Transfusion in Cardiac Valve Surgery (TICVS)

March 26, 2024 updated by: Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510145
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Huang huanlei, Phd
        • Principal Investigator:
          • Zhao Junfei, Phd
        • Principal Investigator:
          • He Biaochuan, Phd
        • Principal Investigator:
          • Zhang Zhaolong, BD
        • Principal Investigator:
          • Wang Zhenzhong, MD
        • Principal Investigator:
          • Wang Qiuji, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Restrictive transfusion strategy

Restrictive transfusion strategy: Blood transfusion triggers of Hb valve less than 6.0g/dL or Hct value less than 18% during CPB, Hb valve less than 7.0g/dL or Hct value less than 21% in ICU or general ward.

Red blood cell transfusion will be given when Hct values fall below 18% or Hb fall below 6.0g/dL during CPB, 2 units RBC transfusion will be administered. In ICU or general ward after surgery, RBC transfusion will be given when Hct values fall below 21% or Hb fall below 7.0g/dL during CPB, 2 unit RBC transfusion will be administered. Following administration of the 2 units transfusion a repeat HCT or Hb is performed, if their values greater than threshold, no further transfusions will be administered, or will be received 2 units RBC again.
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
Active Comparator: Liberal Transfusion Strategy

Liberal Transfusion Strategy: Blood transfusion triggers of Hb valve less than 8.0g/dL or Hct value less than 24% during CPB, Hb valve less than 10.0g/dL or Hct value less than 30% in ICU or general ward.

Red blood cell transfusion will be given when Hct values fall below 24% or Hb fall below 8.0g/dL during CPB, 2 units RBC transfusion will be administered. In ICU or general ward after surgery, RBC transfusion will be given when Hct values fall below 30% or Hb fall below 10.0g/dL during CPB, 2 units RBC transfusion will be administered. Following administration of the 2 units transfusion a repeat HCT or Hb is performed, if their values greater than threshold, no further transfusions will be administered, or will be received 2 units RBC again.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of postoperative morbidity and mortality
Time Frame: 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 )
Postoperative 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of reoperation
Time Frame: Postoperative 6 months
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.
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.
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.
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.
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
The first 24 hours after surgery
Number of participants with postoperative atrial fibrillation
Time Frame: Postoperative 6 months
Postoperative 6 months
Number of participants with new-onset renal failure with dialysis
Time Frame: Postoperative 6 months
Postoperative 6 months
Number of participants with acute kidney injury
Time Frame: Postoperative 6 months
Postoperative 6 months
Number of participants with delirium
Time Frame: Postoperative 6 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Huang Huanlei, Phd, hhuanlei@hotmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TICVS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Baseline Characteristics, Outcome Measures, Adverse Events and so on

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Valve Heart Disease

Clinical Trials on Restrictive Transfusion Strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe