Acute Normovolemic Hemodilution in Bone Cancer Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Normovolemic Hemodilution
• Intervention / Treatment: Procedure: Acute Normovolemic Hemodilution

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 Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Principal Investigator: Min Yan, Doctor
      • Contact: Min Yan, Doctor; Phone Number: +86 15888210247; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. using a tourniquet;
2. BMI<18.5 Kg/m^2;
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative red blood cell transfusion rate	The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.	hospital discharge, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of perioperative transfusion of allogeneic blood products	This includes blood products such as plasma and platelets, erythrocytes	hospital discharge, an average of 10 days
Wound drainage volume	Accumulated amount of wound drainage after surgery	hospital discharge, an average of 10 days
Unplanned re-operation	Unplanned re-operation due to bleeding, infection or other reasons	hospital discharge, an average of 10 days
Perioperative hemoglobin concentration	hemoglobin concentration during hospitalization	hospital discharge, an average of 10 days
The coagulation function tests during the perioperative period	This includes thromboelastography result	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	hospital discharge, an average of 10 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026 0947

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No