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A comparison of the use of mini extracorporeal circuits with conventional extracorporeal circuits and with further miniaturized mini extracorporeal circuits in CABG patients.

Completed
Conditions
10007593
1 coronary artery bypass surgery 2 atherosclesis
10011082
Registration Number
NL-OMON33236
Lead Sponsor
Maquet cardiopulmonary
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
150
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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary goal<br /><br><br /><br>The primary goal is to evaluate whether the use of miniaturised systems reduces<br /><br>the need for homologous blood transfusions.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary goal<br /><br><br /><br>The secondary goal is to evaluate whether the use of miniaturised systems<br /><br>reduces the time to extubation post-operatively. To this end an early<br /><br>extubation protocol is used to standardize the extubation process.</p><br>
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