Transfusion in Cardiac Valve Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Restrictive Transfusion Strategy, Liberal Transfusion Strategy.
- Who it may be relevant to
- Registry conditions: Cardiac Surgery With Cardiopulmonary Bypass, Valve Heart Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery
Overview
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
- Other Restrictive Transfusion Strategy
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 - Other Liberal Transfusion Strategy
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
Primary outcome measures
- A composite of postoperative morbidity and mortality [Time frame: Postoperative 6 months]
Secondary outcome measures (11)
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT06332547 · TICVS