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Protamine fixed dose for Intravascular Coagulation

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

Study Summary

This trial will compare two different protamine doses to see which is more effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in activated clotting time
Secondary outcome measures
Additional protamine dosing
Chest tube output
Units of red blood cells transfused

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
897 Previous Clinical Trials
409,130 Total Patients Enrolled
Michael Fabbro, DOPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are physicians actively seeking out participants for this experiment?

"Affirmative. Per the data on clinicaltrials.gov, this trial is presently seeking participants to enroll; it was inaugurated on 28th June 2022 and has been revised at least once since then (28th July). 130 volunteers are required from two sites of recruitment."

Answered by AI

How efficacious is Protamine fixed dose in safeguarding individuals?

"There is significant evidence backing the use of Protamine fixed dose, which earns it a rating of 3. This Phase 4 treatment has already been approved by regulatory bodies."

Answered by AI

What is the current participant capacity for this research project?

"Affirmative. Clinicaltrials.gov reveals that the investigation is currently enrolling participants, which began on June 28th 2022 and was recently amended on July 28th 2022. This research requires 130 patients to be recruited from 2 sites."

Answered by AI
~47 spots leftby Mar 2025