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

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ClinicalTrials.gov Identifier: NCT03288012
Recruitment Status : Unknown
Verified August 2018 by Sanquin Research & Blood Bank Divisions.
Recruitment status was:  Recruiting
First Posted : September 19, 2017
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University Medical Center
HagaZiekenhuis
Erasmus Medical Center
Information provided by (Responsible Party):
Sanquin Research & Blood Bank Divisions

Tracking Information
First Submitted Date September 13, 2017
First Posted Date September 19, 2017
Last Update Posted Date July 19, 2019
Actual Study Start Date September 20, 2017
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2017)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
Official Title Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples for DNA analysis and analysis of immune system components involved in alloimmune reactions following erythrocyte transfusion
Sampling Method Probability Sample
Study Population Sickle cell disease population receiving care in the participating hospitals
Condition
  • Alloimmunization
  • Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 15, 2017)		 150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03288012
Other Study ID Numbers NL60834.018.17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Sanquin Research & Blood Bank Divisions
Original Responsible Party Same as current
Current Study Sponsor Sanquin Research & Blood Bank Divisions
Original Study Sponsor Same as current
Collaborators
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Radboud University Medical Center
  • HagaZiekenhuis
  • Erasmus Medical Center
Investigators Not Provided
PRS Account Sanquin Research & Blood Bank Divisions
Verification Date August 2018