Objective: Primary objective: Red blood cell aggregation and elongation (deformability) assessed by a laser assisted optical rotational cell analyzer (LORCA) on days 1-3, and within 24 hours after weaning of ECLS. Secondary objectives are red blood…
ID
Source
Brief title
Condition
- Red blood cell disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Red blood cell aggregation and elongation (deformability) assessed by a laser
assisted optical rotational cell analyzer (LORCA) on days 1-3, and within 24
hours after weaning of ECLS.
Secondary outcome
Red blood cell aggregation and elongation (deformability) assessed by a LORCA
on 5, 7, 10, 14, 21 (when appropriate) and within 24 hours after weaning of
ECLS.
Platelet aggregation assessed by the multiple platelet function analyzer
(Multiplate) on days 1, 2, 3, 5, 7, 10, 14, 21 (when appropriate) and within 24
hours after weaning of ECLS.
Von Willebrand-factor, free hemoglobin, reticulocytes, and D-dimers on days 1,
2, 3, 5, 7, 10, 14, 21 (when appropriate) and within 24 hours after weaning of
ECLS.
Background summary
Rationale: Extracorporeal life support (ECLS) is increasingly used in the
intensive care unit and has resulted in improved survival of patients with
critical respiratory or circulatory failure. However the incidence of
hemorrhage and to a lesser extent thromboembolic events during an ECLS
treatment are significant. Hemolysis as an expression of membrane instability
may be preceded by changes in aggregation and deformability of the red blood
cells. Platelet dysfunction can be caused by hemolysis but also due to changes
in aggregation. Systemic inflammatory response might also play a roll. It is
likely that ECLS affects red blood cell and platelet function after its
initiation, the time course of these changes and their clinical relevance is
yet unclear.
Study objective
Objective: Primary objective: Red blood cell aggregation and elongation
(deformability) assessed by a laser assisted optical rotational cell analyzer
(LORCA) on days 1-3, and within 24 hours after weaning of ECLS. Secondary
objectives are red blood cell aggregation and elongation (deformability)
assessed by a LORCA on 5, 7, 10, 14, 21 (when appropriate) and platelet
aggregation assessed by the multiple platelet function analyzer (Multiplate)
and Von Willebrand-factor, free hemoglobin, reticulocytes and D-dimers on days
1, 2, 3, 5, 7, 10, 14, 21 (when appropriate) and within 24 hours after weaning
of ECLS.
Study design
Observational cohort study
Study burden and risks
The risk and burden of an extra 5 ml blood on the study days taken from the
arterial line is deemed in proportion to the potential value of the research.
This study will not be beneficial for the subject. The risk of participation is
considered negligible and the burden minimal because the arterial line is in
place as part of standard care. Patients on ECLS are critically ill patients
and therefore in the majority of the cases incapacitated due to critical
illness and/or sedation.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
All adult patients who start with ECLS in the ICU
Exclusion criteria
- Pregnancy
- Start of ECLS not in the ICU, e.g. after cardiothoracic surgery
- Use of ECLS only for high risk procedure like percutaneous cardiac intervention with planned removal of ECLS within 24 hours.
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 | NL64227.042.17 |