The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

Not Applicable

Recruiting

• Conditions: Bone Tumor; Goal-Directed Fluid Therapy; Transfusion; Acute Normovolemic Hemodilution
• Interventions: Procedure: acute normovolemic hemodilution

• Registration Number: NCT06459141
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-26
• Study Start: 2024-06-07
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-14
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acute normovolemic hemodilution group (ANH group)	acute normovolemic hemodilution	The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery.

Primary Outcome Measures

Name	Time	Method
Intraoperative allogeneic red blood cell transfusion volume	From the beginning to the end of the surgery	The volume of allogeneic red blood cell transfusions during the intraoperative period.; Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.

Secondary Outcome Measures

Name	Time	Method
The blood loss during the perioperative period	From the start of surgery to discharge or the 7th day following the operation, which comes first	The volume of blood loss
The intraoperative hemodynamic indexes	From the beginning to the end of the surgery	This includes stroke volume variation
Perioperative embolic events	From the start of surgery to discharge or the 7th day following the operation, which comes first	This includes thrombosis and embolism
Perioperative pulmonary infection	From the start of surgery to discharge or the 7th day following the operation, which comes first	Diagnose according to radiologic examination, sign and symptom
The rate of perioperative transfusion of allogeneic blood products	From the start of surgery to discharge or the 7th day following the operation, which comes first	This includes blood products such as plasma and platelets, erythrocytes
The volume of fluid administration during the intraoperative period	From the beginning to the end of the surgery	This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume
The coagulation function tests during the perioperative period	From the start of surgery to discharge or the 7th day following the operation, which comes first	This includes thromboelastography result
Length of stay in hospital	Through study completion, an average of 1 year
Perioperative wound infection	From the start of surgery to discharge or the 7th day following the operation, which comes first	Diagnose according to sign, symptom, etc

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department; 🇨🇳 Hangzhou, Zhejiang, China