NCT06254404

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 2, 2024

Last Update Submit

February 2, 2024

Conditions

Protamine DoseProtamine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.

    24 hours

Study Arms (2)

Low dose of Protamine

ACTIVE COMPARATOR
Drug: Low dose protamine

Normal dose of protamine

EXPERIMENTAL
Drug: Low dose protamine

Interventions

Low dose protamineDRUG

Administration of 70% of the normal dose of protamine

Low dose of ProtamineNormal dose of protamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mini-sternotomy aortic valve replacement surgery
  • Major patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Protamines

Intervention Hierarchy (Ancestors)

Nuclear ProteinsProteinsAmino Acids, Peptides, and ProteinsNucleoproteins

Central Study Contacts

Benjamin Javillier, MD

CONTACT

43667180javillier.benjamin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 12, 2024

Study Start

March 15, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02