Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery

Protamine Adverse Reaction Clinical Trial

Official title:

Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254404
• Other study ID #: LowProt
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: University of Liege
• Contact: Benjamin Javillier, MD
• Phone: 43667180
• Email: javillier.benjamin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mini-sternotomy aortic valve replacement surgery
• Major patients

Exclusion Criteria:

• Hypersensitivity to protamine
• Coagulation Abnormalities
• Heparin allergy
• Pregnant women
• Jehovah's Witnesses

Related Conditions & MeSH terms

• Protamine Adverse Reaction

Intervention

Drug:
• Low dose protamine
Administration of 70% of the normal dose of protamine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.		24 hours