Individualized ANH for Non-cardiac Surgery
Individualized Acute Normovolemic Hemodilution for Non-cardiac Surgery With Anticipated High-dose Red Cells Transfusion
1 other identifier
interventional
40
1 country
1
Brief Summary
In this trial, we proposed an individualized acute normovolemic hemodilution (ANH), and conduct a randomized controlled trial to testify the effect of individualized ANH on red cells requirement for non-cardiac surgeries with anticipating major blood loss in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 4, 2024
December 1, 2024
2 years
April 29, 2024
December 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ABT requirement
The perioperative allogeneic red blood cells consumption (Units per person).
Up to 12 weeks.
Secondary Outcomes (5)
Proportion of transfused participants
Up to 12 weeks.
Composite of in-hospital complications
Up to 12 weeks.
Length of hospital stay
Up to 12 weeks.
Postoperative hospital stay
Up to 12 weeks.
Total in-hospital cost
Up to 12 weeks.
Study Arms (2)
ANH group
EXPERIMENTALParticipants will undergo individualized ANH based on the West China Liu's Score after anesthetic induction. The decision of autologous blood transfusion or allogeneic red cell transfusion will be made according to the West China Liu's Score.
Control group
NO INTERVENTIONParticipants will be treated as the routine clinical practice. The decision of blood transfusion will be guided as the transfusion guideline.
Interventions
Participants will undergo individualized ANH based on the West China Liu's Score after anesthetic induction. The decision of autologous blood transfusion or allogeneic red cell transfusion will be made according to the West China Liu's Score.
Eligibility Criteria
You may qualify if:
- Patients undergoing elective non-cardiac surgery with an anticipated red blood cells transfusion \>8 units (or 1600ml)
- Aged 18\~75 years
- Preoperative Hb level \> 120g/L for men and \> 110g/L for women.
You may not qualify if:
- Refusal of blood transfusion
- Cardiopulmonary insufficiency
- Cerebrovascular disease
- Renal impairment
- Hemoglobinopathies or blood system diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (1)
Liao C, Tan J, An J, Zhong J, Lai X, Tian L, Liao R. 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. BMJ Open. 2025 Jan 2;15(1):e088326. doi: 10.1136/bmjopen-2024-088326.
PMID: 39753262DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ren Liao
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical investigators, the responsible anesthesiologists and surgeons, the research assistants, and the participants will not be blinded to the treatment assignment, and the statisticians responsible for outcome analysis will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2024
First Posted
May 3, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 4, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 5 years after the completion of the study.
- Access Criteria
- Upon request by email to PI.
Individual participant data (IPD) with anonymity will be uploaded to the IPD sharing platform for data sharing. Data will be available after the agreement of the correspondence author upon reasonable request.