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Acute Normovolemic Hemodilution in Bone Cancer Surgery

No phase Interventional Acute Normovolemic Hemodilution

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute Normovolemic Hemodilution.
Who it may be relevant to
Registry conditions: Acute Normovolemic Hemodilution. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Perioperative red blood cell transfusion rate [Time frame: hospital discharge, an average of 10 days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • using a tourniquet;
  • BMI<18.5 Kg/m\^2;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou

Identifiers

NCT: NCT07669155 · 2026 0947

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