This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.
Patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. Patients are included in this research when their Hct meets 24% during CPB. Arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after CPB start and 0.5h before CPB finish. Arterial blood gas analysis will be done every 4h in intensive care unit(ICU) and everyday in general ward. Restrictive-threshold group: The transfusion threshold is Hemoglobin(Hb) ≤ 6.0g/dL or Hct ≤ 18% during CPB; postoperative Hb ≤ 7.0g/dL or Hct ≤ 21% in ICU or general ward. Liberal-threshold group: The transfusion threshold is Hb ≤ 8.0g/dL or Hct ≤ 24% during CPB; postoperative Hb ≤ 10.0g/dL or Hct ≤ 30% in ICU or general ward. If the Hb or Hct fall below the threshold at any time, 2 unit of blood cells is administered as soon as possible. Test Hb or Hct again, if is under the threshold 2 unit blood cells will be given until reach the threshold.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,600
Blood transfusion at HCT less than 21% or Hb less than 6.0g/dL during CPB, at HCT less than 21% or Hb less than 7.0g/dL in ICU or general ward after surgery
Blood transfusion at HCT less than 24% or Hb less than 8.0g/dL during CPB, at HCT less than 30% or Hb less than 10.0g/dL in ICU or general ward after surgery
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
A composite of postoperative morbidity and mortality
The composite components are postoperative mortality, infectious morbidity(wound infection, septicemia, or sepsis), ischemic event(myocardial infarction, stroke, renal infraction, bowel infraction )
Time frame: Postoperative 6 months
Rate of reoperation
Time frame: Postoperative 6 months
Length of ICU Stays
Time frame: From date of the end of operation until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.
Length of Postoperative Hospital Stay
Time frame: From date of discharging from ICU until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 2 months.
Number of Blood Transfusion
Time frame: From date of beginning of surgery until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months.
Duration of mechanical ventilation
Time frame: From date of the end of surgery until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.
Postoperative thoracic fluid volume in the first 24 hours
Time frame: The first 24 hours after surgery
Number of participants with postoperative atrial fibrillation
Time frame: Postoperative 6 months
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Number of participants with new-onset renal failure with dialysis
Time frame: Postoperative 6 months
Number of participants with acute kidney injury
Time frame: Postoperative 6 months
Number of participants with delirium
Time frame: Postoperative 6 months
Hospitalization expense
Time frame: From date of being admitted to hospital until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months