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NCT Number: NCT07669155

Acute Normovolemic Hemodilution in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location contact

Min Yan, Doctor

CONTACT

[email protected]

+86 15888210247

Min Yan, Doctor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The rate of perioperative transfusion of allogeneic blood products

    Time frame: hospital discharge, an average of 10 days

    This includes blood products such as plasma and platelets, erythrocytes

  2. Wound drainage volume

    Time frame: hospital discharge, an average of 10 days

    Accumulated amount of wound drainage after surgery

  3. Unplanned re-operation

    Time frame: hospital discharge, an average of 10 days

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

  4. Perioperative hemoglobin concentration

    Time frame: hospital discharge, an average of 10 days

    hemoglobin concentration during hospitalization

  5. The coagulation function tests during the perioperative period

    Time frame: hospital discharge, an average of 10 days

    This includes thromboelastography result

  6. Complication

    Time frame: hospital discharge, an average of 10 days

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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