Clinical trial NCT06881498: A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Official title: A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Tumor
Acute Normovolemic Hemodilution
Goal-Directed Fluid Therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 32
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 perioperative anemia 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 improve postoperative hemoglobin levels 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, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss 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. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels 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: Hemoglobin concentration on the first day after surgery
timeFrame: The first day after 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: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
References: