Clinical trial NCT06332547: Transfusion in Cardiac Valve Surgery
Official title: A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Surgery With Cardiopulmonary Bypass
Valve Heart Disease
Keywords: cardiac valve surgery
transfusion
transfusion threshold
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: A composite of postoperative morbidity and mortality
timeFrame: Postoperative 6 months
Secondary outcomes:
measure: Rate of reoperation
timeFrame: Postoperative 6 months
measure: Length of ICU Stays
timeFrame: 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.
measure: Length of Postoperative Hospital Stay
timeFrame: 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.
measure: Number of Blood Transfusion
timeFrame: 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.
measure: Duration of mechanical ventilation
timeFrame: 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.
measure: Postoperative thoracic fluid volume in the first 24 hours
timeFrame: The first 24 hours after surgery
measure: Number of participants with postoperative atrial fibrillation
timeFrame: Postoperative 6 months
measure: Number of participants with new-onset renal failure with dialysis
timeFrame: Postoperative 6 months
measure: Number of participants with acute kidney injury
timeFrame: Postoperative 6 months
measure: Number of participants with delirium
timeFrame: Postoperative 6 months
measure: Hospitalization expense
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: hhuanlei@hotmail.com
name: Huang Huanlei, Phd
role: PRINCIPAL_INVESTIGATOR
References: