Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33236
Enrollment
150
Registered
2009-07-07
Start date
2009-10-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1 coronary artery bypass surgery 2 atherosclesis

Interventions

None listed

Sponsors

Maquet cardiopulmonary
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Primary goal The primary goal is to evaluate whether the use of miniaturised systems reduces the need for homologous blood transfusions.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)