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Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

NCT05426031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-08-13

Study results available
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Summary

The purpose of this study is to compare two different dosing strategies of a drug named protamine.

Conditions

  • Coagulation; Intravascular

Interventions

DRUG

Protamine fixed dose

250 mg of protamine intravenously (IV), one time use

DRUG

Protamine ratio dose

1mg of protamine per 100 units of heparin given intravenously (IV), one time use

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Michael Fabbro, DO · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-06-01
Completion
2023-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426031 on ClinicalTrials.gov