The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Tumor; Transfusion; Acute Normovolemic Hemodilution; Goal-Directed Fluid Therapy
• Intervention / Treatment: Procedure: acute normovolemic hemodilution

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Contact: Min Yan, Doctor; Phone Number: 15888210247; Email: zryanmin@zju.edu.cn
      • Contact: Min Yan, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acute normovolemic hemodilution group (ANH group); The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery.	Procedure: acute normovolemic hemodilution; The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability.
No Intervention: Standard Group (STD group); After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative allogeneic red blood cell transfusion volume	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.	From the beginning to the end of the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms
• Other Study ID Numbers: 2024-0156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No