Transfusion Related ComplicationNCT06399536
Individualized ANH for Non-cardiac Surgery
A study testing Individualized ANH in people with Transfusion Related Complication and Hemodilution, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transfusion Related Complication, Hemodilution
- What is being tested?
- Individualized ANH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refusal of blood transfusion
- Cardiopulmonary insufficiency
- Cerebrovascular disease
- Renal impairment
- Hemoglobinopathies or blood system diseases
- Other situations not suitable for inclusion in clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: Individualized Acute Normovolemic Hemodilution for Non-cardiac Surgery With Anticipated High-dose Red Cells Transfusion
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.
Read the detailed description
Allogeneic blood transfusion (ABT) is often given for patients undergoing major surgery with large amount of blood loss. However, ABT itself is associated with various complications, such as anaphylaxis, transfusion related bacterial and viral infections, and transfusion related lung injury [1-3]. Strategies for reduction of requirements for ABT during surgery continue to be of an importance in clinical practice.
The current strategies for ABT reduction during major surgery can be divided into the decrease of operative blood loss and the provision of autologous red cells. Collection of autologous red cells could be performed several weeks before admission (preoperative autologous donation, PAD), after anesthetic induction and prior to the surgical incision (acute normovolemic hemodilution, ANH), or during the operation (cell saver) [4]. ANH is a technique that remove the whole blood and infuse the colloids or crystalloids at the same time to get the hemodilution with the normal volume [5]. With the hemodilution, the amounts of red cells lost with bleeding could be reduced during surgery, and blood viscosity could be decreased beneficial for improved blood flow and increased venous return at a relative constant atrial pressure [6]. However, ANH has not been a widely accepted technique despite these advantages. One possible reason could be the mixed results about application of ANH in the literature. It was reported to decrease the risk of ABT when compared with the control group in a meta-analysis including 29 randomized controlled trials [7], but other authors reported ANH could only decrease intraoperative ABT with no differences in overall perioperative transfusion requirements [8]. Another reason could be due to the staffing shortage in clinical practice, especially in China. The implementation of AHN in the operating room requires the cooperation of a staff team including anesthesiologists, circulating nurses, and technicians from department of blood transfusion to collect the autologous blood and store it in refrigerators, and reinfuse the autologous blood under the supervision and double verification. In addition, what degree of the hemodilution should be achieved for a patient is lack of evidence and guidance, and the hemodilution can't be individualized executed.
In our previous study, we proposed the West-China-Liu's Score (Table.1) for individualized transfusion of red cells and conducted a multi-centered RCT to verify that the application of this individualized transfusion strategy can decrease the requirement of perioperative red cells transfusion when compared with the restrictive or liberal strategies without increase of complications in elective noncardiac surgeries [9]. According to the score, we can determine the tolerable lower level of hemoglobin (Hb), and it's safe for a patient to keep his Hb level above the score. With the West-China-Liu's Score, we dilute the patient's Hb level to the degree of the score plus 2, we can calculate the volume of the collected autologous blood. For example, a patient's initial Hb level is 12g/dL, the West-China-Liu's Score is 6, we dilute the Hb level to the score of 6+2=8, and the hemodilution level for him is Hb of 8g/dL. A 1g/dL Hb level is about 400ml of blood, and the decrease of Hb level from 12g/dL to 8g/dL is about 1600ml of blood. While we infuse the patient with fluids and collect blood at the same time, we will collect 800ml of the autologous blood for this patient. The collected autologous blood will be transfused to the patient when his Hb level is decreased to 6g/dL, or at the end of the operation. By this mean, ANH could be individualized.
Based on previous findings and the theory of individualized transfusion strategy, we hypothesize that individualized ANH under guidance of West-China Liu's Score can reduce the requirement of allogeneic red cells.
- Conditions
- Transfusion Related Complication, Hemodilution
- Being tested
- Individualized ANH
- Keywords
- acute normovolemic hemodilution, individualized blood transfusion, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized ANHProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ANH group | Experimental | 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. Receives: Procedure: Individualized ANH |
| Control group | No intervention | Participants will be treated as the routine clinical practice. The decision of blood transfusion will be guided as the transfusion guideline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABT requirement
The perioperative allogeneic red blood cells consumption (Units per person).
Measured: Up to 12 weeks.
Secondary outcomes (5)
Proportion of transfused participants
The proportion of participants receiving allogeneic red blood cells.
Measured: Up to 12 weeks.
Composite of in-hospital complications
The complications will be divided into five grades. Grade Ⅰ, recovery after temporary treatment, e.g., postoperative nausea and vomiting. Grade Ⅱ, prolonged hospitalization, e.g., infection requiring antibiotics treatment. Grade Ⅲ, life threatening complications requiring intense treatment during hospitalization, e.g., postoperative bleeding requiring re-operation, or acute renal insufficiency requiring dialysis therapy. Grade Ⅳ, life threatening complications resulting in significantly decreased quality of life, e.g., myocardial infarction. Grade Ⅴ, all-cause mortality during hospitalization.
Measured: Up to 12 weeks.
