NCT06459141

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Normovolemic Hemodilution
• Bone Tumor
• Goal-Directed Fluid Therapy
• Transfusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-07
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-06-14
• Last updated: 2025-03-14

Locations

1 site across 1 country: China