This study will evaluate if the use of a mini extracorporeal circuit is an improvement for the patient. The study investigates how much the use of a mini extracorporeal circuit will change the homologous blood requirements and the magnitude of the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary goal
The primary goal is to evaluate whether the use of miniaturised systems reduces
the need for homologous blood transfusions.
Secondary outcome
Secondary goal
The secondary goal is to evaluate whether the use of miniaturised systems
reduces the time to extubation post-operatively. To this end an early
extubation protocol is used to standardize the extubation process.
Background summary
A conventional extracorporeal circuit, a mini extracorporeal circuit and a
further miniaturized mini extracorporeal circuit are compared in a prospective
randomized clinical.
The oxygenator in the miniaturized mini extracorporeal circuit has been
improved leading to a decrease in the blood contact surface area and priming
volume.
To compare blood usage, biocompatibility and clinical outcome of these three
circuits, one hundred and fifty patients undergoing coronary artery bypass
grafting will be randomly allocated into groups to be perfused with one of
these circuits. In all cases the autotransfusion cell separator will be used to
process the mediastinal shed blood and residual pump blood.
The groups will be compared with each other, in relation with blood cells (PLT,
WBC, RBC), acute phase response (CRP), kidney injury (Urea, Creatinine) cardiac
injury (CPK-MB, Troponin), ischemia (Lactate), and cardiac electrical activity.
Study objective
This study will evaluate if the use of a mini extracorporeal circuit is an
improvement for the patient.
The study investigates how much the use of a mini extracorporeal circuit will
change the homologous blood requirements and the magnitude of the inflammatory
response. We assume that the inflammatory response will be less obvious when we
use the mini extracorporeal circuit by reduction of the blood contact surface
area and the prime volume. Reduction of hemodilution and the inflammatory
response may lead to reduction in the use of homologous blood products and less
organ damage, which also means reduction of costs.
Study design
The study will be performed in a non-academic centre for cardiac surgery, by
means of a clinical prospective study of 150 patients divided in three groups;
a conventional extracorporeal circuit, the mini extracorporeal circuit (MECC)
and a group with a further miniaturised mini extracorporeal circuit (MMECC).
Randomisation of the patients will be performed by the following action: The
day before the surgery an independent person will open an envelope, containing
a treatment form. On the form the date of randomisation and the unique patient
hospital number will be marked. The same day the perfusionist will be informed
for the construction of the appropriate ECC circuit.
Study burden and risks
The possible risk of an incident with the MECC and MMECC circuit is not
significantly different compared with the conventional ECC circuit.
The potential benefit of the use of the MECC and MMECC circuit is the reduction
of homologous blood transfusion with all its risks.
hechingerstrasse 38
72145 hirrlingen
duitsland
hechingerstrasse 38
72145 hirrlingen
duitsland
Listed location countries
Age
Inclusion criteria
* To have the right indication.
* Body surface area between 1.7 and 2.0 m².
* Age 20-80.
* Pre-operative normal sinus rhythm and AV-conduction time.
* Pre- operative haemoglobin > 6.5 mmol/L.
* Patient must be able to give written informed consent
Exclusion criteria
* Transfusion of blood products shorter than seven days before the operation.
* Re- operations
* Coagulation problems due to the use of thrombolytic agents less than 48 hours before the operation.
* Thrombocytopenia (platelet count below 100,000 per ml)
* Patient with hereditary hematological/ coagulation disorders
* Insulin dependent diabetes
* Using corticosteroid medication, use of corticosteroids before the surgery, or during the study period.
* Emergency surgery
* History of atrial fibrillation or other atrial arrhytmias eg (1 ° block, paroxysmal atrial tachycardia, atrial flutter)
*Use of aspirin within 7 days or Plavix within 5 days or other anti platelet agents (including non steroid anti-inflammatory medicaments) within 48 hours.
* Patients who are currently (within the last two months) participating in another clinical trail.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL26418.098.09 |