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Not yet recruitingNCT07669155Updated Sep 30, 2026

Acute Normovolemic Hemodilution in Bone Cancer Surgery

An interventional study of Acute Normovolemic Hemodilution in Acute Normovolemic Hemodilution, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Normovolemic Hemodilution
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age 18 more than years;
  2. undergoing elective bone cancer resection surgery;
  3. preoperative hemoglobin ≥12 g/dL;

Exclusion criteria

Exclusion Criteria:

  1. anticipated tourniquet use, endovascular balloon occlusion of the aorta or biopsy only;
  2. weight \< 50Kg or > 100Kg;
  3. international normalized ratio (INR) >1.5 or platelet count \<100 × 10\^9/L;
  4. cardiopulmonary insufficiency;
  5. hepatic and renal dysfunction;
  6. active infectious disease;
  7. allergy to colloid solution;
  8. pregnancy;
  9. declined participation in the study or declined blood transfusion
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
420 participants (estimated)

Study arms

  • No intervention
    Control group

    Except for not undergoing ANH, other care managements are the same as the experimental group

  • Experimental
    ANH group

    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.

    Procedure: Acute Normovolemic Hemodilution

Interventions

  • ProcedureAcute Normovolemic Hemodilution

    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.

05

What researchers measure

Primary outcomes

  1. Perioperative red blood cell transfusion rate

    The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.

    Time frame: hospital discharge, an average of 10 days

Secondary outcomes

  1. The rate of perioperative transfusion of allogeneic blood products

    This includes blood products such as plasma and platelets, erythrocytes

    Time frame: hospital discharge, an average of 10 days

  2. Wound drainage volume

    Accumulated amount of wound drainage after surgery

    Time frame: hospital discharge, an average of 10 days

  3. Unplanned re-operation

    Unplanned re-operation due to bleeding, infection or other reasons

    Time frame: hospital discharge, an average of 10 days

  4. Perioperative hemoglobin concentration

    hemoglobin concentration during hospitalization

    Time frame: hospital discharge, an average of 10 days

  5. The coagulation function tests during the perioperative period

    This includes thromboelastography result

    Time frame: hospital discharge, an average of 10 days

  6. Complication

    embolic events, pulmonary complications, infection, acute kidney injury, death. Diagnose according to radiologic examination, sign and symptom

    Time frame: hospital discharge, an average of 10 days

06

Study locations

8 sites
  • The Second Affiliated Hospital of Zhejiang University anesthesiology department
    Hangzhou, Zhejiang 310000, China
    • Min Yan, Doctor · Contact · zryanmin@zju.edu.cn · +86 15888210247
    • Min Yan, Doctor · Principal investigator
  • Peking University First Hospital
    Beijing, 100034, China
  • Beijing Jishuitan Hospital
    Beijing, 100035, China
  • Fudan University Shanghai Cancer Center
    Shanghai, 200032, China
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, 200080, China
  • Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
    Shanghai, 200233, China
  • West China Hospital, Sichuan University
    Sichuan, 610041, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, 430022, China
07

Registry details

Key details

Study ID
NCT07669155
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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