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

• Conditions: Alloimmunization; Sickle Cell Disease

• Registration Number: NCT03288012
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Start: 2017-09-20
• Status Verified: 2018-08
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	6 months	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

Trial Locations

Locations (4)

Academic Medical Center Amsterdam; 🇳🇱 Amsterdam-Zuidoost, Netherlands

HagaZiekenhuis; 🇳🇱 Den Haag, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands