Transfusion in Cardiac Valve Surgery

Valve Heart Disease Clinical Trial

— TICVS  

Official title:

A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332547
• Other study ID #: TICVS
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Surgery With Cardiopulmonary Bypass
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

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