Acute Normovolemic Hemodilution in Bone Cancer Surgery

NCT07669155 | Not Yet Recruiting DMC

• 1 other identifier: 2026 0947
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The rate of perioperative transfusion of allogeneic blood products

  hospital discharge, an average of 10 days

• Wound drainage volume

  hospital discharge, an average of 10 days

• Unplanned re-operation

  hospital discharge, an average of 10 days

• Perioperative hemoglobin concentration

  hospital discharge, an average of 10 days

• The coagulation function tests during the perioperative period

  hospital discharge, an average of 10 days

Study Arms (2)

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.

Procedure: Acute Normovolemic Hemodilution

Interventions

Acute Normovolemic Hemodilution PROCEDURE

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.

ANH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 more than years;
• undergoing elective bone cancer resection surgery;
• preoperative hemoglobin ≥12 g/dL;

You may not qualify if:

• 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;
• allergy to colloid solution;
• pregnancy;
• declined participation in the study or declined blood transfusion

Sponsors & Collaborators

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

Study Sites (8)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Jishuitan Hospital

Beijing, 100035, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200080, China

Location

Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

Shanghai, 200233, China

Location

West China Hospital, Sichuan University

Sichuan, 610041, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430022, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-06

Locations

CN (8)