The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

Zhejiang University

Status: Enrolling

Conditions: Bone Tumor; Acute Normovolemic Hemodilution; Goal-Directed Fluid Therapy; Transfusion

Treatments: Procedure: acute normovolemic hemodilution

Study type: Interventional

Funder types: Other

Identifiers

NCT06459141

2024-0156

Details and patient eligibility

About

The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.

Full description

Bone tumor surgery is associated with a significant risk of perioperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.

Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.

Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on Intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion when applying GDFT in patients undergoing bone tumor surgery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 to 75 years;
2. undergoing elective bone tumor resection surgery;
3. preoperative hemoglobin ≥11 g/dL;

Exclusion criteria

1. using a tourniquet;
2. palliative operation or minimally invasive surgery;
3. BMI<18.5 or >30Kg/m^2;
4. international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
5. cardiopulmonary insufficiency;
6. hepatic and renal dysfunction;
7. active infectious disease;
8. allergy to succinyl gelatin;
9. pregnancy;
10. declined participation in the study or declined blood transfusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

acute normovolemic hemodilution group (ANH group)

Experimental group

Description:

The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery.

Treatment:

Procedure: acute normovolemic hemodilution

Standard Group (STD group)

No Intervention group

Description:

After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery.