Blood DonorsOBS-HLANCT06021925
Obstetrical History and Anti-HLA Antibodies Level
An observational study of Blood Donors and Anti-HLA Antibody, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Donors, Anti-HLA Antibody
- What is being tested?
- Obstetrical history and Anti-HLA Antibody tests
- How many people
- 6,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2023to 13 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Etablissement Français du Sang Nouvelle Aquitaine
Bordeaux, 33075
Xavier LAFARGE, 05 56 90 83 93, xavier.lafarge@efs.sante.fr
Isabelle JOLLET, 05 49 61 57 27, isabelle.jollet@efs.sante.fr
About this study
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?
Read the detailed description
Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of around 5 in 10,000 pregnancies. It is defined by major infiltration of the intervillous cavity by CD68+ maternal histiocytes, associated with fibrin deposition on the villous surface.
CHI is associated with severe obstetrical complications and a very high recurrence rate, estimated at between 70% and 100%. These complications include early and late miscarriage, fetal death, severe growth retardation in surviving fetuses, and premature delivery. The survival rate reported in the literature varies between 30% and 50%.
Anti-HLA antibodies are present in 54% of pregnant women at the end of pregnancy, and their rate increases towards the end of pregnancy. The presence of HLA antibodies also increases with the number of pregnancies, and is found in up to 74% of cases after more than 2 deliveries.
The research question concerns the existence of a statistically significant association between the presence of high levels of anti-HLA antibodies and the occurrence of one or more obstetric complications.
- Conditions
- Blood Donors, Anti-HLA Antibody
- Being tested
- Obstetrical history, Anti-HLA Antibody tests
- Keywords
- Obstetrical complications, Levels of anti-HLA antibody, Chronic histiocytic intervillositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetrical historyOther
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.
Anti-HLA Antibody testsOther
Analyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation.
| Study group | Role | What they receive |
|---|---|---|
| Blood donors tested for anti-HLA Antibody | Blood donors tested for anti-HLA Antibody between 2010 and 2020 as part of TRALI prevention program. Receives: Other: Obstetrical history; Other: Anti-HLA Antibody tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (3)
Type and precocity of obstetrical complication (multinomial qualitative variable)
- Preterm deliveries < 37 WA and ≥ 34 WA
- Premature deliveries < 34 WA
- Fetal death in utero regardless of term
- Late miscarriage < 22 WA and ≥ 14 WA
- Early miscarriage < 14 WA
- Late pre-eclampsia > 37 WA and ≥ 34 WA
- Early pre-eclampsia < 34 WA
- Medical termination of pregnancy
- Intrauterine growth retardation <3rd percentile
Measured: 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
- Preterm deliveries < 37 WA and ≥ 34 WA
- Premature deliveries < 34 WA
- Fetal death in utero regardless of term
- Late miscarriage < 22 WA and ≥ 14 WA
- Early miscarriage < 14 WA
- Late pre-eclampsia > 37 WA and ≥ 34 WA
- Early pre-eclampsia < 34 WA
- Medical termination of pregnancy
- Intrauterine growth retardation <3rd percentile
Measured: 2 months
Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors.
Anti-HLA antibody rate (median)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start13 Dec 2023
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang (Nouvelle Aquitaine)
- Responsible party
- Sponsor
- Investigators
- Xavier LAFARGE, Doctor, Principal investigator, Etablissement Français du Sang (Nouvelle Aquitaine)Alexandra BENACHI, Professor, Study director, APHP, Antoine Béclère Hospital, CLAMART, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021925
- Sponsor's protocol ID
- APHP221333
- Other IDs
- 2021-A01199-32
- Acronym
- OBS-HLA
- Status last verified
- Jan 2024
- First submitted
- 25 Aug 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical History and Anti-HLA Antibodies Level
- ClinicalTrials.gov ID
- NCT06021925
- Acronym / sponsor ID
- OBS-HLA / APHP221333
- Conditions
- Blood Donors, Anti-HLA Antibody
- Keywords
- Obstetrical complications, Levels of anti-HLA antibody, Chronic histiocytic intervillositis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang (Nouvelle Aquitaine)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of around 5 in 10,000 pregnancies. It is defined by major infiltration of the intervillous cavity by CD68+ maternal histiocytes, associated with fibrin deposition on the villous surface.
CHI is associated with severe obstetrical complications and a very high recurrence rate, estimated at between 70% and 100%. These complications include early and late miscarriage, fetal death, severe growth retardation in surviving fetuses, and premature delivery. The survival rate reported in the literature varies between 30% and 50%.
Anti-HLA antibodies are present in 54% of pregnant women at the end of pregnancy, and their rate increases towards the end of pregnancy. The presence of HLA antibodies also increases with the number of pregnancies, and is found in up to 74% of cases after more than 2 deliveries.
The research question concerns the existence of a statistically significant association between the presence of high levels of anti-HLA antibodies and the occurrence of one or more obstetric complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood donors tested for anti-HLA Antibody | – | Other: Obstetrical history, Other: Anti-HLA Antibody testsBlood donors tested for anti-HLA Antibody between 2010 and 2020 as part of TRALI prevention program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetrical historySelection 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. | Other | Blood donors tested for anti-HLA Antibody |
| Anti-HLA Antibody testsAnalyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation. | Other | Blood donors tested for anti-HLA Antibody |
Primary outcome
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.
Time frame: 2 months
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
3 secondary outcomes
Type and precocity of obstetrical complication (multinomial qualitative variable)
Time frame: 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
Time frame: 2 months
Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier LAFARGE, Doctor principal investigator
Etablissement Français du Sang (Nouvelle Aquitaine)
Alexandra BENACHI, Professor study director
APHP, Antoine Béclère Hospital, CLAMART, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donors and Anti-HLA Antibody, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier LAFARGE, Doctor (05 56 90 83 93, xavier.lafarge@efs.sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.