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

July 17, 2019 updated by: Sanquin Research & Blood Bank Divisions
The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam-Zuidoost, Netherlands
        • Recruiting
        • Academic Medical Center Amsterdam
        • Contact:
      • Den Haag, Netherlands
        • Not yet recruiting
        • HagaZiekenhuis
        • Contact:
          • Jean Louis Kerkhoffs, PhD
        • Principal Investigator:
          • Jean-Louis Kerkhoffs, PhD
      • Nijmegen, Netherlands
        • Recruiting
        • Radboudumc
        • Contact:
          • S Schols, MD
          • Phone Number: 0031243618800
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
        • Contact:
          • Marjon Cnossen, PhD
        • Principal Investigator:
          • Marjon Cnossen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sickle cell disease population receiving care in the participating hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanquin Research & Blood Bank Divisions

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL60834.018.17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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