Contribution of PRF in CDH in Children With Prothetic Patch Closure

NCT ID: NCT03861182

Last Updated: 2021-01-19

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2019-12-10

Brief Summary

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Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Detailed Description

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Conditions

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Congenital Diaphragmatic Hernias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adult Healthy Volunteers

Group Type OTHER

Biological functionalization of the prosthetic materials by PRF

Intervention Type BIOLOGICAL

The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Neonates

Group Type OTHER

Biological functionalization of the prosthetic materials by PRF

Intervention Type BIOLOGICAL

The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Interventions

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Biological functionalization of the prosthetic materials by PRF

The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Adult Healthy Volunteers :

\- Over 18 years of age

Neonates:

* Aged between 1h of life and 28 days of life
* Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight
* Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg
* For whom a blood sample was prescribed as part of their routine care

Exclusion Criteria

Adult Healthy Volunteers :

* Systemic inflammatory disease
* Transient inflammatory state
* Any drug that modifies the coagulation cascade during the 48h preceding the sampling

Neonates:

* Risk of anemia \< 7g/DL
* Current anticoagulant treatment
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7067

Identifier Type: -

Identifier Source: org_study_id

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