Back to resultsContribution of PRF in CDH in Children With Prothetic Patch Closure (HECODIAP)
Primary Purpose
Congenital Diaphragmatic Hernias
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Biological functionalization of the prosthetic materials by PRF
Sponsored by
About this trial
This is an interventional other trial for Congenital Diaphragmatic Hernias
Eligibility Criteria
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
Sites / Locations
- Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Adult Healthy Volunteers
Neonates
Arm Description
Outcomes
Primary Outcome Measures
Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.
Analysis of cell colonization after cell culture.
Secondary Outcome Measures
Full Information
NCT ID
NCT03861182
First Posted
January 24, 2019
Last Updated
January 14, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03861182
Brief Title
Contribution of PRF in CDH in Children With Prothetic Patch Closure
Acronym
HECODIAP
Official Title
Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of staff
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernias
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult Healthy Volunteers
Arm Type
Other
Arm Title
Neonates
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Biological functionalization of the prosthetic materials by PRF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.
Description
Analysis of cell colonization after cell culture.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67 091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Contribution of PRF in CDH in Children With Prothetic Patch Closure
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