Transfusion in Cardiac Valve Surgery

NCT06332547 | Not Yet Recruiting DMC

• 1 other identifier: TICVS
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery With Cardiopulmonary Bypass; Valve Heart Disease

Keywords

cardiac valve surgery; transfusion; transfusion threshold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Rate of reoperation

  Postoperative 6 months

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Restrictive transfusion strategy

ACTIVE COMPARATOR

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

Liberal Transfusion Strategy

ACTIVE COMPARATOR

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

Interventions

Restrictive Transfusion Strategy OTHER

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

Restrictive transfusion strategy

Liberal Transfusion Strategy OTHER

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

Liberal Transfusion Strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510145, China

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Huang Huanlei, Phd

  hhuanlei@hotmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Huanlei, Phd

CONTACT

765-714-9765; hhuanlei@hotmail.com

Zhang Zhaolong, BD

CONTACT

765-714-9765; zhangzhlong1104@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)