Improve the quality of red blood cells used for cardiopulmonary bypass for neonates and infants with a bodyweight smaller then 10 Kg.
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hemoglobin, hematocrit, platelet count, potassium, sodium, chlorine, lactate,
free hemoglobin and blood gasses will be measured by standard protocol.
Secondary outcome
Ventricular function assessment will be measured by routine intra-operative
Tran esophageal echocardiography and by thermo dilution. Hospitalization and
ventilation period will be noted.
Background summary
Every unit of irradiated red blood cells contents an increased level of lactate
and potassium. The concentration is depended of the storage time.
It is possible to wash irradiated red blood cells before using it. The result
is a unit of red blood cells without lactate and potassium in a pH neutral
solution
Study objective
Improve the quality of red blood cells used for cardiopulmonary bypass for
neonates and infants with a bodyweight smaller then 10 Kg.
Study design
Patients with a body weight smaller then 20 Kg will be randomly allocated in
one of two groups: unwashed red blood cells and pre-washed red blood cells by
using the method of randomly permuted blocks of 10.
Intervention
Donor red blood cells (pre-washed group) will be washed by a cellsaver before
using it in the prime of the cardiopulmonary bypass circuit.
Study burden and risks
Washing red blood cells is not related with extra risk for patient treatment it
supposed to be an improvement of quality.
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
Nederland
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
Nederland
Listed location countries
Age
Inclusion criteria
Neonates and infants with a bodyweight of < 20 kg
Elective heartsurgery
Exclusion criteria
Hepatic insufficienty
Renal insufficiency
Procedures with deep hypothermic circulatory arrest
Procedures with a prolonged low flow technique
Infants with a body weight > =20 kg
Emergency procedures
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 | NL29013.000.09 |