A comparison of the use of mini extracorporeal circuits with conventional extracorporeal circuits and with further miniaturized mini extracorporeal circuits in CABG patients.
- Conditions
- 100075931 coronary artery bypass surgery 2 atherosclesis10011082
- 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
* 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
* 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
Name Time Method <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
Name Time Method <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>