Clinical trial NCT06459141: The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Official title: The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Normovolemic Hemodilution
Bone Tumor
Goal-Directed Fluid Therapy
Transfusion
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative allogeneic red blood cell transfusion volume
timeFrame: From the beginning to the end of the surgery
Secondary outcomes:
measure: The rate of perioperative transfusion of allogeneic blood products
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: The blood loss during the perioperative period
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: The volume of fluid administration during the intraoperative period
timeFrame: From the beginning to the end of the surgery
measure: The coagulation function tests during the perioperative period
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: The intraoperative hemodynamic indexes
timeFrame: From the beginning to the end of the surgery
measure: Perioperative embolic events
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: Perioperative pulmonary infection
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: Perioperative wound infection
timeFrame: From the start of surgery to discharge or the 7th day following the operation, which comes first
measure: Length of stay in hospital
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
References: