NCT05426031

Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass

Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Coagulation; Intravascular

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-06-21
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study