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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06332547
Other study ID # TICVS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 30, 2027

Study information

Verified date February 2024
Source Guangdong Provincial People's Hospital
Contact Huang Huanlei, Phd
Phone 765-714-9765
Email hhuanlei@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 1600
Est. completion date December 30, 2027
Est. primary completion date December 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

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
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

Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ) Postoperative 6 months
Secondary Rate of reoperation Postoperative 6 months
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Postoperative thoracic fluid volume in the first 24 hours The first 24 hours after surgery
Secondary Number of participants with postoperative atrial fibrillation Postoperative 6 months
Secondary Number of participants with new-onset renal failure with dialysis Postoperative 6 months
Secondary Number of participants with acute kidney injury Postoperative 6 months
Secondary Number of participants with delirium Postoperative 6 months
Secondary 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
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