Sickle Cell Disease: Targeting Alloantibody Formation Red... | NCT03288012

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

NCT03288012

Sponsor

Sanquin Research & Blood Bank Divisions

Status

Unknown status

Last Update Posted

Jul 19, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Alloimmunization
Sickle Cell Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2017Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 15, 2017

First Posted Date

Sep 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2019

Last Update Posted Date

Jul 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Sanquin Research & Blood Bank DivisionsOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

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	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Sickle cell disease population receiving care in the participating hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karin Fijnvandraat, MD PhD	Contact	+31205123122		k.fijnvandraat@sanquin.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Center Amsterdam	Recruiting	Amsterdam-Zuidoost			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided