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

February 2, 2024 updated by: Benjamin Javillier, MD, University of Liege
Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mini-sternotomy aortic valve replacement surgery
  • Major patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose of Protamine
Drug: Low dose protamine
Administration of 70% of the normal dose of protamine
Experimental: Normal dose of protamine
Drug: Low dose protamine
Administration of 70% of the normal dose of protamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Minimum effective dose of protamine after extracorporeal circulation. A bottom-up and top-down method will define CP 50.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LowProt

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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