Transfusion in Cardiac Valve Surgery
- Conditions
- Cardiac Surgery With Cardiopulmonary BypassValve Heart Disease
- Interventions
- Other: Liberal Transfusion StrategyOther: Restrictive Transfusion Strategy
- Registration Number
- NCT06332547
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1600
- All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained
- Pregnant or maternal women Age less than 18 years or more than 80 years Undergo coronary artery bypass or large cardiac vessels procedure Emergencies Have been attended other researches Unable to receive blood for religious reasons Drug addict or malignant tumor patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liberal Transfusion Strategy Liberal Transfusion Strategy Liberal Transfusion Strategy: Blood transfusion triggers of Hb valve less than 8.0g/dL or Hct value less than 24% during CPB, Hb valve less than 10.0g/dL or Hct value less than 30% in ICU or general ward. Red blood cell transfusion will be given when Hct values fall below 24% or Hb fall below 8.0g/dL during CPB, 2 units RBC transfusion will be administered. In ICU or general ward after surgery, RBC transfusion will be given when Hct values fall below 30% or Hb fall below 10.0g/dL during CPB, 2 units RBC transfusion will be administered. Following administration of the 2 units transfusion a repeat HCT or Hb is performed, if their values greater than threshold, no further transfusions will be administered, or will be received 2 units RBC again. Restrictive transfusion strategy Restrictive Transfusion Strategy Restrictive transfusion strategy: Blood transfusion triggers of Hb valve less than 6.0g/dL or Hct value less than 18% during CPB, Hb valve less than 7.0g/dL or Hct value less than 21% in ICU or general ward. Red blood cell transfusion will be given when Hct values fall below 18% or Hb fall below 6.0g/dL during CPB, 2 units RBC transfusion will be administered. In ICU or general ward after surgery, RBC transfusion will be given when Hct values fall below 21% or Hb fall below 7.0g/dL during CPB, 2 unit RBC transfusion will be administered. Following administration of the 2 units transfusion a repeat HCT or Hb is performed, if their values greater than threshold, no further transfusions will be administered, or will be received 2 units RBC again.
- Primary Outcome Measures
Name Time Method A composite of postoperative morbidity and mortality Postoperative 6 months The composite components are postoperative mortality, infectious morbidity(wound infection, septicemia, or sepsis), ischemic event(myocardial infarction, stroke, renal infraction, bowel infraction )
- Secondary Outcome Measures
Name Time Method Length of Postoperative Hospital Stay 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 participants with acute kidney injury Postoperative 6 months Postoperative thoracic fluid volume in the first 24 hours The first 24 hours after surgery Rate of reoperation Postoperative 6 months Number of Blood Transfusion 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 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. Number of participants with new-onset renal failure with dialysis Postoperative 6 months Number of participants with delirium Postoperative 6 months Length of ICU Stays 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. Number of participants with postoperative atrial fibrillation Postoperative 6 months Hospitalization expense 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
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China