NCT04595617

Brief Summary

This project aim to correlate risk factors (genetic, therapeutic and socio-demographic factors) to anti-αIIbβ3 antibodies formation following blood products transfusion (platelets or packed red cells) or pregnancy in a national cohort of GT patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2.5 years

First QC Date

August 17, 2020

Last Update Submit

March 6, 2024

Conditions

Glanzmann Thrombasthenia

Keywords

Glanzmann thrombastheniaanti-GPIIb-IIIa immunizationMAIPAPlatelet transfusionsRecombinant activated factor VII

Outcome Measures

Primary Outcomes (2)

  • Characterization of change of an anti-αIIbβ3 immunization

    Characterization of change of an anti-αIIbβ3 immunization will be assessed with Indirect MoAb-specific immobilization of platelet antigens (MAIPA)

    From inclusion to 18 months visit

  • Number of patients with positive anti-αIIbβ3 antibodies in relation to risk factors

    Risk factors could be subtype of GT, year of birth, ITGA2B or ITGB3 gene mutation

    From inclusion to 18 months visit

Secondary Outcomes (3)

  • Determination of the prevalence of anti-αIIbβ3 antibodies in a regional cohort of GT patients

    From inclusion to 18 months visit

  • Description of the kinetic of an anti-αIIbβ3 immunization following blood transfusion

    At 7-10 days and 1 month (+/-2 weeks) after each blood transfusion

  • Determination of the mechanism of anti-αIIbβ3 antibodies blocking integrin function by determining the capacity of anti-αIIbβ3 antibodies to impair fibrinogen binding

    through study completion, an average of 2 years

Study Arms (1)

Patients with diagnosis of Glanzmann Thrombastenia (GT)

EXPERIMENTAL

Antibodies screening will be systematically realized every six months (+/- 2 weeks) and after each last blood transfusion at 7-10 days and one month (+/- 2 weeks), during a period of 18 months

Biological: Antibodies screening

Interventions

Antibodies screeningBIOLOGICAL

All included GT patients will be enrolled from different national centres during a 6 months period. Antibodies screening will be systematically realized every six months (+/- 2 weeks) and after each last blood transfusion at 7-10 days and one month (+/- 2 weeks), during a period of 18 months.

Patients with diagnosis of Glanzmann Thrombastenia (GT)

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with a clear diagnosis of Glanzmann Thrombastenia (GT), whatever the subtype of disease.
  • Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

  • Current treatment that may interfere with anti-αIIbβ3 antibodies detection, such as intravenous immunoglobulins within the previous month.
  • Psychiatric, social or behavioral condition judged to be non-compatible with the respect of the protocol, including good observance of treatment and compliance to follow-up.
  • Adult protected by the law.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Bordeaux - Hôpital Haut-Lévêque

Bordeaux, France

Location

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

Location

Hôpital Bicêtre, APHP

Le Kremlin-Bicêtre, France

Location

Hôpital la Timone, APHM

Marseille, France

Location

CHU Nîmes

Nîmes, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Thrombasthenia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mathieu FIORE

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

October 20, 2020

Study Start

January 6, 2021

Primary Completion

July 6, 2023

Study Completion

July 6, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)