Obstetrical History and Anti-HLA Antibodies Level

NCT06021925 | Unknown

• 2 other identifiers: APHP2213332021-A01199-32
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic histiocytic intervillositis (CHI) is associated with severe and recurrent obstetrical complications. A link between anti-HLA Antibodies (Ab) and CHI has recently been established. At the Etablissement Français du Sang (EFS), donors who have already given birth once and have high levels of anti-HLA are excluded from donating apheresis platelets and therapeutic plasma to prevent TRALI (Transfusion Related Acute Lung Injury). No studies have examined the obstetrical history of these donors. The question is: is there an association between anti-HLA levels and obstetrical complications?

Conditions

Blood Donors; Anti-HLA Antibody

Keywords

Obstetrical complications; Levels of anti-HLA antibody; Chronic histiocytic intervillositis

Outcome Measures

Primary Outcomes (1)

• To measure the association between the occurrence of obstetrical complications and the level of anti-HLA Ab measured during the screening test performed by the EFS.

  Obstetrical complications are defined as (binomial qualitative variable) : * Preterm delivery \< 37 WA * Fetal death in utero whatever the term * Early or late miscarriage * Early or late pre-eclampsia * Medical termination of pregnancy * Intrauterine growth retardation \<3rd percentile

  2 months

Secondary Outcomes (3)

• Type and precocity of obstetrical complication (multinomial qualitative variable)

  2 months

• Measure the association between the type and precocity of obstetrical complications according to the type of anti-HLA Ab (class I and/or class II), when these Ab are found during the screening test performed by the EFS

  2 months

• Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors.

  2 months

Study Arms (1)

Blood donors tested for anti-HLA Antibody

Blood donors tested for anti-HLA Antibody between 2010 and 2020 as part of TRALI prevention program.

Other: Obstetrical history; Other: Anti-HLA Antibody tests

Interventions

Obstetrical history OTHER

Selection of donors by EFS retrospectively on the basis of inclusion criteria. Information note sent by e-mail, non-opposition as well as a questionnaire to be completed online to obtain data on obstetrical history.

Blood donors tested for anti-HLA Antibody

Anti-HLA Antibody tests OTHER

Analyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation.

Blood donors tested for anti-HLA Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Blood donors who were screened for anti-HLA Ab between 2010 and 2020 as part of TRALI prevention at the EFS Poitiers site histocompatibility laboratory.

You may qualify if:

• Female blood donors who have been tested for anti-HLA antibodies in the context of TRALI prevention between 2010 and 2020 at EFS Nouvelle Aquitaine \[The donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well\]
• Women who have already given birth at least once (non-nulliparous women)
• Women who have not expressed their opposition at the time of donation to participating in a research project and to be contacted

You may not qualify if:

• None \[Donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well\]

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Etablissement Français du Sang (Nouvelle Aquitaine): collaborator

Study Sites (1)

Etablissement Français du Sang Nouvelle Aquitaine

Bordeaux, 33075, France

RECRUITING

Study Officials

• Xavier LAFARGE, Doctor

  Etablissement Français du Sang (Nouvelle Aquitaine)

  PRINCIPAL INVESTIGATOR

• Alexandra BENACHI, Professor

  APHP, Antoine Béclère Hospital, CLAMART, France

  STUDY DIRECTOR

Central Study Contacts

Xavier LAFARGE, Doctor

CONTACT

05 56 90 83 93; xavier.lafarge@efs.sante.fr

Isabelle JOLLET

CONTACT

05 49 61 57 27; isabelle.jollet@efs.sante.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 1, 2023
• Study Start: December 13, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)