Bone TumorNCT06881498
A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
A study testing acute normovolemic hemodilution in people with Bone Tumor and Acute Normovolemic Hemodilution, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Tumor, Acute Normovolemic Hemodilution, 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to May 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
- 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
The prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.
Read the detailed description
Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss 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, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor 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.
Hemoglobin concentration on the first day after surgery
The concentration of hemoglobin on the first day after surgery
Measured: The first day after surgery
Secondary outcomes (7)
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
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
Measured: From the start of surgery to discharge or the 7th day following the operation, which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start7 Jun 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881498
- Sponsor's protocol ID
- 2024 0584
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
- ClinicalTrials.gov ID
- NCT06881498
- Acronym / sponsor ID
- 2024 0584
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Mar 2025 (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 perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.
Detailed description
Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss 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, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor 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
Hemoglobin concentration on the first day after surgery
Time frame: The first day after surgery
The concentration of hemoglobin on the first day after surgery
7 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
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
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 15 Apr 2025.
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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 Bone Tumor and Acute Normovolemic Hemodilution, 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 15 Apr 2025. 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?
Hemoglobin concentration on the first day after surgery (time frame: The first day after 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 15 Apr 2025.