protamine groupExperimental Treatment1 Intervention
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.
Group II: Ratio Dose Protamine GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Protamine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
950 Previous Clinical Trials
428,263 Total Patients Enrolled
Michael Fabbro, DOPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
50 Total Patients Enrolled