Cardiac Surgery With Cardiopulmonary Bypass, Valve Heart Disease
Conditions
Keywords
cardiac valve surgery, transfusion, transfusion threshold
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.
Interventions
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
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
| 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 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. |
| Postoperative thoracic fluid volume in the first 24 hours | The first 24 hours after surgery |
| Rate of reoperation | Postoperative 6 months |
| Number of participants with new-onset renal failure with dialysis | Postoperative 6 months |
| Number of participants with acute kidney injury | Postoperative 6 months |
| Number of participants with delirium | 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 |
| Number of participants with postoperative atrial fibrillation | Postoperative 6 months |
Countries
China
Contacts
Primary ContactHuang Huanlei, Phd
Backup ContactZhang Zhaolong, BD
Outcome results
None listed