Validation of accuracy of TEG® in critically ill children in the PICU.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
bloedstolling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Establishing intra- and inter observer variability of TEG® parameters (clotting
time (r), clot kinetics (k and alfa angle) and clot strength (maximum
amplitude)) in 0,5 ml kaolin activated whole blood of critically ill children.
Secondary outcome
Determination of TEG® manipulation duration and time to results of the
different TEG® parameters.
Background summary
Thromboelastography is a method to evaluate the viscoelastic properties during
blood clot formation and clot lysis. The Tromboelastograph system (TEG®) is a
point of care system using whole blood. TEG® is sensitive to all the
interacting cellular and plasmatic components while conventional clotting tests
measure plasma hemostasis only. Perioperative application of TEG® resulted in
reduction of hemostatic products and tranfusions. Application of TEG® in
postoperative and/or intensive care hemostasis management in critically ill
children in the Pediatric Iintensive Care Unit (PICU) might improve diagnostic
yield and thereby allowing more targeted therapy for complex hemostatic
problems. Validation of TEG in this context using a sample volume of 0,5 ml
whole blood has never been done.
Study objective
Validation of accuracy of TEG® in critically ill children in the PICU.
Study design
Non invasive prospective observational study.
Study burden and risks
Additional blood sampling from an arterial or central venous line will be
combined with ordered blood samples for standard care implicating no additional
risk or burden related to manipulation of the arterial or central venous line.
Each TEG® sample is 0,5 ml whole blood and to compare two samples 1,0 ml of
whole blood is needed. One participant can participate more than once but the
total amount of blood drawn will be limited to 3 to 5 ml (depending on weight
of the patient). In this patient group a total extra blood loss for sampling of
1 to 5 ml is regarded minimal compared to a mean weekly blood loss associated
with regular blood sampling in pediatric intensive care. So the risk for
participants related to additional blood loss due to sampling can be considered
negligible. Because the hemostatic system in children is distinctly different
from that in adults and the influence of critical illness on hemostasis is
highly variable validation of TEG® can only be done in this patient group.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
•Arterial or central venous line in situ. Insertion of arterial or venous line must be indicated on clinical basis as a part of normal critical care management. No lines will be inserted just for study purposes.
•Written informed consent
Exclusion criteria
•Dysfunctional arterial or central venous line - no free flowing sampling of blood possible
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL17681.042.07 |