Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06399536

Individualized Acute Normovolemic Hemodilution for Non-cardiac Surgery With Anticipated High-dose Red Cells Transfusion

Led by West China Hospital · Updated on 2024-12-04

40

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating an individualized acute normovolemic hemodilution (ANH) technique to reduce the need for red blood cell transfusions during elective non-cardiac surgeries with expected major blood loss in adults aged 18 to 75 years. The study aims to address concerns about complications related to allogeneic blood transfusions and improve blood management during surgery by tailoring the ANH process to each patient using the West-China-Liu's Score. Participants in the trial will be randomly assigned to either receive individualized ANH based on the West-China-Liu's Score after anesthetic induction or to receive routine clinical care guided by standard transfusion guidelines. The individualized ANH involves collecting autologous blood while infusing fluids to maintain blood volume, with transfusions managed according to the patient's calculated tolerable hemoglobin level. This method aims to safely reduce red cell loss during surgery. During the study, researchers will monitor participants for the requirement of allogeneic blood transfusions up to 12 weeks post-surgery. Additional assessments include the proportion of patients receiving transfusions, in-hospital complications, duration of hospital and postoperative stays, and total hospital costs. Safety and outcomes will be evaluated through standard clinical monitoring throughout the hospital stay and follow-up period.

CONDITIONS

Brief Title

Individualized ANH for Non-cardiac Surgery

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective non-cardiac surgery with an anticipated red blood cells transfusion >8 units (or 1600ml)
  • Aged 18 to 75 years
  • Preoperative hemoglobin level >120g/L for men and >110g/L for women
Not Eligible

You will not qualify if you...

  • Refusal of blood transfusion
  • Cardiopulmonary insufficiency
  • Cerebrovascular disease
  • Renal impairment
  • Hemoglobinopathies or blood system diseases
  • Other situations not suitable for inclusion in clinical trial

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During surgery

Participants undergo individualized acute normovolemic hemodilution (ANH) based on the West-China Liu's Score after anesthetic induction during elective non-cardiac surgery. The decision for autologous or allogeneic red cell transfusion is made according to this score.

1 surgical procedure visit (in-person)

Follow-up

Duration - Up to 12 weeks

Participants are monitored for up to 12 weeks after surgery to assess transfusion requirements, complications, and recovery outcomes.

Regular post-operative visits according to clinical practice

Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

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Research Team

R

Ren Liao, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Individualised acute normovolaemic haemodilution for non-cardiac surgery with anticipated high-dose red cell transfusion: study protocol for a randomised controlled trial in West China Hospital of Sichuan University.

Chenxi Liao, Jinzhe Tan, Jingjing An...

https://pubmed.ncbi.nlm.nih.gov/39753262