Acute Normovolemic Hemodilution
Conditions
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.
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
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative red blood cell transfusion rate | hospital discharge, an average of 10 days | The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of perioperative transfusion of allogeneic blood products | hospital discharge, an average of 10 days | This includes blood products such as plasma and platelets, erythrocytes |
| Wound drainage volume | hospital discharge, an average of 10 days | Accumulated amount of wound drainage after surgery |
| Unplanned re-operation | hospital discharge, an average of 10 days | Unplanned re-operation due to bleeding, infection or other reasons |
| Perioperative hemoglobin concentration | hospital discharge, an average of 10 days | hemoglobin concentration during hospitalization |
| The coagulation function tests during the perioperative period | hospital discharge, an average of 10 days | This includes thromboelastography result |
| Complication | hospital discharge, an average of 10 days | embolic events, pulmonary complications, infection, acute kidney injury, death. Diagnose according to radiologic examination, sign and symptom |
Countries
China
Outcome results
None listed