Acute Normovolemic HemodilutionNCT06459141
The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
A study testing acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Bone Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Normovolemic Hemodilution, Bone Tumor, Goal-Directed Fluid Therapy
- What is being tested?
- acute normovolemic hemodilution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to May 2028
- 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
- age 18 to 75 years;
- undergoing elective bone tumor resection surgery;
- preoperative hemoglobin ≥11 g/dL;
Who cannot join
- using a tourniquet;
- palliative operation or minimally invasive surgery;
- BMI<18.5 or >30Kg/m^2;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
- cardiopulmonary insufficiency;
- hepatic and renal dysfunction;
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- active infectious disease;
- allergy to succinyl gelatin;
- pregnancy;
- declined participation in the study or declined blood transfusion
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
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 15888210247, zryanmin@zju.edu.cn
Min Yan, Doctor
About this study
Official title: The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Read the detailed description
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
- Being tested
- acute normovolemic hemodilution
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute normovolemic hemodilutionProcedure or surgery
The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability.
| Study group | Role | What they receive |
|---|---|---|
| acute normovolemic hemodilution group (ANH group) | Experimental | The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery. Receives: Procedure: acute normovolemic hemodilution |
| Standard Group (STD group) | No intervention | After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative allogeneic red blood cell transfusion volume
The volume of allogeneic red blood cell transfusions during the intraoperative period.
Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.
Measured: From the beginning to the end of the surgery
Secondary outcomes (9)
The rate of perioperative transfusion of allogeneic blood products
This includes blood products such as plasma and platelets, erythrocytes
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
The blood loss during the perioperative period
The volume of blood loss
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
The volume of fluid administration during the intraoperative period
This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume
Measured: From the beginning to the end of the surgery
The coagulation function tests during the perioperative period
This includes thromboelastography result
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
The intraoperative hemodynamic indexes
This includes stroke volume variation
Measured: From the beginning to the end of the surgery
Perioperative embolic events
This includes thrombosis and embolism
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative pulmonary infection
Diagnose according to radiologic examination, sign and symptom
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative wound infection
Diagnose according to sign, symptom, etc
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
Length of stay in hospital
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start7 Jun 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Normovolemic HemodilutionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459141
- Sponsor's protocol ID
- 2024-0156
- Status last verified
- Jun 2026
- First submitted
- 26 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06459141
- Acronym / sponsor ID
- 2024-0156
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 Jun 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.
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Detailed description
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute normovolemic hemodilution group (ANH group) | Experimental | Procedure: acute normovolemic hemodilutionThe ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery. |
| Standard Group (STD group) | No intervention | –After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 to 75 years;
- undergoing elective bone tumor resection surgery;
- preoperative hemoglobin ≥11 g/dL;
Key exclusion criteria (10 listed)
- using a tourniquet;
- palliative operation or minimally invasive surgery;
- BMI<18.5 or >30Kg/m^2;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
- cardiopulmonary insufficiency;
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 |
|---|---|---|
| acute normovolemic hemodilutionThe ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability. | Procedure or surgery | acute normovolemic hemodilution group (ANH group) |
Primary outcome
Intraoperative allogeneic red blood cell transfusion volume
Time frame: From the beginning to the end of the surgery
The volume of allogeneic red blood cell transfusions during the intraoperative period. Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.
9 secondary outcomes
The rate of perioperative transfusion of allogeneic blood products
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
The blood loss during the perioperative period
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
The volume of fluid administration during the intraoperative period
Time frame: From the beginning to the end of the surgery
The coagulation function tests during the perioperative period
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
The intraoperative hemodynamic indexes
Time frame: From the beginning to the end of the surgery
Perioperative embolic events
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative pulmonary infection
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative wound infection
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Length of stay in hospital
Time frame: Through study completion, an average of 1 year
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 25 Jun 2026.
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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.
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Bone Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 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 25 Jun 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative allogeneic red blood cell transfusion volume (time frame: From the beginning to the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.