Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04156906
Status:
RECRUITING
Last Update Posted:
2023-08-07
First Post:
2019-11-06
Brief Title:
RHD Genotype Matched Red Cells for Anti-D
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
RH Genotype Matched Red Cells for Patients With Sickle Cell Disease and Anti-D
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to evaluate the feasibility and safety of providing RH genotype matched D Red Blood Cells RBCs to chronically transfused patients with sickle cell disease SCD who type D but have formed anti-D and are currently transfused with D- RBC Red Blood Cell units
Detailed Description:
Red blood cell transfusion remains a critical therapy for patients with sickle cell disease SCD A major problem is the high rate of alloimmunization antibody formation against transfused red cells that occurs in patients with SCD Recent studies performed by Investigators and others demonstrate RH genetic variants in patients and donors is a major risk factor leading to Rh alloimmunization Anti-D formation in D patients occurs frequently and once identified providing D- cells for all subsequent transfusions can be challenging These anti-D antibodies in D patients suggest exposure to different or variant D protein on donor cells Investigators will test whether transfusion of patients with anti-D with RHD genotyped matched red cells is feasible safe and can decrease D- donor unit demand
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL147879-01 | NIH | None | httpsreporternihgovquickSearchR01HL147879-01 |