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NCT03288012 Clinical Trial

Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Sickle Cell Disease Clinical Trial

— STARRING  

Official title:
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03288012
Other study ID # NL60834.018.17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2017
Est. completion date December 31, 2021

Study information
Verified date August 2018
Source Sanquin Research & Blood Bank Divisions
Contact Karin Fijnvandraat, MD PhD
Phone +31205123122
Email k.fijnvandraat@sanquin.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.

Description:

The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients.

Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion).

At each time point specific markers of the immune system will be measured.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Sickle cell disease

- Receiving a red blood cell transfusion

Exclusion Criteria:

- Previous positive screen for allo-antibodies

- >25 red blood cell units in the past

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Academic Medical Center Amsterdam Amsterdam-Zuidoost
Netherlands HagaZiekenhuis Den Haag
Netherlands Radboudumc Nijmegen
Netherlands Erasmus MC Rotterdam

Sponsors (5)
Lead Sponsor Collaborator
Sanquin Research & Blood Bank Divisions Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, HagaZiekenhuis, Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls 6 months
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