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

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

Sponsors

Lead Sponsor: Sanquin Research & Blood Bank Divisions

Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University
HagaZiekenhuis
Erasmus Medical Center

Source 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.

Overall Status Recruiting
Start Date September 20, 2017
Completion Date December 31, 2021
Primary Completion Date June 1, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
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
Enrollment 150
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Karin Fijnvandraat, MD PhD

Phone: +31205123122

Email: [email protected]

Location
Facility: Status: Contact:
Academic Medical Center Amsterdam | Amsterdam-Zuidoost, Netherlands Recruiting Karin Fijnvandraat, PhD +31 02 5123122 [email protected]
HagaZiekenhuis | Den Haag, Netherlands Not yet recruiting Jean Louis Kerkhoffs, PhD Jean-Louis Kerkhoffs, PhD Principal Investigator
Radboudumc | Nijmegen, Netherlands Recruiting S Schols, MD 0031243618800
Erasmus MC | Rotterdam, Netherlands Recruiting Marjon Cnossen, PhD Marjon Cnossen, PhD Principal Investigator
Location Countries

Netherlands

Verification Date

August 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym STARRING
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov