To determine the effect of transfusion on the expression of PS in critically ill patients with and without inflammation.
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in the expression of PS on erythrocytes before and after RBC transfusion
and the influence of an inflammatory state in the receiver.
Secondary outcome
* Clearance rate of erythrocytes
- expression of clearance markers, other than PS
* markers of immune cell and endothelial cell activation and adhesion
* complete blood count
* Levels of fibrinogen, APTT, PTT and D-dimers in blood (to calculate DIC score)
* markers of inflammatory host respons
* Sublingual microcirculatory density and perfusion velocity, as visualized
with SDF
* Tissue oxygenation, as measured with NIRS
* VO2 (oxygen uptake), DO2 (oxygen delivery), O2ER (oxygen extraction ratio)
* Time on mechanical ventilation
* Duration of ICU stay
* Duration of hospital stay
* 28 day mortality
* DNA staining on residual red blood cell material,
* Red blood cell deformability, activation status and cell-binding ability
Background summary
Blood transfusion in critically ill patients contributes to mortality, while
the yield remains questioned. Mechanisms of adverse effects are unknown, but
may include accelerated clearance from the circulation and vascular adherence
shortly after transfusion, thereby impeding microcirculation, tissue
oxygenation and heme-metabolism. Clearance of erythrocytes may be mediated by
expression of *eat me* signals, such as phosphatidylserine (PS). Expression of
PS *eat me* signals is enhanced during storage of erythrocytes in vitro. Also,
sepsis was shown to increase PS eat me* signal expression, contributing to
clearance in an ex vivo design. The finding that the presence of sepsis and
increased storage time negatively influences the effect of erythrocyte
transfusion at the tissue level, may alter transfusion or blood banking
practice.
Study objective
To determine the effect of transfusion on the expression of PS in critically
ill patients with and without inflammation.
Study design
A single center prospective cohort study
Study burden and risks
Detrimental effects of transfusion are thought to be more extensive in
critically ill patients. Therefore, a study in this specific population is
necessary. Patients who pose difficulties in securing blood products (rare
blood groups) or who are difficult to match, will not be included. Prior to
transfusion stored RBCs will be biotinylated (vitamine B8) to allow their
indentification by flow cytometry. Preperation will be done under sterile
conditions. Although in a healthy volunteer study 1 out of 8 subjects developed
a transient positive test for antibody to biotinylated RBCs, at 11 months post
transfusion antibodies to biotinylated RBCs has disappeared. Biotin labeling
has no effect on RBC survival. Thus, biotinylation of RBCs is considered safe.
Risk of participation related to analytic methods is considered to be very
small, because assessments of the microcirculation and echocardiography are
non-invasive and blood samples are drawn from an arterial catheter that is
already in place as part of the standard patient care (there will be no burden
from extra venapunctures).
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
Patients who will receive an erythrocyte transfusion in the ICU (to correct for anemia) and are not suspected of an active bleeding.
Exclusion criteria
* Patients who have not given informed consent
* Patients who pose difficulties in securing blood products (e.g. rare blood groups)
* Patients who receive more than 1 unit of RBCs in 1 transfusion episode
* No arterial catheter in situ
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61833.018.17 |
| OMON | NL-OMON27009 |