NCT03288012

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 19, 2019

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

September 13, 2017

Last Update Submit

July 17, 2019

Conditions

AlloimmunizationSickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sickle cell disease population receiving care in the participating hospitals

You may qualify if:

  • Sickle cell disease
  • Receiving a red blood cell transfusion

You may not qualify if:

  • Previous positive screen for allo-antibodies
  • \>25 red blood cell units in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Academic Medical Center Amsterdam

Amsterdam-Zuidoost, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

HagaZiekenhuis

The Hague, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA analysis and analysis of immune system components involved in alloimmune reactions following erythrocyte transfusion

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Karin Fijnvandraat, MD PhD

CONTACT

+31205123122k.fijnvandraat@sanquin.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 19, 2017

Study Start

September 20, 2017

Primary Completion

June 1, 2021

Study Completion

December 31, 2021

Last Updated

July 19, 2019

Record last verified: 2018-08

Locations

NL(4)