This in vitro study aims at investigating a possible relationship between plasma free haemoglobin, catheter diameter (i.e. resistance), pump rotational speed, pump heating and pump flow using freshly donated human blood in a mock circulation of an…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het betreft geen directe aandoening. Het betreft een in vitro onderzoek gebruik makend van donorbloed. De donoren zijn gezonde vrijwilligers.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
in vitro plasma free haemoglobin
Secondary outcome
-in vitro circuit temperature
-in vitro circuit blood flow rate
-in vitro circuit pressure
Background summary
Extracorporeal life support (ELS) has proven a successful technique to provide
cardiopulmonary assistance in acute heart and/or lung failure using supporting
blood flows of 3-6 l/min. Adapted towards a low-flow application using
supporting blood flows of approximately 0.5-1.0 l/min and small catheters, ELS
can be used for extracorporeal CO2 removal in patients suffering from
exacerbation of chronic obstructive pulmonary disease.
The use of relatively small catheters, however, opposes a challenge for the
blood pump. Small bore catheters induce an increased blood flow resistance. To
compensate for such hydraulic resistance, pump speeds must be increased.
Increasing pump speed while pump flow remains relatively low, however, can lead
to pump heating. Such pump heating as well as high pump rotational speeds may
cause haemolysis. Haemolysis with resultant increased levels of plasma free
haemoglobin leads to kidney damage, which in patients undergoing cardiac
surgery has shown to affect clinical outcome.
Study objective
This in vitro study aims at investigating a possible relationship between
plasma free haemoglobin, catheter diameter (i.e. resistance), pump rotational
speed, pump heating and pump flow using freshly donated human blood in a mock
circulation of an extracorporeal life support for CO2 removal.
Study design
In this prospective study an in vitro setup will be filled with donated fresh
human blood from healthy volunteers willing to donate approximately 200 ml.
Blood will be drawn by a physician and collected in a blood donation bag
containing citrate for anticoagulation.
Intervention
vena punction and whole blood donation
Study burden and risks
There are no direct benefits for the healthy volunteers willing do donate whole
blood. Blood is drawn by a vena punction by an experienced physician. Blood is
donated under standard transfusion laboratory conditions, i.e. lying on a bed,
with vital parameter monitoring, and fluid supply during and after donation.
Moreover, since the donated volume (approximately 200 ml) amounts to
approximately 4% of the human blood volume (5 litres), no hemodynamic
consequences are to be expected. Standard risks are pain, fainting and
infection.
P. Debyelaan 25
HX 6229
NL
P. Debyelaan 25
HX 6229
NL
Listed location countries
Age
Inclusion criteria
healthy volunteer
Exclusion criteria
-volunteers known with anaemia or those not feeling well
-volunteer that has taken part in this study or donated blood during the past 7 days
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 | NL49743.068.14 |