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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013512

Enrollment

130

Registered

2017-12-04

Start date

2012-08-23

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

I25.1 I35.0

Interventions

Group 1: retrograde autologous priming (RAP) group Group 2: non retrograde autologous priming (Non-RAP) group

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactBritt Hofmann

Universitätsklinikum Halle (Saale)Klinik und Poliklinik für Herzchirurgie

britt.hofmann@uk-halle.de0345 5574990

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026