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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

Other trials in China

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.

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 groups in NCT06399536
Study groupRoleWhat they receive
ANH groupExperimentalParticipants 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 groupNo interventionParticipants 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.

  1. ABT requirement

    The perioperative allogeneic red blood cells consumption (Units per person).

    Measured: Up to 12 weeks.

Secondary outcomes (5)
  1. Proportion of transfused participants

    The proportion of participants receiving allogeneic red blood cells.

    Measured: Up to 12 weeks.

  2. 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.

  3. Length of hospital stay

    The time from the day of admission to discharge from the hospital (Unit: days).

    Measured: Up to 12 weeks.

  4. Postoperative hospital stay

    The time from the day of surgery to discharge from the hospital (Unit: days).

    Measured: Up to 12 weeks.

  5. 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.

  1. First posted3 May 2024
  2. Study start1 Jun 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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