RBC clearance

Identification of removal signals on donor erythrocytes after transfusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25526

Enrollment

Registered

2014-09-11

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problem studied: To try and identify the so called 'removal signals' on donor erythrocytes after transfusion to ensure a longer RBC survival and higher quality of the transfused erythrocytes due to removal of those cells prior to a blood transfusion. Het identificeren van "verwijdersignalen" op donor erytrocyten zodat in de toekomst de kwaliteit/overlevingsduur van de erytrocyten wordt vergroot na depletie van deze cellen voorafgaand aan een bloedtransfusie. Keywords: Storage lesion RBC

Interventions

Venipuncture

Eligibility

Inclusion criteria

Inclusion criteria: - A low WPSS 0-1 with transfusion requirement who are not eligible for intensive treatment or Clinical trials (i.e. elderly MDS patients); - A life expectancy of a minimum of 6 months; - Age > 18 years; - Full knowledge of the Dutch language.

Exclusion criteria

Exclusion criteria: - If no minor antigen mismatch can be made; - No informed consent (IC); - Patients under the age of eighteen; - Patients that have a medical history with an autoimmune haemolytic anemia (AIHA) or patients that will develop an AIHA during the study; - Patients with an enlarged spleen; - Pregnancy; - Patients with intensive MDS treatment.

Design outcomes

Primary

Measure	Time frame
Changes in all possible “removal signals” on the outer layer of the RBC membrane compared to short versus long stored RBC, like upregulation of phosphatidylserine (PS), conformation of CD47, and auto-antibody binding. We would also like to study the binding of PS-bridging proteins such as lactadherin, Von Willebrand Factor (vWF) and Protein S, as well as the CD47-binding protein thrombospondin-1.	—

Measure

Time frame

Changes in all possible “removal signals” on the outer layer of the RBC membrane compared to short versus long stored RBC, like upregulation of phosphatidylserine (PS), conformation of CD47, and auto-antibody binding. We would also like to study the binding of PS-bridging proteins such as lactadherin, Von Willebrand Factor (vWF) and Protein S, as well as the CD47-binding protein thrombospondin-1.

—

Secondary

Measure	Time frame
Standard of care parameters: Hemoglobin, platelets, WBC and differentiation, ferritin, CRP Additional measured parameters for study: Other parameters on infection (CRP), iron status (Fe, hemopexin, hepcidin, NTBI), cytokines (TNFa, IL-1/IL-6, IL8), complement (C3 and C4) and antigens in complement biology (CD35, CD55, CD59, and factor H), antigens for adhesive capacities: CD44, CD147, ICAM-4, L-selectin for activation of monocyte, sICAM-1/sVCAM1 for endothelial activation and monocyte markers (CD14, CD11b), will also be studied.	—

Measure

Time frame

Standard of care parameters: Hemoglobin, platelets, WBC and differentiation, ferritin, CRP Additional measured parameters for study: Other parameters on infection (CRP), iron status (Fe, hemopexin, hepcidin, NTBI), cytokines (TNFa, IL-1/IL-6, IL8), complement (C3 and C4) and antigens in complement biology (CD35, CD55, CD59, and factor H), antigens for adhesive capacities: CD44, CD147, ICAM-4, L-selectin for activation of monocyte, sICAM-1/sVCAM1 for endothelial activation and monocyte markers (CD14, CD11b), will also be studied.

—

Contacts

Public ContactD. Back, de

d.deback@sanquin.n020-5123000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)