Patients undergoing cardiovascular surgery Cardiovascular Surgery
Conditions
Interventions
Consent will be obtained and provisionally registered before the day of surgery. Final registration/allocation will be conducted during CPB, and the study product will be transfused from the time of w
Operative Blood Salvage
Blood salvage, Cell salvage, Autologous blood transfusion
Sponsors
Tsukinaga Akito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age >=40 years old 2)Patients who will undergo elective cardiovascular surgery with CPB and are at risk of high bleeding defined by any of a)History of previous cardiac surgery with median sternotomy (re-do) b)Root surgery (Ross procedure, AVR with root enlargement, or root replacement), ascending aorta or arch allograft replacement c)Valvular surgery of two or more valves, excluding tricuspid annuloplasty d)Coronary artery bypass surgery combined with valvular surgery, excluding tricuspid annuloplasty 3)Patients undergoing allogenic red blood cell products during CPB
Exclusion criteria
Exclusion criteria: 1) Descending aorta or thoracic and abdominal allograft replacement, heart transplantation, ventricular assist device implantation, or pulmonary valve replacement 2) Extremely high risk of bleeding, defined as either a preoperative platelet count of = 2 prior cardiovascular surgeries via median sternotomy. 3) Antiplatelet agent or anticoagulant use that does not comply with the following withdrawal periods: 4) Active bacterial or viral infections 5) Pregnant or breastfeeding 6) Rh(D) antigen negativity 7) Irregular RBC antibody positivity 8) Patients judged inappropriate for participation by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total drainage output after 12 hours of admission to the ICU | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) RBC transfusion volume during surgery and for 12 hours from the end of surgery (2) Prevalence of re-thoracotomy within 48 hours from the end of surgery (3) Prevalence of postoperative chest tube blood loss of >= 1000 mL within 12 hours from the end of surgery The safety outcomes are as follows: (4) Prevalence of any of the following infections: surgical site infection, mediastinitis, urinary tract infection, respiratory infection, central nervous system infection, gastrointestinal system infection, skin and soft tissue infection, or other infection (5) Prevalence of gross hematuria upon ICU admission (6) Prevalence of acute kidney injury within 7 days after surgery, defined in accordance with the Kidney Disease Improving Global Outcomes criteria The exploratory outcomes are as follows: (7) Results of blood viscoelastic testing, prothrombin time, activated partial thromboplastin time, and platelet count (8) Transfusion volume during surgery and for 12 hours from the end of surgery (FFP without cryoprecipitate / cryoprecipitate / platelet concentrate) (9) Duration of surgery (hours) (10) Duration of CPB (hours) (11) Duration of postoperative mechanical ventilation (hours) (12) Duration of ICU stay (hours) (13) Mortality (all-cause death and cardiovascular death) (14) Heparin concentration of salvaged RBCs after processing remaining blood in the CPB circuit in the Cell Saver Elite Plus (15) Amount of protamine sulfate administered in the operating room and within 12 hours from the end of surgery | — |
Contacts
Public ContactAkito Tsukinaga
National Cerebral and Cardiovascular Center
Outcome results
None listed