Length of hospital stay
The time from the day of admission to discharge from the hospital (Unit: days).
Measured: Up to 12 weeks.
Postoperative hospital stay
The time from the day of surgery to discharge from the hospital (Unit: days).
Measured: Up to 12 weeks.
Total in-hospital cost
Total in-hospital cost
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399536
- Sponsor's protocol ID
- WCH20240429
- Status last verified
- Dec 2024
- First submitted
- 29 Apr 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39753262
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Acute Normovolemic Hemodilution for Non-cardiac Surgery With Anticipated High-dose Red Cells Transfusion
- ClinicalTrials.gov ID
- NCT06399536
- Acronym / sponsor ID
- WCH20240429
- Conditions
- Transfusion Related Complication, Hemodilution
- Keywords
- acute normovolemic hemodilution, individualized blood transfusion, clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allogeneic blood transfusion (ABT) is often given for patients undergoing major surgery with large amount of blood loss. However, ABT itself is associated with various complications, such as anaphylaxis, transfusion related bacterial and viral infections, and transfusion related lung injury [1-3]. Strategies for reduction of requirements for ABT during surgery continue to be of an importance in clinical practice.
The current strategies for ABT reduction during major surgery can be divided into the decrease of operative blood loss and the provision of autologous red cells. Collection of autologous red cells could be performed several weeks before admission (preoperative autologous donation, PAD), after anesthetic induction and prior to the surgical incision (acute normovolemic hemodilution, ANH), or during the operation (cell saver) [4]. ANH is a technique that remove the whole blood and infuse the colloids or crystalloids at the same time to get the hemodilution with the normal volume [5]. With the hemodilution, the amounts of red cells lost with bleeding could be reduced during surgery, and blood viscosity could be decreased beneficial for improved blood flow and increased venous return at a relative constant atrial pressure [6]. However, ANH has not been a widely accepted technique despite these advantages. One possible reason could be the mixed results about application of ANH in the literature. It was reported to decrease the risk of ABT when compared with the control group in a meta-analysis including 29 randomized controlled trials [7], but other authors reported ANH could only decrease intraoperative ABT with no differences in overall perioperative transfusion requirements [8]. Another reason could be due to the staffing shortage in clinical practice, especially in China. The implementation of AHN in the operating room requires the cooperation of a staff team including anesthesiologists, circulating nurses, and technicians from department of blood transfusion to collect the autologous blood and store it in refrigerators, and reinfuse the autologous blood under the supervision and double verification. In addition, what degree of the hemodilution should be achieved for a patient is lack of evidence and guidance, and the hemodilution can't be individualized executed.
In our previous study, we proposed the West-China-Liu's Score (Table.1) for individualized transfusion of red cells and conducted a multi-centered RCT to verify that the application of this individualized transfusion strategy can decrease the requirement of perioperative red cells transfusion when compared with the restrictive or liberal strategies without increase of complications in elective noncardiac surgeries [9]. According to the score, we can determine the tolerable lower level of hemoglobin (Hb), and it's safe for a patient to keep his Hb level above the score. With the West-China-Liu's Score, we dilute the patient's Hb level to the degree of the score plus 2, we can calculate the volume of the collected autologous blood. For example, a patient's initial Hb level is 12g/dL, the West-China-Liu's Score is 6, we dilute the Hb level to the score of 6+2=8, and the hemodilution level for him is Hb of 8g/dL. A 1g/dL Hb level is about 400ml of blood, and the decrease of Hb level from 12g/dL to 8g/dL is about 1600ml of blood. While we infuse the patient with fluids and collect blood at the same time, we will collect 800ml of the autologous blood for this patient. The collected autologous blood will be transfused to the patient when his Hb level is decreased to 6g/dL, or at the end of the operation. By this mean, ANH could be individualized.
Based on previous findings and the theory of individualized transfusion strategy, we hypothesize that individualized ANH under guidance of West-China Liu's Score can reduce the requirement of allogeneic red cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANH group | Experimental | Procedure: Individualized ANHParticipants 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 intervention | –Participants will be treated as the routine clinical practice. The decision of blood transfusion will be guided as the transfusion guideline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Refusal of blood transfusion
- Cardiopulmonary insufficiency
- Cerebrovascular disease
- Renal impairment
- Hemoglobinopathies or blood system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized ANHParticipants 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. | Procedure or surgery | ANH group |
Primary outcome
ABT requirement
Time frame: Up to 12 weeks.
The perioperative allogeneic red blood cells consumption (Units per person).
5 secondary outcomes
Proportion of transfused participants
Time frame: Up to 12 weeks.
Composite of in-hospital complications
Time frame: Up to 12 weeks.
Length of hospital stay
Time frame: Up to 12 weeks.
Postoperative hospital stay
Time frame: Up to 12 weeks.
Total in-hospital cost
Time frame: Up to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 39753262Liao 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ren Liao principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized ANH in people with Transfusion Related Complication and Hemodilution, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ren Liao, M.D. (+86-18980602177, liaoren7733@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABT requirement (time frame: Up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.