AlloimmunizationSTARRINGNCT03288012
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
An observational study of Alloimmunization and Sickle Cell Disease, run by Sanquin Research & Blood Bank Divisions at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alloimmunization, Sickle Cell Disease
- How many people
- 150 participants
- Where
- 4 sitesNetherlands
- Study dates
- 20 Sep 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sickle cell disease population receiving care in the participating hospitals
Who may be able to join
- Sickle cell disease
- Receiving a red blood cell transfusion
Who cannot join
- Previous positive screen for allo-antibodies
- >25 red blood cell units in the past
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Recruiting
Academic Medical Center Amsterdam
Amsterdam-Zuidoost
Karin Fijnvandraat, PhD, +31 02 5123122, c.j.fijnvandraat@amc.nl
- Recruiting
Radboudumc
Nijmegen
S Schols, MD, 0031243618800
- Recruiting
Erasmus MC
Rotterdam
Marjon Cnossen, PhD
Marjon Cnossen, PhD
- Not yet recruiting
HagaZiekenhuis
The Hague
Jean Louis Kerkhoffs, PhD
Jean-Louis Kerkhoffs, PhD
About this study
The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.
Read the 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.
- Conditions
- Alloimmunization, Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start20 Sep 2017
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlloimmunizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, HagaZiekenhuis, Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288012
- Sponsor's protocol ID
- NL60834.018.17
- Acronym
- STARRING
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
- ClinicalTrials.gov ID
- NCT03288012
- Acronym / sponsor ID
- STARRING / NL60834.018.17
- Conditions
- Alloimmunization, Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, HagaZiekenhuis, Erasmus Medical Center
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sickle cell disease population receiving care in the participating hospitals
Key inclusion criteria (2 listed)
- Sickle cell disease
- Receiving a red blood cell transfusion
Key exclusion criteria (2 listed)
- Previous positive screen for allo-antibodies
- >25 red blood cell units in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
Related trials for Alloimmunization
RecruitingObservational study
Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease
Sickle Cell Disease
Not yet recruiting
Prenatal Blood Typing With Next Generation Sequencing (NGS) - an Implementation Study in HDFN (PREFAB)
Red Blood Cell Alloimmunization in Pregnancy, HDFN
RecruitingPhase 1/2
Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
Kidney Failure, Chronic, Kidney Transplantation
RecruitingObservational study
Hemophilia A Research Program
Hemophilia A, Hemophilia A, Severe
Not yet recruiting
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion
Lung Graft Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alloimmunization and Sickle Cell Disease, run by Sanquin Research & Blood Bank Divisions at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karin Fijnvandraat, MD PhD (+31205123122, k.fijnvandraat@sanquin.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.