Cell saver autologous blood transfusion versus allogenic transfusion in cardiovascular surgery

JRCT ID: jRCT1052240102

Registered date:01/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing cardiovascular surgery
• Date of first enrollment: 22/08/2024
• Target sample size: 142
• Study type: Interventional

Intervention(s)

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 withdrawal from the CPB (when protamine administration is started) if anemia (hemoglobin less than 10.0 g/dL) is confirmed or anticipated.

The intervention group prefers washed autologous blood to allogeneic red blood cell products for anemia from the weaning from cardiopulmonary bypass (at the start of infusion of protamine sulfate) until the patient leaves the operating room. If the anemia has not been corrected or is expected to remain uncorrected after transfusion of washed autologous blood, allogeneic red blood cell products should be transfused. If washed autologous blood is generated during allogeneic red blood cell product transfusion, transfusion of allogeneic red blood cells is stopped, and transfusion of washed autologous blood is initiated. Suppose no washed autologous blood is generated when anemia, allogeneic red blood cell products should be transfused. After weaning from the cardiopulmonary bypass, the remaining blood in the circuit is promptly collected in an autologous blood device reservoir, washed, and transfused.
Only an allogeneic red blood cell product is used for anemia after arriving at the ICU.

In the control group, allogeneic red blood cells will be transfused exclusively to treat anemia from weaning from the cardiopulmonary bypass. Bleeding on the surgical field and remaining blood in the cardiopulmonary bypass will be collected into a salvage autotransfusion device. However, autologous blood returned to a dedicated bag will not be transfused.

Outcome(s)

• Primary Outcome: Total drainage output after 12 hours of admission to the ICU

Secondary Outcome

(1) Transfusion volume in the operating room (RBC/FFP/PC/cryoprecipitate)
(2) Transfusion volume after 12 hours of admission to the ICU (RBC/FFP/PC)
(3) Prevalence of re-thoracotomy during 48hours from admission to the ICU
(4) Prevalence of the total drainage output after 12 hours of admission to the ICU >=1000mL
(5) Prevalence of massive bleeding (meets criteria, (3) or (4))
(6) Results of blood viscosity testing upon ICU admission, PT, APTT, and platelet count
(7) Duration of surgery (hours)
(8) Duration of CPB (hours)
(9) Duration of postoperative mechanical ventilation (hours)
(10) Duration of ICU stay (hours)
(11) Mortality (all-cause death and cardiovascular death)
(12) Prevalence of any of the following infections (surgical site infection, mediastinitis, urinary tract infection, respiratory infections, central nervous system infection, gastrointestinal system infection, skin and soft tissue infection, etc)
(13) Heparin concentration of washed blood cells after processing remaining blood in the CPB circuit in the cell salvage device
(14) Amount of protamine sulfate in the OR and 12 hours after admission to the ICU.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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, 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

Exclude criteria

1)Descending aorta or thoracic and abdominal allograft replacement, heart transplantation, ventricular assist device implantation, or pulmonary valve replacement
2)At risk of extremely high bleeding
3)Patients with known coagulation disorders
4)Patients taking antiplatelet agents or anticoagulants that do not comply with the following withdrawal periods
a)Aspirin: 7 days
b)Clopidogrel, Prasugrel. Ticlopidine: 14 days
c)Cilostazol: 3 days
d)Warfarin: 5 days
e)Direct oral anticoagulants: 3 days
5)Patients taking steroids or immunosuppressive drugs at the time of consent
6)Chronic kidney disease on hemodialysis
7)Patients with PT-INR >=1.5, APTT >= 50 seconds, and platelet count <= 100,000/mcL at the time of consent(excluding patients taking warfarin or direct oral anticoagulants at the time of consent)
8)Patients with active bacterial or viral infections
9)Patients who are pregnant or breastfeeding
10)Patients judged inappropriate for participation by the researchers

Related Information

• Primary Sponsor: Tsukinaga Akito
• Source(s) of Monetary Support: National Cerebral Cardiovascular Center