Acute Normovolemic HemodilutionNCT07669155
Acute Normovolemic Hemodilution in Bone Cancer Surgery
A study testing Acute Normovolemic Hemodilution in people with Acute Normovolemic Hemodilution, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in China.
Trial summary
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Normovolemic Hemodilution
- 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
- 420 participants
- Where
- 8 sitesChina
- Study dates
- Oct 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 more than years;
- undergoing elective bone cancer resection surgery;
- preoperative hemoglobin ≥12 g/dL;
Who cannot join
- anticipated tourniquet use, endovascular balloon occlusion of the aorta or biopsy only;
- weight < 50Kg or > 100Kg;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
- cardiopulmonary insufficiency;
- hepatic and renal dysfunction;
- active infectious disease;
Show all 9Show fewer
- allergy to colloid solution;
- pregnancy;
- declined participation in the study or declined blood transfusion
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Peking University First Hospital
Beijing, 100034
Beijing Jishuitan Hospital
Beijing, 100035
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, +86 15888210247, zryanmin@zju.edu.cn
Min Yan, Doctor
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200080
Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, 200233
West China Hospital, Sichuan University
Sichuan, 610041
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022
About this study
Official title: The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for malignant bone tumors often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.
Read the detailed description
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for bone cancer often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Therefore, it is particularly important to develop a perioperative blood management (PBM) plan for these patients. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.
- Conditions
- Acute Normovolemic Hemodilution
- Being tested
- Acute Normovolemic Hemodilution
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 whole blood is withdrawn after induction of anesthesia. Blood is withdrawn from a large-bore catheter and stored in blood bags. Meanwhile, patients receive colloid solution according to the volume of blood withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Except for not undergoing ANH, other care managements are the same as the experimental group |
| ANH group | Experimental | Patients in the ANH group had whole blood withdrawn after induction of anesthesia. Meanwhile, patients receive colloid solution according to the volume of blood withdrawn. Receives: Procedure: Acute Normovolemic Hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative red blood cell transfusion rate
The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.
Measured: hospital discharge, an average of 10 days
Secondary outcomes (6)
The rate of perioperative transfusion of allogeneic blood products
This includes blood products such as plasma and platelets, erythrocytes
Measured: hospital discharge, an average of 10 days
Wound drainage volume
Accumulated amount of wound drainage after surgery
Measured: hospital discharge, an average of 10 days
Unplanned re-operation
Unplanned re-operation due to bleeding, infection or other reasons
Measured: hospital discharge, an average of 10 days
Perioperative hemoglobin concentration
hemoglobin concentration during hospitalization
Measured: hospital discharge, an average of 10 days
The coagulation function tests during the perioperative period
This includes thromboelastography result
Measured: hospital discharge, an average of 10 days
Complication
embolic events, pulmonary complications, infection, acute kidney injury, death. Diagnose according to radiologic examination, sign and symptom
Measured: hospital discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 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
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669155
- Sponsor's protocol ID
- 2026 0947
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery
- ClinicalTrials.gov ID
- NCT07669155
- Acronym / sponsor ID
- 2026 0947
- Conditions
- Acute Normovolemic Hemodilution
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (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.
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for malignant bone tumors often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.
Detailed description
Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for bone cancer often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Therefore, it is particularly important to develop a perioperative blood management (PBM) plan for these patients. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in 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 |
|---|---|---|
| Control group | No intervention | –Except for not undergoing ANH, other care managements are the same as the experimental group |
| ANH group | Experimental | Procedure: Acute Normovolemic HemodilutionPatients in the ANH group had whole blood withdrawn after induction of anesthesia. Meanwhile, patients receive colloid solution according to the volume of blood withdrawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 more than years;
- undergoing elective bone cancer resection surgery;
- preoperative hemoglobin ≥12 g/dL;
Key exclusion criteria (9 listed)
- anticipated tourniquet use, endovascular balloon occlusion of the aorta or biopsy only;
- weight < 50Kg or > 100Kg;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
- cardiopulmonary insufficiency;
- hepatic and renal dysfunction;
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 whole blood is withdrawn after induction of anesthesia. Blood is withdrawn from a large-bore catheter and stored in blood bags. Meanwhile, patients receive colloid solution according to the volume of blood withdrawn. | Procedure or surgery | ANH group |
Primary outcome
Perioperative red blood cell transfusion rate
Time frame: hospital discharge, an average of 10 days
The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.
6 secondary outcomes
The rate of perioperative transfusion of allogeneic blood products
Time frame: hospital discharge, an average of 10 days
Wound drainage volume
Time frame: hospital discharge, an average of 10 days
Unplanned re-operation
Time frame: hospital discharge, an average of 10 days
Perioperative hemoglobin concentration
Time frame: hospital discharge, an average of 10 days
The coagulation function tests during the perioperative period
Time frame: hospital discharge, an average of 10 days
Complication
Time frame: hospital discharge, an average of 10 days
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 30 Sep 2026.
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Acute Normovolemic Hemodilution
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
8 sites 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, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites 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 9 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Perioperative red blood cell transfusion rate (time frame: hospital discharge, an average of 10 days). 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 30 Sep 2026.