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

NCT ID: NCT06254404

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-10-01

Brief Summary

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

Detailed Description

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Conditions

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Protamine Dose Protamine Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Low dose of Protamine

Group Type ACTIVE_COMPARATOR

Low dose protamine

Intervention Type DRUG

Administration of 70% of the normal dose of protamine

Normal dose of protamine

Group Type EXPERIMENTAL

Low dose protamine

Intervention Type DRUG

Administration of 70% of the normal dose of protamine

Interventions

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Low dose protamine

Administration of 70% of the normal dose of protamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mini-sternotomy aortic valve replacement surgery
* Major patients

Exclusion Criteria

* Hypersensitivity to protamine
* Coagulation Abnormalities
* Heparin allergy
* Pregnant women
* Jehovah's Witnesses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Javillier, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Benjamin Javillier, MD

Role: CONTACT

43667180 ext. +32

Other Identifiers

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LowProt

Identifier Type: -

Identifier Source: org_study_id

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