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Efficacy of a novel low priming cardiopulmonary bypass system in adult cardiac surgery: a randomized controlled trial

Efficacy of a novel low priming cardiopulmonary bypass system in adult cardiac surgery: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050488
Enrollment
Unknown
Registered
2021-08-28
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

None listed

Interventions

Experimental group:Receive FUWAI-SAVE system for cardiopulmonary bypass
Control group:Receive conventional cardiopulmonary bypass system

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Open heart surgery under cardiopulmonary bypass caused by various etiologies; 2. Aged >= 18 years; 3. The blood transfusion risk stratification score (Appendix 2) is 61-80 points; 4. Subjects signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials within 1 month, and has been assessed to have a greater impact on this research; 2. Weight < 40kg; 3. Those who have a history of allergies to extracorporeal circulation pipelines and blood recovery equipment in the past; 4. Heart transplantation or combined heart-lung transplantation; 5. Perform emergency surgery; 6. Perform a second thoracotomy; 7. Perform hybrid surgery; 8. Perform major vascular surgery requiring deep hypothermic cardiopulmonary bypass; 9. Patients with mental illness or medical history, drug addicts, AIDS, syphilis, hepatitis B, hepatitis C virus positive patients; 10. Those with severe anemia, infection, tumor, active bleeding, severe liver, lung, and kidney disease; 11. Other circumstances judged by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
red blood cell transfusion;

Secondary

MeasureTime frame
platelet transfusions;fresh frozen plasma infusion;hemoglobin;C reactive protein;anticoagulation tests;neutrophil extracellular trap;angiopoietin;inflammatory factors;the incidence of major complications during pericardial circulation;inhospital mortality;mechanical ventilation time;ICU time;hospital stay;chest drainage;ICU cost;inhospital cost;

Countries

China

Contacts

Public ContactJi Bingyang
jibingyang@fuwai.com+86 13801251767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026