To evaluate the effect of age of transfused erythrocytes on expression of *eat me* signals on erythrocytes in several critically ill patient populations (septic and non-septic patients) and to correlate these signals with parameters of impaired…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in the expression of PS on erythrocytes before and after transfusion of
erythrocytes
Secondary outcome
- Expression of erythrocyte CD44, CD47, CD55, CD59, Band 3, MFG-E8, Gas6, IgG,
levels of heme and complement in blood
- Expression of platelet CD62P, CD62E, CD63, and levels of microparticles
sCD40L, sP-selectin, and thrombocyte-leukocyte complexes in blood and NBALF
- Levels of hemoglobin, erythrocytes, platelets, leucocytes and
leucodifferentiation in blood
- Levels of fibrinogen, APTT, PTT and D-dimers in blood (to calculate DIC score)
- Levels of ADAMTS13, active VWF and VWF multimer size in blood (experimental
markers of DIC)
- Levels of TAT-complexes, pro-thrombin fragment F1+2,factor VIIa, tissue
factor in blood (markers of coagulation)
- Levels of tissue type plasminogen activator inhibitor-1 (PAI-1) and
plasmin-a2-antiplasmin complexes (PAP-complex) in blood (markers of
fibrinolysis)
- Sublingual microcirculatory density and perfusion velocity, as visualized
with SDF
- Tissue oxygenation, as measured with NIRS
- Onset of TRALI
- Time on mechanical ventilation
- Duration of ICU stay
- Duration of hospital stay
- 28 day mortality
Background summary
Blood transfusion in critically ill patients contributes to mortality, while
the yield remains questioned. Observational studies have shown a correlation
between the age of transfused erythrocytes and adverse outcome. 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 evaluate the effect of age of transfused erythrocytes on expression of *eat
me* signals on erythrocytes in several critically ill patient populations
(septic and non-septic patients) and to correlate these signals with parameters
of impaired microcirculation.
Study design
A single centre randomized controlled trial
Intervention
The transfusion of erythrocytes of < 8 days old, instead of the standard
transfusion with erythrocytes that have been stored for 2-35 days.
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. Either patients receive erythrocytes according to standard care, or
they receive solely fresh erythrocytes, which has a potential beneficial
effect. Patients who pose difficulties in securing blood products (rare blood
groups) or who are difficult to match, will not be included. Therefore,
participation in this study has a potential benefit, while risk of
participation related to the intervention is unaltered. 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). The
additive burden of a non-directed bronchoalveolar mini-lavage is small because
it is a frequently performed technique in mechanically ventilated patients in
the ICU.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients who will receive their first erythrocyte transfusion on the ICU to correct for anemia
Exclusion criteria
- Patients who have not given informed consent
- Patients who pose difficulties in securing blood products (e.g. rare blood groups)
- Patients who are actively bleeding or are suspected for active bleeding (when a transfusion is given with the intention to treat bleeding according to the treating physician)
- Patients who receive more than 1 unit of red blood cells in the transfusion episode
- Patients who need a blood transfusion when there*s no fresh blood available
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34692.018.11 |