Influence of retrograde autologous priming (RAP) on the safety and efficacy of cardiopulmonary bypass (CPB) and transfusion requirements

Not Applicable

• Conditions: I25.1; I35.0; Atherosclerotic heart disease; Aortic (valve) stenosis

• Registration Number: DRKS00013512
• Lead Sponsor: niversitätsklinikum Halle (Saale)Klinik und Poliklinik für Herzchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-10-21
• Study Start: 2017-12-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

1. Patient is older than 18 years.
2. Patient has coronary heart disease or aortic valve defect and is a suitable candidate for cardiopulmonary bypass (CPB) surgery.
3. Patient has been informed about the study and has given his written consent.

Exclusion Criteria

1. Ejection fraction = 20%
2. Re-operation
3. Acute endocarditis
4. Acute myocardial infarction within 24 hours before the procedure, calculated on the onset of symptoms.
5. Known pre-operative presence of intracardiac thrombi
6. Stenosis of an internal carotid artery > 70%
7. Dialysis
8. Malignant disease or immunological diseases
9. Taking Marcumar, preoperative continuous heparin infusion or known coagulopathy
10. Thrombocytopenia (<100 Gpt/l)
11. Patients after pre-operative own blood donation
12. Taking steroids
13. Participation in another study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the need for intraoperative blood transfusion through the use of the RAP bag for retrograde autologous priming compared to conventional priming in patients undergoing cardiac surgery for the treatment of coronary heart disease or aortic valve defect.

Secondary Outcome Measures

Name	Time	Method
SAFETY<br>• Absence of complications related to the priming technique used<br>• Bleeding and reoperation for bleeding (excluding patients with a surgical cause for reoperation)<br>• Post-operative atrial fibrillation (defined as any arrhythmia requiring treatment and / or irregular rhythm and missing P wave identified by ECG)<br><br>EFFECTIVENESS<br>• Transfusion needs<br>• Reduction of the filling volume of the perfusion circuit<br>• Inflammatory reaction (standard parameters)<br>• Intubation time<br>• Duration of stay in the intensive care unit<br>• Length of hospital stay